Pregnant women with PsA at risk for adverse maternal outcomes

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Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

 

 

 

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Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

 

 

 

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

 

 

 

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Tender joints in active PsA poorly reflect inflammation indicated by ultrasound and MRI

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Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, 0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

 

 

 

 

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Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, 0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

 

 

 

 

Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, 0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

 

 

 

 

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Once-weekly oral antipsychotic for schizophrenia on the horizon

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A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

Dr. David Walling

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

 

 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

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

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A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

Dr. David Walling

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

 

 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

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

A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

Dr. David Walling

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

 

 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

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

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PsA tied with higher prevalence of coronary calcification

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Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.

 

 

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Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.

 

 

Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.

 

 

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PsA: Rates of hospitalized serious infections lower with ustekinumab vs. other biologics

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Key clinical point: In patients with psoriasis or psoriatic arthritis (PsA), the risk for hospitalized serious infection was lower among those who initiated ustekinumab than other biologics and apremilast.

Major finding: Compared with ustekinumab, the risk for hospitalized serious infection was higher for adalimumab (combined weighted hazard ratio [HR], 1.66; 95% confidence interval [CI], 1.34-2.06), apremilast (HR, 1.42; 95% CI, 1.02-1.96), certolizumab (HR, 1.09; 95% CI, 0.68-1.75), etanercept (HR, 1.39; 95% CI, 1.01-1.90), golimumab (HR, 1.74; 95% CI, 1.00-3.03), infliximab (HR, 2.92; 95% CI, 1.80-4.72), ixekizumab (HR, 2.98; 95% CI, 1.20-7.41), and secukinumab (HR, 1.84; 95% CI, 1.24-2.72).

Study details: Findings are from a population-based cohort study of 123,383 patients with psoriasis/PsA who initiated 1 among ustekinumab, adalimumab, apremilast, certolizumab, etanercept, golimumab, ixekizumab, or secukinumab between 2009 and 2018.

Disclosures: This study was sponsored by the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. SC Kim, RJ Desai, and JF Merola reported receiving research grants from and/or working as consultants/investigators for various sources. The remaining authors declared no conflicts of interest.

Source: Jin Y et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24630.

 

 

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Key clinical point: In patients with psoriasis or psoriatic arthritis (PsA), the risk for hospitalized serious infection was lower among those who initiated ustekinumab than other biologics and apremilast.

Major finding: Compared with ustekinumab, the risk for hospitalized serious infection was higher for adalimumab (combined weighted hazard ratio [HR], 1.66; 95% confidence interval [CI], 1.34-2.06), apremilast (HR, 1.42; 95% CI, 1.02-1.96), certolizumab (HR, 1.09; 95% CI, 0.68-1.75), etanercept (HR, 1.39; 95% CI, 1.01-1.90), golimumab (HR, 1.74; 95% CI, 1.00-3.03), infliximab (HR, 2.92; 95% CI, 1.80-4.72), ixekizumab (HR, 2.98; 95% CI, 1.20-7.41), and secukinumab (HR, 1.84; 95% CI, 1.24-2.72).

Study details: Findings are from a population-based cohort study of 123,383 patients with psoriasis/PsA who initiated 1 among ustekinumab, adalimumab, apremilast, certolizumab, etanercept, golimumab, ixekizumab, or secukinumab between 2009 and 2018.

Disclosures: This study was sponsored by the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. SC Kim, RJ Desai, and JF Merola reported receiving research grants from and/or working as consultants/investigators for various sources. The remaining authors declared no conflicts of interest.

Source: Jin Y et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24630.

 

 

Key clinical point: In patients with psoriasis or psoriatic arthritis (PsA), the risk for hospitalized serious infection was lower among those who initiated ustekinumab than other biologics and apremilast.

