Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Flohr and colleagues present the results of a controlled trial of cyclosporine vs methotrexate for severe atopic dermatitis ("Efficacy and Safety of Ciclosporin Versus Methotrexate in the Treatment of Severe Atopic Dermatitis in Children and Young People"). Cyclosporine worked faster, yet methotrexate was a bit more effective in the long run. Both treatments had considerable side effects; 10% and 14% had serious events with cyclosporine and methotrexate, respectively. My only quibble is with the first word of the abstract background section; the authors call cyclosporine and methotrexate "conventional" systemic drugs for atopic dermatitis. At this point, considering safety and efficacy, I would consider drugs like dupilumab to be the "conventional" systemic treatment for atopic dermatitis.

Wan and colleagues ("Neuropsychiatric Disorders in Adults With Atopic Dermatitis") present an exceptionally well-done study with a huge patient population. The study compared about 600,000 adults with atopic dermatitis vs over 2,000,000 adults without the disease. A sample size like that offers a lot of power to detect very small differences between groups. The researchers report higher rates of anxiety and depression in patients with atopic dermatitis compared to those without. Are those differences clinically meaningfully different? The rates of depression were 14 and 17 cases per 1000 patient-years for those without and those with severe atopic dermatitis, respectively. That's a difference of 3 per 1000 patient-years. So maybe roughly 300 patients with atopic dermatitis would need to be seen to observe one patient with depression due to atopic dermatitis (assuming that the observed differences in rates between those with and those without atopic dermatitis were due to the dermatitis). The authors conclude, "Clinicians should inquire about mental health in patients with AD." I don't think their data support such a conclusion. We'd need to see a cost-effectiveness study to know if that's an intervention that we should do. Given the very small difference between the rates in those with and those without atopic dermatitis, it might be reasonable to conclude that we should inquire about mental health in patients with atopic dermatitis about as much as we should in patients without atopic dermatitis.

Some years ago, there was an over-the-counter topical product for psoriasis based on a banana peel extract. I think it was marketed as "FDA approved" for psoriasis (which was legal to say because the product also contained tar) and as being as effective as topical calcipotriene as published in the Journal of Investigational Dermatology (JID). I went to look for the article; the "publication" was the abstract of a poster presentation. The study followed a very small study population for a short period of time. The study was, I believe, underpowered to detect differences between the banana peel extract and the vitamin D analog. Those data were presented as a poster, the poster abstracts were printed in JID, and, voilà, the product was marketed as being as effective as topical calcipotriene as published in JID.

Sowlati and colleagues ("Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children") randomly assigned 42 patients to receive either a xyloglucan/pea protein topical therapy or hydrocortisone. The participants were followed for 2 weeks. Both groups improved. We don't know whether they improved more than they would have with moisturizer. This study doesn't make me excited about prescribing the xyloglucan/pea protein topical.

The study by Mohamed and colleagues comparing tacrolimus and hydrocortisone reminds me that we have an effective generic topical anti-inflammatory for our patients with atopic dermatitis. Given the safety of topical tacrolimus, I prefer prescribing the 0.1% ointment for all my patients, though I give the lower concentration, approved for children, if the insurer makes me.

Simpson and colleagues' post hoc analysis of tralokinumab tells us that, with continued use, some patients who don't respond well initially will have greater improvement. But what I'd really like to see is a head-to-head study comparing tralokinumab vs dupilumab. Dupilumab seems to have stronger efficacy based on their reported trial numbers, but a head-to-head trial would give us greater confidence in their relative benefits.

I have trouble getting excited about this study by Cork and colleagues ("Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age With Severe Atopic Dermatitis"). I feel very comfortable with dupilumab already.

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Patients with hand osteoarthritis (OA) and MRI-detected synovitis who took methotrexate (MTX) 20 mg weekly over a 6-month period had a significant and potentially clinically meaningful reduction in pain and stiffness over those who received placebo in the first randomized controlled trial of its kind to show positive results with the drug.

Patients who were randomly assigned to MTX took 10 mg orally for the first 4 weeks then increased to 20 mg for the rest of the trial, with differences in the primary outcome of pain measured by visual analog scale (VAS) first becoming significant over placebo at 3 months.

