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FDA approves new formulation of Hyrimoz adalimumab biosimilar
The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.
Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.
Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.
The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.
Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.
The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.
“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.
The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.
Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.
Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.
The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.
Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.
The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.
“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.
The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.
Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.
Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.
The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.
Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.
The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.
“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.
The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).
A version of this article originally appeared on Medscape.com.
New data forecast more oral PDE4 inhibitors for psoriasis
NEW ORLEANS – according to results of a phase 2 clinical trial presented as a late-breaker at the annual meeting of the American Academy of Dermatology.
The phase 2b data, which are prompting a phase 3 trial, suggest that the drug, called orismilast, “is a potential new addition to the psoriasis armamentarium,” reported Lars E. French, MD, professor and chair, department of dermatology, Ludwig Maximilian University of Munich (Germany).
At the same session, findings from another study supported off-label use of oral roflumilast (Daliresp and generic), a PDE4 inhibitor approved for severe chronic obstructive pulmonary disease (COPD). The only PDE4 inhibitors with an indication for psoriasis are roflumilast, approved as a cream (Zoryve), and apremilast (Otezla), approved as an oral therapy.
Phase 2 study of orismilast
In the orismilast trial, Dr. French attributed the efficacy observed to the potency of orismilast on the B and D subtypes of PDE4 associated with inflammation. One clue is that these specific subtypes are overly expressed in the skin of patients with either psoriasis or atopic dermatitis.
“When compared to apremilast, orismilast is at least two to fivefold more potent on all PDE4 isoforms and up to 39 times more potent on some of the PDE4 B and D isoforms,” said Dr. French, referring to preclinical findings in human whole blood and blood cells and in a mouse model of chronic inflammation.
The efficacy of orismilast in an immediate-release oral formulation was previously demonstrated in a recently published phase 2a trial, but the newest study tested a modified-release formulation of orismilast to test its potential to improve tolerability.
In the study, 202 adult patients with moderate to severe psoriasis (Psoriasis Area Severity Index [PASI] score ≥ 12) were randomly assigned to one of three doses of orismilast or to placebo. Each of the three doses – 20 mg, 30 mg, or 40 mg – were administered twice daily. The primary endpoint was change in PASI score at 16 weeks. Secondary endpoints included PASI 75 responses (signifying 75% clearance) and safety.
Relative to placebo, which was associated with a PASI improvement of 17%, all three of the tested orismilast doses were superior in a dose-dependent manner. The rates of response were 53%, 61%, and 64% for the 20-mg, 30-mg, and 40-mg twice-daily doses, respectively.
The PASI improvements were rapid, Dr. French said. At 4 weeks, PASI scores climbed from baseline by nearly 40% for those on all orismilast doses, which was more than double the improvement in the placebo group.
In the intention-to-treat analysis with missing data counted as nonresponders, the proportion of patients reaching PASI-75 scores at 16 weeks were 39%, 49%, 45%, and 17%, in the 20-mg, 30-mg, 40-mg, and placebo groups, respectively. The proportion of patients experiencing complete or near-complete skin clearance defined by a PASI 90 were 24%, 22%, 28%, and 8%, respectively.
The side-effect profile was consistent with other PDE4 inhibitors. The most common adverse events included gastrointestinal complaints, such as diarrhea and nausea, as well as headache and dizziness. But the majority of these events were of low grade, and they were largely confined to the first 4 weeks of treatment, which is a pattern reported with other PDE4 inhibitors in psoriasis and other chronic inflammatory diseases, such as COPD, according to Dr. French.
“There were no discontinuations for a treatment-related adverse event in the arms receiving either the 20-mg or the 30-mg doses,” Dr. French reported. There were only two serious adverse events, and neither were considered by trial investigators to be related to orismilast.
Based on the limited therapeutic gain but greater risk for adverse events on the 40-mg twice-daily dose, “the question is now whether to move forward with the 20-mg or the 30-mg dose,” said Dr. French, who said planning of a phase 3 trial is underway.
Phase 2 study of roflumilast
However, this was not the only set of data on an oral PDE4 inhibitor presented as a late-breaker at the AAD meeting. For clinicians looking for a more immediate and less expensive alternative to apremilast, another study indicated that off-label use of oral roflumilast is an option.
