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Nonstimulants: A better option for ADHD?
.
Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.
Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.
In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.
“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
Nonstimulant treatment options
Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”
Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.
Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.
Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.
However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.
There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.
“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.
The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.
The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.
Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.
At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
‘Paradigm shift’
At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).
Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).
By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.
Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.
Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.
“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”
The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
Real-world study
Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”
This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.
“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.
“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.
A version of this article first appeared on Medscape.com.
.
Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.
Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.
In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.
“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
Nonstimulant treatment options
Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”
Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.
Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.
Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.
However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.
There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.
“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.
The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.
The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.
Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.
At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
‘Paradigm shift’
At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).
Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).
By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.
Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.
Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.
“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”
The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
Real-world study
Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”
This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.
“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.
“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.
A version of this article first appeared on Medscape.com.
.
Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.
Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.
In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.
“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
Nonstimulant treatment options
Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”
Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.
Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.
Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.
However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.
There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.
“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.
The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.
The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.
Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.
At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
‘Paradigm shift’
At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).
Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).
By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.
Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.
Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.
“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”
The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
Real-world study
Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”
This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.
“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.
“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.
A version of this article first appeared on Medscape.com.
FROM CNS DRUGS
FDA approves cantharidin for molluscum contagiosum
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
Serum neutrophil gelatinase-associated lipocalin levels show no correlation with PsA outcomes
Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).
Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).
Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.
Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.
Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.
Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).
Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).
Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.
Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.
Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.
Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).
Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).
Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.
Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.
Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.
Clinical and laboratory biomarkers that may help early PsA diagnosis
Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).
Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).
Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.
Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).
Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).
Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.
Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).
Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).
Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.
Real-world study highlights heterogeneity of disease domains in PsA
Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.
Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.
Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.
Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.
Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.
Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.
Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.
Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.
Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.
Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.
Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.
Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.
Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.
Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.
Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.
Increased prevalence of subclinical myocardial dysfunction in PsA with higher disease activity
Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.
Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.
Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.
Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.
Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.
Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.
Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.
Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.
Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.
Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.
Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.
Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.
Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.
Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.
Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.
Anti-TNF-α therapy reduces incidence of nailfold capillaroscopic abnormalities in PsA
Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.
Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).
Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.
Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.
Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).
Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.
Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.
Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).
Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.
Improvement in patient-reported outcomes comparable with ustekinumab and TNFi in PsA
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Apremilast offers a safe long-term oral treatment option for psoriatic arthritis
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Real-world study confirms clinical efficacy of ixekizumab in PsA
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.