Major finding: Compared with ustekinumab, the risk for hospitalized serious infection was higher for adalimumab (combined weighted hazard ratio [HR], 1.66; 95% confidence interval [CI], 1.34-2.06), apremilast (HR, 1.42; 95% CI, 1.02-1.96), certolizumab (HR, 1.09; 95% CI, 0.68-1.75), etanercept (HR, 1.39; 95% CI, 1.01-1.90), golimumab (HR, 1.74; 95% CI, 1.00-3.03), infliximab (HR, 2.92; 95% CI, 1.80-4.72), ixekizumab (HR, 2.98; 95% CI, 1.20-7.41), and secukinumab (HR, 1.84; 95% CI, 1.24-2.72).

Study details: Findings are from a population-based cohort study of 123,383 patients with psoriasis/PsA who initiated 1 among ustekinumab, adalimumab, apremilast, certolizumab, etanercept, golimumab, ixekizumab, or secukinumab between 2009 and 2018.

Disclosures: This study was sponsored by the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. SC Kim, RJ Desai, and JF Merola reported receiving research grants from and/or working as consultants/investigators for various sources. The remaining authors declared no conflicts of interest.

Source: Jin Y et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24630.

 

 

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PsA: Swapping biologics gives no remarkable advantage over cycling

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Key clinical point: In a real-life cohort of patients with psoriatic arthritis (PsA), using drugs with the same (cycling) mode of action (MoA) after the failure of the previous one was not remarkably better than using the drug with a different MoA (swapping) than the previously failed drug.

Major finding: Drug retention rate was not significantly different between the group that underwent swapping vs. cycling (hazard ratio [HR] 0.95; 95% confidence interval [CI], 0.52-1.74), and effectiveness of swapping was not different from that observed in the first-line prescription group (HR, 1.45; 95% CI, 0.83-2.52).

Study details: This was a monocentric medical records review study of 183 patients with PsA treated with biologic disease-modifying antirheumatic drugs (DMARDs) or targeted synthetic DMARDs. The medical records were grouped into cycling, swapping, or first-line groups.

Disclosures: The authors did not identify any source of funding. The authors declared no conflicts of interest.

Source: Ariani A et al. Medicine (Baltimore). 2021 Apr 23. doi: 10.1097/MD.0000000000025300.

 

 

 

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Key clinical point: In a real-life cohort of patients with psoriatic arthritis (PsA), using drugs with the same (cycling) mode of action (MoA) after the failure of the previous one was not remarkably better than using the drug with a different MoA (swapping) than the previously failed drug.

Major finding: Drug retention rate was not significantly different between the group that underwent swapping vs. cycling (hazard ratio [HR] 0.95; 95% confidence interval [CI], 0.52-1.74), and effectiveness of swapping was not different from that observed in the first-line prescription group (HR, 1.45; 95% CI, 0.83-2.52).

Study details: This was a monocentric medical records review study of 183 patients with PsA treated with biologic disease-modifying antirheumatic drugs (DMARDs) or targeted synthetic DMARDs. The medical records were grouped into cycling, swapping, or first-line groups.

Disclosures: The authors did not identify any source of funding. The authors declared no conflicts of interest.

Source: Ariani A et al. Medicine (Baltimore). 2021 Apr 23. doi: 10.1097/MD.0000000000025300.

 

 

 

Key clinical point: In a real-life cohort of patients with psoriatic arthritis (PsA), using drugs with the same (cycling) mode of action (MoA) after the failure of the previous one was not remarkably better than using the drug with a different MoA (swapping) than the previously failed drug.

Major finding: Drug retention rate was not significantly different between the group that underwent swapping vs. cycling (hazard ratio [HR] 0.95; 95% confidence interval [CI], 0.52-1.74), and effectiveness of swapping was not different from that observed in the first-line prescription group (HR, 1.45; 95% CI, 0.83-2.52).

Study details: This was a monocentric medical records review study of 183 patients with PsA treated with biologic disease-modifying antirheumatic drugs (DMARDs) or targeted synthetic DMARDs. The medical records were grouped into cycling, swapping, or first-line groups.

Disclosures: The authors did not identify any source of funding. The authors declared no conflicts of interest.

Source: Ariani A et al. Medicine (Baltimore). 2021 Apr 23. doi: 10.1097/MD.0000000000025300.