In an investigator-initiated, multicenter, double-blind, placebo-controlled trial conducted in Denmark, the rate of response to oral roflumilast at 24 weeks, including the clear or almost clear response, was on the same general order of magnitude as that seen in the orismilast study, reported Alexander Egeberg, MD, PhD, professor of dermatology, University of Copenhagen.
“At 24 weeks, 21.7% had achieved a PASI 90, and 8.7% achieved a PASI 100,” Dr. Egeberg said.
Oral roflumilast has been available for the treatment of COPD for more than 10 years and is now available in a generic formulation. This study was conducted independent of any pharmaceutical company involvement, and the high rate of response and low risk of adverse events suggests that patients can benefit from a PDE4 inhibitor in a very low-cost form.
“Generic oral roflumilast is cheaper than a Starbucks coffee,” Dr. Egeberg said.
In this trial, 46 patients were randomly assigned to placebo or to the COPD-approved roflumilast dose of 500 mcg once daily. The primary endpoint was change in PASI scores from baseline to week 12, which Dr. Egeberg pointed out is a shorter time frame than the 16 weeks more typical of psoriasis treatment studies.
At week 12, the median improvement in PASI was 34.8% in the roflumilast group versus 0% in the placebo group. Patients were then followed for an additional 12 weeks, but those randomized to placebo were switched to the active treatment. By week 24, the switch patients had largely caught up to those initiated on roflumilast for median PASI improvement (39.1% vs. 43.5%).
Similar to orismilast, roflumilast “was generally well tolerated,” Dr. Egeberg said. The adverse events were consistent with those associated with PDE4 inhibitors in previous trials, whether in psoriasis or COPD. There was only one serious adverse event, and it was not considered treatment related. Discontinuations for adverse events “were very low.”
In a population with a relatively high rate of smoking, Dr. Egeberg further reported, lung function was improved, a remark initially interpreted as a joke by some attending the presentation. However, Dr. Egeberg confirmed that lung function was monitored, and objective improvements were recorded.
By Danish law, the investigators were required to inform the manufacturers of roflumilast. Despite the results of this study, he is not aware of any plans to seek an indication for roflumilast in psoriasis, but he noted that the drug is readily available at a low price.
For those willing to offer this therapy off label, “you can start using it tomorrow if you’d like,” he said.
Dr. French reports financial relationships with Almirall, Amgen, Biotest, Galderma, Janssen Cilag, Leo Pharma, Pincell, Regeneron, UCB, and UNION Therapeutics, which provided funding for this trial. Dr. Egeberg reports financial relationships with Eli Lilly, Galderma, Janssen-Cilag, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
NEW ORLEANS – according to results of a phase 2 clinical trial presented as a late-breaker at the annual meeting of the American Academy of Dermatology.
The phase 2b data, which are prompting a phase 3 trial, suggest that the drug, called orismilast, “is a potential new addition to the psoriasis armamentarium,” reported Lars E. French, MD, professor and chair, department of dermatology, Ludwig Maximilian University of Munich (Germany).
At the same session, findings from another study supported off-label use of oral roflumilast (Daliresp and generic), a PDE4 inhibitor approved for severe chronic obstructive pulmonary disease (COPD). The only PDE4 inhibitors with an indication for psoriasis are roflumilast, approved as a cream (Zoryve), and apremilast (Otezla), approved as an oral therapy.
Phase 2 study of orismilast
In the orismilast trial, Dr. French attributed the efficacy observed to the potency of orismilast on the B and D subtypes of PDE4 associated with inflammation. One clue is that these specific subtypes are overly expressed in the skin of patients with either psoriasis or atopic dermatitis.
“When compared to apremilast, orismilast is at least two to fivefold more potent on all PDE4 isoforms and up to 39 times more potent on some of the PDE4 B and D isoforms,” said Dr. French, referring to preclinical findings in human whole blood and blood cells and in a mouse model of chronic inflammation.
The efficacy of orismilast in an immediate-release oral formulation was previously demonstrated in a recently published phase 2a trial, but the newest study tested a modified-release formulation of orismilast to test its potential to improve tolerability.
In the study, 202 adult patients with moderate to severe psoriasis (Psoriasis Area Severity Index [PASI] score ≥ 12) were randomly assigned to one of three doses of orismilast or to placebo. Each of the three doses – 20 mg, 30 mg, or 40 mg – were administered twice daily. The primary endpoint was change in PASI score at 16 weeks. Secondary endpoints included PASI 75 responses (signifying 75% clearance) and safety.