Senior author of the METHODS study (Methotrexate to Treat Hand Osteoarthritis with Synovitis), Flavia Cicuttini, PhD, MSc, head of the musculoskeletal unit at Monash University and head of rheumatology at Alfred Hospital, Melbourne, Australia, noted that the effect of MTX was higher than effect sizes that have been reported for NSAIDs on pain in hip or knee OA.

Astrid Gast/Thinkstock

The study was published online October 12 in The Lancet.

METHODS makes improvements on past studies

While OA is traditionally categorized as a noninflammatory process, it’s known that there are some patients who have a clinical phenotype characterized by joint swelling (synovitis) and others develop erosive disease. MTX is one of the most common therapies for inflammatory arthritis and standard of care for rheumatoid arthritis (RA) management. Previous studies of methotrexate showed lack of efficacy in hand OA but may have been because of the use of a low dose, poor power due to moderate sample size, and failure to target the specific inflammatory OA phenotype.

Dr. Cicuttini

In an interview, Dr. Cicuttini noted the selection of methotrexate for this trial was intentional. “We considered the evidence and decided to test methotrexate because we know it is effective in inflammatory arthritis, and its mode of action is broader than the more selective anti-TNF [tumor necrosis factor] agents,” which she noted have failed in prior hand OA trials. She also noted that the only previous randomized controlled trial of MTX tested a dose of 10 mg/week, rather than the 20 mg/week dose used in METHODS. 
 

Study details and results

METHODS was a randomized, double-blind, placebo-controlled trial at multiple sites within Australia. Patients were recruited from 2017 to 2022, with a temporary pause in 2020 during the COVID-19 pandemic because of safety concerns regarding MTX use. Participants included in this study were aged 40-75 years, had pain in hand joints for most days in the past 3 months, and a pain score of at least 40 mm on a 100-mm VAS in the past 7 days.

The participants’ hand OA fulfilled American College of Rheumatology criteria, radiographic osteoarthritis (Kellgren and Lawrence grade 2 or more) in at least one joint, and MRI-detected synovitis of grade 1 or more in at least one joint. They excluded patients with concomitant rheumatic disease, gout, psoriasis, positive rheumatoid factor or anti-cyclic citrullinated peptides, or elevated inflammatory markers (erythrocyte sedimentation rate or C-reactive protein), as well as those with contraindication to methotrexate or MRI.

The trials’ 97 participants were assigned 1:1 to MTX or placebo using block randomization. The MTX group started on oral MTX 10 mg weekly for the first 4 weeks, followed by 20 mg weekly for the remainder of the study. Participants took folic acid 5 mg once a day to reduce risk of MTX-related side effects.

The mean age of the participants was 61 years, with 70% female. Baseline characteristics were generally well-balanced, except for higher mean BMI in the MTX group. At 6 months, the MTX group had a greater reduction in mean VAS pain than the placebo group (–15.2 mm vs. –7.7 mm; adjusted between-group difference, –9.9 mm). The minimally clinically important difference for OA trials is a 15-mm change (out of 100) in VAS pain.

The MTX group also had greater reduction in mean Australian Canadian OA Hand Index (AUSCAN) score for pain and stiffness at 6 months, compared with placebo, but there were no differences in other secondary outcomes (mean AUSCAN, Functional Index for Hand Osteoarthritis, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, or grip strength).

MTX was well-tolerated with no serious adverse events related to treatment; only 5 of 50 participants in the MTX group and 4 of 47 in the placebo group discontinued study medication. Incidence of adverse events was similar in the two groups throughout the trial, including mild leukopenia, elevated liver enzymes, mild reduction of hemoglobin, and raised creatinine. None of the laboratory abnormalities required change in medication dosage or affected ability to continue in the study. 
 

Qualifications and considerations for MTX use

Commenting on the study, OA researcher Amanda E. Nelson, MD, MSCR, associate professor of medicine at the University of North Carolina at Chapel Hill’s Thurston Arthritis Research Center, said that its overall design was “excellent,” including appropriate masking, controls, randomization, and power and sample size calculations, contributing to “the trial’s relatively positive, although still modest, results.” Dr. Nelson was not involved with the METHODS study.

Dr. Nelson

Several factors may have contributed to the study’s success, including the broader mechanism of action of methotrexate and higher dose used, Ida K. Haugen, MD, PhD, senior researcher at Diakonhjemmet Hospital’s Center for Treatment of Rheumatic and Musculoskeletal Diseases in Oslo, Norway, told this news organization.