 

 

 

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PsA: Upadacitinib shows consistent efficacy and safety in patients with inadequate response to biologics

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Key clinical point: Upadacitinib showed consistent improvement in signs and symptoms of psoriatic arthritis (PsA) with no new significant safety signals in patients with an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs).

Major finding: At 56 weeks, the proportion of patients achieving American College of Rheumatology 20/50/70 and Psoriasis Area Severity Index 75/90/100 responses was 59.7%/40.8%/24.2% and 52.3%/40.8%/26.9%, respectively, with upadacitinib 15 mg and 59.2%/38.5%/26.6% and 58.8%/47.3%/35.1%, respectively, with upadacitinib 30 mg. Improvement was consistent through the study period with both upadacitinib doses with a safety profile consistent with that known previously.

Study details: Findings are from phase 3 SELECT-PsA 2 study, involving 641 patients with PsA who had an inadequate response to at least 1 bDMARD and were randomly allocated to receive upadacitinib 15 mg, 30 mg once daily (OD), or placebo switched to upadacitinib 15 mg or 30 mg OD at week 24.

Disclosures: SELECT-PsA 2 trial was funded by AbbVie. The authors reported receiving grants/consulting fees, speaker fees from, being employees of, and stockholder from various sources including AbbVie.

Source: Mease PJ et al. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z.

 

 

 

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Key clinical point: Upadacitinib showed consistent improvement in signs and symptoms of psoriatic arthritis (PsA) with no new significant safety signals in patients with an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs).

Major finding: At 56 weeks, the proportion of patients achieving American College of Rheumatology 20/50/70 and Psoriasis Area Severity Index 75/90/100 responses was 59.7%/40.8%/24.2% and 52.3%/40.8%/26.9%, respectively, with upadacitinib 15 mg and 59.2%/38.5%/26.6% and 58.8%/47.3%/35.1%, respectively, with upadacitinib 30 mg. Improvement was consistent through the study period with both upadacitinib doses with a safety profile consistent with that known previously.

Study details: Findings are from phase 3 SELECT-PsA 2 study, involving 641 patients with PsA who had an inadequate response to at least 1 bDMARD and were randomly allocated to receive upadacitinib 15 mg, 30 mg once daily (OD), or placebo switched to upadacitinib 15 mg or 30 mg OD at week 24.

Disclosures: SELECT-PsA 2 trial was funded by AbbVie. The authors reported receiving grants/consulting fees, speaker fees from, being employees of, and stockholder from various sources including AbbVie.

Source: Mease PJ et al. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z.

 

 

 

Key clinical point: Upadacitinib showed consistent improvement in signs and symptoms of psoriatic arthritis (PsA) with no new significant safety signals in patients with an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs).

Major finding: At 56 weeks, the proportion of patients achieving American College of Rheumatology 20/50/70 and Psoriasis Area Severity Index 75/90/100 responses was 59.7%/40.8%/24.2% and 52.3%/40.8%/26.9%, respectively, with upadacitinib 15 mg and 59.2%/38.5%/26.6% and 58.8%/47.3%/35.1%, respectively, with upadacitinib 30 mg. Improvement was consistent through the study period with both upadacitinib doses with a safety profile consistent with that known previously.

Study details: Findings are from phase 3 SELECT-PsA 2 study, involving 641 patients with PsA who had an inadequate response to at least 1 bDMARD and were randomly allocated to receive upadacitinib 15 mg, 30 mg once daily (OD), or placebo switched to upadacitinib 15 mg or 30 mg OD at week 24.

Disclosures: SELECT-PsA 2 trial was funded by AbbVie. The authors reported receiving grants/consulting fees, speaker fees from, being employees of, and stockholder from various sources including AbbVie.

Source: Mease PJ et al. Rheumatol Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z.

 

 

 

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PsA: No substantial change in body composition with ustekinumab treatment

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Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

 

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Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

 

Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

 

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ASCO 2021: Breast cancer sessions not to miss

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This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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

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This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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

This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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

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Secukinumab, a comprehensive biologic treatment for management of concomitant PsA and psoriasis

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Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

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Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

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