Relative to placebo, which was associated with a PASI improvement of 17%, all three of the tested orismilast doses were superior in a dose-dependent manner. The rates of response were 53%, 61%, and 64% for the 20-mg, 30-mg, and 40-mg twice-daily doses, respectively.
The PASI improvements were rapid, Dr. French said. At 4 weeks, PASI scores climbed from baseline by nearly 40% for those on all orismilast doses, which was more than double the improvement in the placebo group.
In the intention-to-treat analysis with missing data counted as nonresponders, the proportion of patients reaching PASI-75 scores at 16 weeks were 39%, 49%, 45%, and 17%, in the 20-mg, 30-mg, 40-mg, and placebo groups, respectively. The proportion of patients experiencing complete or near-complete skin clearance defined by a PASI 90 were 24%, 22%, 28%, and 8%, respectively.
The side-effect profile was consistent with other PDE4 inhibitors. The most common adverse events included gastrointestinal complaints, such as diarrhea and nausea, as well as headache and dizziness. But the majority of these events were of low grade, and they were largely confined to the first 4 weeks of treatment, which is a pattern reported with other PDE4 inhibitors in psoriasis and other chronic inflammatory diseases, such as COPD, according to Dr. French.
“There were no discontinuations for a treatment-related adverse event in the arms receiving either the 20-mg or the 30-mg doses,” Dr. French reported. There were only two serious adverse events, and neither were considered by trial investigators to be related to orismilast.
Based on the limited therapeutic gain but greater risk for adverse events on the 40-mg twice-daily dose, “the question is now whether to move forward with the 20-mg or the 30-mg dose,” said Dr. French, who said planning of a phase 3 trial is underway.
Phase 2 study of roflumilast
However, this was not the only set of data on an oral PDE4 inhibitor presented as a late-breaker at the AAD meeting. For clinicians looking for a more immediate and less expensive alternative to apremilast, another study indicated that off-label use of oral roflumilast is an option.
In an investigator-initiated, multicenter, double-blind, placebo-controlled trial conducted in Denmark, the rate of response to oral roflumilast at 24 weeks, including the clear or almost clear response, was on the same general order of magnitude as that seen in the orismilast study, reported Alexander Egeberg, MD, PhD, professor of dermatology, University of Copenhagen.
“At 24 weeks, 21.7% had achieved a PASI 90, and 8.7% achieved a PASI 100,” Dr. Egeberg said.
Oral roflumilast has been available for the treatment of COPD for more than 10 years and is now available in a generic formulation. This study was conducted independent of any pharmaceutical company involvement, and the high rate of response and low risk of adverse events suggests that patients can benefit from a PDE4 inhibitor in a very low-cost form.
“Generic oral roflumilast is cheaper than a Starbucks coffee,” Dr. Egeberg said.
In this trial, 46 patients were randomly assigned to placebo or to the COPD-approved roflumilast dose of 500 mcg once daily. The primary endpoint was change in PASI scores from baseline to week 12, which Dr. Egeberg pointed out is a shorter time frame than the 16 weeks more typical of psoriasis treatment studies.
At week 12, the median improvement in PASI was 34.8% in the roflumilast group versus 0% in the placebo group. Patients were then followed for an additional 12 weeks, but those randomized to placebo were switched to the active treatment. By week 24, the switch patients had largely caught up to those initiated on roflumilast for median PASI improvement (39.1% vs. 43.5%).
Similar to orismilast, roflumilast “was generally well tolerated,” Dr. Egeberg said. The adverse events were consistent with those associated with PDE4 inhibitors in previous trials, whether in psoriasis or COPD. There was only one serious adverse event, and it was not considered treatment related. Discontinuations for adverse events “were very low.”
In a population with a relatively high rate of smoking, Dr. Egeberg further reported, lung function was improved, a remark initially interpreted as a joke by some attending the presentation. However, Dr. Egeberg confirmed that lung function was monitored, and objective improvements were recorded.
By Danish law, the investigators were required to inform the manufacturers of roflumilast. Despite the results of this study, he is not aware of any plans to seek an indication for roflumilast in psoriasis, but he noted that the drug is readily available at a low price.