She noted that the MTX 20 mg/week dosage is similar to what is used in treatment of RA and may be key to better targeting inflammation.

Nicolas Tourrenc

“Furthermore, the study included individuals with hand OA and synovitis by MRI, and thus may have found the right patient population in comparison to prior studies,” Dr. Haugen said.

Dr. Cicuttini agreed, noting that “previous trials [of MTX] did not target the inflammatory phenotype of hand osteoarthritis that would be expected to respond.” In the previous randomized controlled trial of MTX in hand OA, only 29 of a total 1024 joints had synovitis, she explained. “Their inclusion criteria were individuals with severe erosive hand osteoarthritis, suggesting that this later-stage disease is less likely to respond.”

Dr. Cicuttini said that she saw no specific issues in regard to potential use of MTX in the OA population in the clinic. “The data we have, together with the large experience we have with using methotrexate and the fact that treatments for hand OA are not very effective, means that it would be reasonable to offer this to patients with hand OA and inflammation,” she said. “The level of evidence for an effect of methotrexate would need to be discussed with the patient. The discussion around the use of methotrexate would then need to proceed in the same way we discuss the use of methotrexate with patients when used for other inflammatory joint diseases, and the decision is then made with the patient.”

In contrast, Dr. Nelson expressed some concerns regarding the immediate use of MTX for this population. “Many individuals with hand OA have multiple medical comorbidities and polypharmacy, which are important when considering additional treatments, particularly those with modest benefit and potential adverse effects over the long term,” she said. “I do not think this single study provides enough evidence to suggest that all such patients should be treated with methotrexate, and more data, particularly about long-term use and optimal risk stratification, is needed.” 

While MTX use in refractory inflammatory hand OA is not yet recommended in international guidelines, Dr. Haugen believes this study supports use of MTX in this patient population. Given that MRI and ultrasound may not always be available to identify synovitis, Dr. Nelson and Dr. Haugen suggested identifying patients who may benefit through careful history and clinical examination for evidence of swollen joints. In addition, Dr. Cicuttini explained that she would not necessarily use MTX in patients with erosive OA radiographically because it may be a later stage of disease that is less likely to respond.

The authors highlighted potential limitations of the METHODS trial. They initially planned to study whether MTX reduced pain and improved radiographic progression at 2 years, but since they paused the study for 7 months during the COVID-19 pandemic, they amended the trial protocol and focused on pain reduction at 6 months as the primary endpoint instead.

Tender and swollen joint counts were initially going to be included, but this was modified given the use of virtual telemedicine visits during the pandemic. Dr. Cicuttini said that further studies are underway to identify potential subpopulations who may benefit from immunosuppression, and others are needed to determine whether MTX reduces joint damage and slows disease progression in hand OA with inflammation.

Dr. Cicuttini said her research group is interested to see whether women who develop hand OA around the time of menopause (“menopausal OA”) are a group that could benefit. Dr. Haugen noted that she is involved in a study testing MTX in erosive hand OA (the MERINO trial). 

The study was funded by a project grant from the National Health and Medical Research Council of Australia. The authors reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

Key abstracts on multiple sclerosis treatment from the 2023 European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting are reported by Dr Ellen Mowry of Johns Hopkins University.

Dr Mowry begins with a convenient alternative method of drug administration in patients with multiple sclerosis (MS). The phase 3 OCARINA II randomized trial showed promising results in safety and efficacy of subcutaneous ocrelizumab vs traditional longer intravenous infusion. Ocrelizumab is pending US Food and Drug Administration approval.

Next, Dr Mowry highlights two studies that examined known increased risks associated with anti-CD20 therapies. Dr Mowry discusses the importance of continued research into monitoring immunoglobin levels to determine dose escalation or extended interval dosing in patients with MS.

She then discusses the NEXT MS trial that looked at personalized dosing of natalizumab. The interim data indicate a dosing schedule that aims to maintain blood levels of the drug above a certain threshold appears as effective in controlling disease activity in relapsing-remitting MS (RRMS) as the approved 4-week dosing schedule.

Finally, Dr Mowry discusses a phase 2 randomized trial of the gold nanoparticle CNM-Au8, which has been used to treat other autoimmune diseases, to determine its potential benefits in RRMS.