For those willing to offer this therapy off label, “you can start using it tomorrow if you’d like,” he said.
Dr. French reports financial relationships with Almirall, Amgen, Biotest, Galderma, Janssen Cilag, Leo Pharma, Pincell, Regeneron, UCB, and UNION Therapeutics, which provided funding for this trial. Dr. Egeberg reports financial relationships with Eli Lilly, Galderma, Janssen-Cilag, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
NEW ORLEANS – according to results of a phase 2 clinical trial presented as a late-breaker at the annual meeting of the American Academy of Dermatology.
The phase 2b data, which are prompting a phase 3 trial, suggest that the drug, called orismilast, “is a potential new addition to the psoriasis armamentarium,” reported Lars E. French, MD, professor and chair, department of dermatology, Ludwig Maximilian University of Munich (Germany).
At the same session, findings from another study supported off-label use of oral roflumilast (Daliresp and generic), a PDE4 inhibitor approved for severe chronic obstructive pulmonary disease (COPD). The only PDE4 inhibitors with an indication for psoriasis are roflumilast, approved as a cream (Zoryve), and apremilast (Otezla), approved as an oral therapy.
Phase 2 study of orismilast
In the orismilast trial, Dr. French attributed the efficacy observed to the potency of orismilast on the B and D subtypes of PDE4 associated with inflammation. One clue is that these specific subtypes are overly expressed in the skin of patients with either psoriasis or atopic dermatitis.
“When compared to apremilast, orismilast is at least two to fivefold more potent on all PDE4 isoforms and up to 39 times more potent on some of the PDE4 B and D isoforms,” said Dr. French, referring to preclinical findings in human whole blood and blood cells and in a mouse model of chronic inflammation.
The efficacy of orismilast in an immediate-release oral formulation was previously demonstrated in a recently published phase 2a trial, but the newest study tested a modified-release formulation of orismilast to test its potential to improve tolerability.
In the study, 202 adult patients with moderate to severe psoriasis (Psoriasis Area Severity Index [PASI] score ≥ 12) were randomly assigned to one of three doses of orismilast or to placebo. Each of the three doses – 20 mg, 30 mg, or 40 mg – were administered twice daily. The primary endpoint was change in PASI score at 16 weeks. Secondary endpoints included PASI 75 responses (signifying 75% clearance) and safety.
Relative to placebo, which was associated with a PASI improvement of 17%, all three of the tested orismilast doses were superior in a dose-dependent manner. The rates of response were 53%, 61%, and 64% for the 20-mg, 30-mg, and 40-mg twice-daily doses, respectively.
The PASI improvements were rapid, Dr. French said. At 4 weeks, PASI scores climbed from baseline by nearly 40% for those on all orismilast doses, which was more than double the improvement in the placebo group.
In the intention-to-treat analysis with missing data counted as nonresponders, the proportion of patients reaching PASI-75 scores at 16 weeks were 39%, 49%, 45%, and 17%, in the 20-mg, 30-mg, 40-mg, and placebo groups, respectively. The proportion of patients experiencing complete or near-complete skin clearance defined by a PASI 90 were 24%, 22%, 28%, and 8%, respectively.
The side-effect profile was consistent with other PDE4 inhibitors. The most common adverse events included gastrointestinal complaints, such as diarrhea and nausea, as well as headache and dizziness. But the majority of these events were of low grade, and they were largely confined to the first 4 weeks of treatment, which is a pattern reported with other PDE4 inhibitors in psoriasis and other chronic inflammatory diseases, such as COPD, according to Dr. French.
“There were no discontinuations for a treatment-related adverse event in the arms receiving either the 20-mg or the 30-mg doses,” Dr. French reported. There were only two serious adverse events, and neither were considered by trial investigators to be related to orismilast.
Based on the limited therapeutic gain but greater risk for adverse events on the 40-mg twice-daily dose, “the question is now whether to move forward with the 20-mg or the 30-mg dose,” said Dr. French, who said planning of a phase 3 trial is underway.
Phase 2 study of roflumilast
However, this was not the only set of data on an oral PDE4 inhibitor presented as a late-breaker at the AAD meeting. For clinicians looking for a more immediate and less expensive alternative to apremilast, another study indicated that off-label use of oral roflumilast is an option.
In an investigator-initiated, multicenter, double-blind, placebo-controlled trial conducted in Denmark, the rate of response to oral roflumilast at 24 weeks, including the clear or almost clear response, was on the same general order of magnitude as that seen in the orismilast study, reported Alexander Egeberg, MD, PhD, professor of dermatology, University of Copenhagen.
“At 24 weeks, 21.7% had achieved a PASI 90, and 8.7% achieved a PASI 100,” Dr. Egeberg said.
Oral roflumilast has been available for the treatment of COPD for more than 10 years and is now available in a generic formulation. This study was conducted independent of any pharmaceutical company involvement, and the high rate of response and low risk of adverse events suggests that patients can benefit from a PDE4 inhibitor in a very low-cost form.
“Generic oral roflumilast is cheaper than a Starbucks coffee,” Dr. Egeberg said.
In this trial, 46 patients were randomly assigned to placebo or to the COPD-approved roflumilast dose of 500 mcg once daily. The primary endpoint was change in PASI scores from baseline to week 12, which Dr. Egeberg pointed out is a shorter time frame than the 16 weeks more typical of psoriasis treatment studies.
At week 12, the median improvement in PASI was 34.8% in the roflumilast group versus 0% in the placebo group. Patients were then followed for an additional 12 weeks, but those randomized to placebo were switched to the active treatment. By week 24, the switch patients had largely caught up to those initiated on roflumilast for median PASI improvement (39.1% vs. 43.5%).
Similar to orismilast, roflumilast “was generally well tolerated,” Dr. Egeberg said. The adverse events were consistent with those associated with PDE4 inhibitors in previous trials, whether in psoriasis or COPD. There was only one serious adverse event, and it was not considered treatment related. Discontinuations for adverse events “were very low.”
In a population with a relatively high rate of smoking, Dr. Egeberg further reported, lung function was improved, a remark initially interpreted as a joke by some attending the presentation. However, Dr. Egeberg confirmed that lung function was monitored, and objective improvements were recorded.
By Danish law, the investigators were required to inform the manufacturers of roflumilast. Despite the results of this study, he is not aware of any plans to seek an indication for roflumilast in psoriasis, but he noted that the drug is readily available at a low price.
For those willing to offer this therapy off label, “you can start using it tomorrow if you’d like,” he said.
Dr. French reports financial relationships with Almirall, Amgen, Biotest, Galderma, Janssen Cilag, Leo Pharma, Pincell, Regeneron, UCB, and UNION Therapeutics, which provided funding for this trial. Dr. Egeberg reports financial relationships with Eli Lilly, Galderma, Janssen-Cilag, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
AT AAD 2023
Disease burden is higher in women vs men with psoriatic arthritis
Key clinical point: The psoriatic arthritis (PsA) disease burden had worse impact on women vs men with PsA, with women having a higher disease activity, worse function, and greater disease burden.
Major finding: Female vs male patients with PsA had a significantly higher mean patient global assessment score (P < .001), patient’s pain score (P = .003), tender joint count (P < .001), swollen joint count (P = .033), and Disease Activity Score for PsA (P < .001). Minimal disease activity was achieved by 44.0% of men vs 24.6% of women (P = .003).
Study details: Findings are from a cross-sectional analysis of 2 longitudinal cohorts including 141 male and 131 female patients with PsA who received treatment with conventional synthetic or biologic disease-modifying antirheumatic drugs for at least 6 months.
Disclosures: This study did not receive funding. The authors declared no conflicts of interest.
Source: Lubrano E et al. Psoriatic arthritis in males and females: Differences and similarities. Rheumatol Ther. 2023 (Feb 16). Doi: 10.1007/s40744-023-00535-3
Key clinical point: The psoriatic arthritis (PsA) disease burden had worse impact on women vs men with PsA, with women having a higher disease activity, worse function, and greater disease burden.
Major finding: Female vs male patients with PsA had a significantly higher mean patient global assessment score (P < .001), patient’s pain score (P = .003), tender joint count (P < .001), swollen joint count (P = .033), and Disease Activity Score for PsA (P < .001). Minimal disease activity was achieved by 44.0% of men vs 24.6% of women (P = .003).