--

Ellen Mowry, MD, MCR, Professor of Neurology & Epidemiology, Johns Hopkins University, Baltimore, Maryland

Ellen Mowry, MD, MCR, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: BeCareLink, LLC

Received research grant from: Biogen; Genentech

Received royalties from: UpToDate

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Treatment with two naturally occurring psychedelics was associated with reduced depressive and anxiety symptoms in trauma-exposed U.S. Special Operations Forces Veterans (SOFVs), according to a new study. Perhaps most surprising to investigators, however, was that treatment was also associated with improved cognitive scores in the veterans, many of whom had traumatic brain injuries.

METHODOLOGY:

• Investigators reviewed clinical charts of 86 SOFVs who received psychedelic-assisted treatment at a therapeutic program in Mexico, 86% of whom sustained head injuries during deployment.
• On the first day of the study, participants received a single oral dose (10 mg/kg) of ibogaine hydrochloride in a group setting with two to five other attendees and spent the next day reflecting on their experience with program staff.
• On the third day, participants inhaled 5-MeO-DMT in three incremental doses for a total of 50 mg and were then invited to reflect on their experience both individually and with the group of peers who shared the experience.
• Follow-up surveys at 1, 3, and 6 months posttreatment between September 2019 to March 2021 measured symptoms of posttraumatic stress disorder, cognitive functioning, generalized anxiety disorder, depression, and quality of life.

TAKEAWAY:

• There were significant improvements in self-reported PTSD symptoms, depression, anxiety, insomnia severity, anger, and a large improvement in self-reported satisfaction with life (P < .001 for all).
• Participants reported significant increases in psychological flexibility (P < .001), cognitive functioning (P < .001), and postconcussive symptoms (P < .001).
• Treatment was also associated with a significant reduction in suicidal ideation from pretreatment to 1-month follow-up (P < .01).

IN PRACTICE:

“If consistently replicated, this could have major implications for the landscape of mental health care if people are able to experience significant and sustained healing with 3 days of intensive treatment, relative to our traditionally available interventions that require 8-12 weeks of weekly therapy (for example, gold standard talk therapies such as [prolonged exposure] or [cognitive processing therapy]), or daily use of a pharmacotherapy such as [a selective serotonin reuptake inhibitor] for months to years,” study authors write.

SOURCE:

Alan Kooi Davis, PhD, of the Center for Psychedelic Drug Research and Education at Ohio State University, led the study, which was published online  in the American Journal of Drug and Alcohol Abuse.

LIMITATIONS:

Study assessments are based solely on self-report measures. Future research should implement carefully designed batteries that include both self-report and gold-standard clinician-administered measures to better capture symptom improvement and other information. The sample also lacked diversity with regard to race, religion, and socioeconomic status.

DISCLOSURES:

The study was funded by Veterans Exploring Treatment Solutions. Dr. Davis is a board member at Source Resource Foundation and a lead trainer at Fluence. Full disclosures are included in the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

New research suggests that long-term exposure to air pollution during and after pregnancy increases the risk of postpartum depression (PPD), adding to prior research linking air pollution to mental health issues.

METHODOLOGY:

• Researchers analyzed data on 340,679 women who had singleton live births at Kaiser Permanente Southern California facilities between 2008 and 2016.
• Ambient air pollution exposures were assessed based on maternal residential addresses using monthly averages of particulate matter ≤ 2.5 mcm (PM_2.5), PM ≤ 10 mcm (PM₁₀), nitrogen dioxide, and ozone from Environmental Protection Agency monitoring stations.
• Constituents of PM_2.5 (sulfate, nitrate, ammonium, organic matter, and black carbon) were obtained from models based on satellite, ground-based monitor, and chemical transport modeling data.
• Women with an Edinburgh Postnatal Depression Scale score of at least 10 during the first 6 months postpartum were referred for further assessment, including diagnosis and treatment.

TAKEAWAY:

• A total of 25,674 women had PPD (7.5%).
• Positive associations were observed between PPD ozone (adjusted odds ratio, 1.09), PM₁₀ (aOR, 1.02), and PM_2.5 (aOR, 1.02), with no statistically significant association with nitrogen dioxide.
• Among PM_2.5 constituents, black carbon had the strongest association with PPD (OR 1.04).
• Overall, a higher risk of PPD was associated with ozone exposure during the entire pregnancy and postpartum periods and with PM exposure during the late pregnancy and postpartum periods.