Study details: Findings are from a cross-sectional analysis of 2 longitudinal cohorts including 141 male and 131 female patients with PsA who received treatment with conventional synthetic or biologic disease-modifying antirheumatic drugs for at least 6 months.
Disclosures: This study did not receive funding. The authors declared no conflicts of interest.
Source: Lubrano E et al. Psoriatic arthritis in males and females: Differences and similarities. Rheumatol Ther. 2023 (Feb 16). Doi: 10.1007/s40744-023-00535-3
Key clinical point: The psoriatic arthritis (PsA) disease burden had worse impact on women vs men with PsA, with women having a higher disease activity, worse function, and greater disease burden.
Major finding: Female vs male patients with PsA had a significantly higher mean patient global assessment score (P < .001), patient’s pain score (P = .003), tender joint count (P < .001), swollen joint count (P = .033), and Disease Activity Score for PsA (P < .001). Minimal disease activity was achieved by 44.0% of men vs 24.6% of women (P = .003).
Study details: Findings are from a cross-sectional analysis of 2 longitudinal cohorts including 141 male and 131 female patients with PsA who received treatment with conventional synthetic or biologic disease-modifying antirheumatic drugs for at least 6 months.
Disclosures: This study did not receive funding. The authors declared no conflicts of interest.
Source: Lubrano E et al. Psoriatic arthritis in males and females: Differences and similarities. Rheumatol Ther. 2023 (Feb 16). Doi: 10.1007/s40744-023-00535-3
Apremilast safe and effective in biologic-naive patients with early PsA
Key clinical point: Early initiation of apremilast led to rapid and sustained improvements in psoriatic arthritis (PsA) manifestations with a consistent safety profile in a real-world cohort of biologic-naive patients who were intolerant of conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
Major finding: Among patients with baseline swollen joint count (SJC) and tender joint count (TJC) of >0, significant median decreases in SJC (50% and 90%, respectively) and TJC (50% and 80%, respectively) were observed at 16 and 52 weeks (all P < .001), with 55.2% of evaluable patients achieving minimal disease activity at 52 weeks. Overall, 13.8% of patients experienced ≥1 adverse event, with all except one being non-serious.
Study details: This prospective study included 167 biologic-naive patients with early peripheral PsA and intolerance or inadequate response to csDMARD who initiated apremilast.
Disclosures: This study was funded by Genesis Pharma and Celgene. Some authors reported ties with various sources, including Genesis Pharma. A Kekki and N Antonakopoulos reported being employees of Genesis Pharma.
Source: Sfikakis PP et al. Apremilast for biologic-naïve, peripheral psoriatic arthritis, including patients with early disease: Results from the APROACH observational prospective study. Rheumatol Int. 2023 (Mar 1). Doi: 10.1007/s00296-022-05269-z
Key clinical point: Early initiation of apremilast led to rapid and sustained improvements in psoriatic arthritis (PsA) manifestations with a consistent safety profile in a real-world cohort of biologic-naive patients who were intolerant of conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
Major finding: Among patients with baseline swollen joint count (SJC) and tender joint count (TJC) of >0, significant median decreases in SJC (50% and 90%, respectively) and TJC (50% and 80%, respectively) were observed at 16 and 52 weeks (all P < .001), with 55.2% of evaluable patients achieving minimal disease activity at 52 weeks. Overall, 13.8% of patients experienced ≥1 adverse event, with all except one being non-serious.
Study details: This prospective study included 167 biologic-naive patients with early peripheral PsA and intolerance or inadequate response to csDMARD who initiated apremilast.
Disclosures: This study was funded by Genesis Pharma and Celgene. Some authors reported ties with various sources, including Genesis Pharma. A Kekki and N Antonakopoulos reported being employees of Genesis Pharma.
Source: Sfikakis PP et al. Apremilast for biologic-naïve, peripheral psoriatic arthritis, including patients with early disease: Results from the APROACH observational prospective study. Rheumatol Int. 2023 (Mar 1). Doi: 10.1007/s00296-022-05269-z
Key clinical point: Early initiation of apremilast led to rapid and sustained improvements in psoriatic arthritis (PsA) manifestations with a consistent safety profile in a real-world cohort of biologic-naive patients who were intolerant of conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
Major finding: Among patients with baseline swollen joint count (SJC) and tender joint count (TJC) of >0, significant median decreases in SJC (50% and 90%, respectively) and TJC (50% and 80%, respectively) were observed at 16 and 52 weeks (all P < .001), with 55.2% of evaluable patients achieving minimal disease activity at 52 weeks. Overall, 13.8% of patients experienced ≥1 adverse event, with all except one being non-serious.