IN PRACTICE:

“These findings suggest that long-term antepartum and postpartum air pollution exposure is a potentially modifiable environmental risk factor for PPD and an important public health issue to address for improved maternal mental health,” the authors wrote.

SOURCE:

The study, with first author Yi Sun, PhD, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, was published online in JAMA Network Open.

LIMITATIONS:

Postpartum exposures were estimated using only maternal address at delivery, which may have led to exposure misclassification. Potential exposure misclassifications may also exist since indoor and personal exposure levels could not be estimated. Although several covariates were adjusted for, some residual or unmeasured covariates were inevitable due to data unavailability, such as psychiatric history, adverse life events, and marital status, which may affect mental health.

DISCLOSURES:

This study was supported by a grant from the National Institute of Environmental Health Sciences. The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

A version of this article first appeared on Medscape.com.

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

A version of this article first appeared on Medscape.com.

The anti-inflammatory agent colchicine, started within 24 hours of acute ischemic stroke or a transient ischemic attack (TIA), was not associated with a reduction in subsequent strokes or other vascular events at 90 days in the CHANCE-3 trial.

The results were presented by Yongjun Wang, MD, Beijing Tiantan Hospital, Capital Medical University, at the annual World Stroke Congress, sponsored by the World Stroke Organization.

Dr. Wang noted that inflammation may be a key factor involved in the residual risk for recurrent stroke, with data from previous CHANCE trials suggesting a higher stroke recurrence rate in patients with higher levels of high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation.

Low-dose colchicine, which acts as an anti-inflammatory agent, has recently been approved in many countries for patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease to reduce the risk for future cardiovascular events. This follows benefits seen in those populations in the LoDoCo-2 and COLCOT trials.

The CHANCE-3 study was conducted to evaluate whether similar benefits could be found in patients with acute ischemic stroke.

The trial involved 8,369 Chinese patients with minor to moderate ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk TIA (ABCD2 score ≥ 4) who had an hsCRP level of at least 2 mg/L.

Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or placebo, on a background of optimal medical therapy.

The primary outcome was any stroke within 90 days. The key secondary outcomes included a composite of stroke, TIA, myocardial infarction, and vascular death within 90 days, and Modified Rankin Scale score greater than 1 at 90 days.

Results showed that the primary outcome of any stroke at 90 days occurred in 6.3% of the colchicine group versus 6.5% of the placebo group, a nonsignificant difference (P = .79).

All secondary outcomes were also neutral, with no differences between the two groups.

Addressing the different results in CHANCE-3, compared with those of the cardiovascular trials of colchicine, Dr. Wang pointed out that the cardiovascular trials had a much longer treatment and follow-up time (an average of 22 months), compared with just 3 months in CHANCE-3.

“Clinical trials with longer treatment times are needed to further assess the effects of colchicine after cerebrovascular events, but it may be that ischemic cerebrovascular disease and ischemic heart disease respond differently to colchicine treatment,” he concluded.

Commenting on the study, cochair of the WSC session at which it was presented, Ashkan Shoamanesh, MD, associate professor of medicine at McMaster University, Hamilton, Ont., said CHANCE-3 was a well-designed large phase 3 randomized trial and the first such trial to test colchicine for secondary stroke prevention. 

He agreed with Dr. Wang that the follow-up duration for this initial analysis of 3-month outcomes may have been too short to see an effect.

“So, we require randomized trials with longer follow-up prior to abandoning this potential treatment,” he added. 

Dr. Shoamanesh noted that several additional trials are currently ongoing testing colchicine for secondary prevention in patients with stroke. These include the CONVINCE, CASPER, CoVasc-ICH, and RIISC-THETIS trials.

He also pointed out that, in contrast to ischemic heart disease, which results from atherosclerosis, the mechanisms underlying ischemic stroke are more heterogeneous and include various vascular and cardioembolic pathologies.

The CHANCE-3 study was funded by grants from the National Natural Science Foundation of China, the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Health Commission.

A version of this article first appeared on Medscape.com.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

WASHINGTON – Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

WASHINGTON – Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

WASHINGTON – Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.