Study details: This prospective study included 167 biologic-naive patients with early peripheral PsA and intolerance or inadequate response to csDMARD who initiated apremilast.
Disclosures: This study was funded by Genesis Pharma and Celgene. Some authors reported ties with various sources, including Genesis Pharma. A Kekki and N Antonakopoulos reported being employees of Genesis Pharma.
Source: Sfikakis PP et al. Apremilast for biologic-naïve, peripheral psoriatic arthritis, including patients with early disease: Results from the APROACH observational prospective study. Rheumatol Int. 2023 (Mar 1). Doi: 10.1007/s00296-022-05269-z
Concurrent onset of skin and joint symptoms tied to high disease activity in PsA
Key clinical point: Concurrent onset of skin lesions and joint symptoms increased the likelihood of moderate or high disease activity in patients with psoriatic arthritis (PsA), highlighting the importance of sequence in which skin and joint symptoms appear in disease management.
Major finding: Patients with concurrent onset of skin and joint symptoms (adjusted odds ratio 4.65; P = .007) were more likely to have a moderate or high disease activity (Psoriatic Arthritis Disease Activity Score >3.2).
Study details: Findings are from a retrospective cross-sectional study including 286 patients with PsA.
Disclosures: This study was funded by the National Natural Science Foundation of China. No conflicts of interest were declared.
Source: Tan M et al. Concurrent onset of skin and joint symptoms correlates with higher psoriatic arthritis disease activity: A single-center retrospective study. J Am Acad Dermatol. 2023 (Mar 6). Doi: 10.1016/j.jaad.2023.02.045
Key clinical point: Concurrent onset of skin lesions and joint symptoms increased the likelihood of moderate or high disease activity in patients with psoriatic arthritis (PsA), highlighting the importance of sequence in which skin and joint symptoms appear in disease management.
Major finding: Patients with concurrent onset of skin and joint symptoms (adjusted odds ratio 4.65; P = .007) were more likely to have a moderate or high disease activity (Psoriatic Arthritis Disease Activity Score >3.2).
Study details: Findings are from a retrospective cross-sectional study including 286 patients with PsA.
Disclosures: This study was funded by the National Natural Science Foundation of China. No conflicts of interest were declared.
Source: Tan M et al. Concurrent onset of skin and joint symptoms correlates with higher psoriatic arthritis disease activity: A single-center retrospective study. J Am Acad Dermatol. 2023 (Mar 6). Doi: 10.1016/j.jaad.2023.02.045
Key clinical point: Concurrent onset of skin lesions and joint symptoms increased the likelihood of moderate or high disease activity in patients with psoriatic arthritis (PsA), highlighting the importance of sequence in which skin and joint symptoms appear in disease management.
Major finding: Patients with concurrent onset of skin and joint symptoms (adjusted odds ratio 4.65; P = .007) were more likely to have a moderate or high disease activity (Psoriatic Arthritis Disease Activity Score >3.2).
Study details: Findings are from a retrospective cross-sectional study including 286 patients with PsA.
Disclosures: This study was funded by the National Natural Science Foundation of China. No conflicts of interest were declared.
Source: Tan M et al. Concurrent onset of skin and joint symptoms correlates with higher psoriatic arthritis disease activity: A single-center retrospective study. J Am Acad Dermatol. 2023 (Mar 6). Doi: 10.1016/j.jaad.2023.02.045
Ultrasound helps screen patients with moderate-to-severe psoriasis progressing to subclinical PsA
Key clinical point: In patients with moderate-to-severe psoriasis, the presence of synovio-enthesitis on ultrasound, particularly in lower limbs, indicated progression to subclinical psoriatic arthritis (PsA). Therefore, routine ultrasound screening should be performed irrespective of arthritis symptoms.
Major finding: Only synovio-enthesitis diagnosis differed significantly among patients with silent psoriasis vs control individuals (16.1% vs 1.3%; P < .001), with 12.7% of patients diagnosed with synovio-enthesitis progressing to subclinical PsA and the top four sites with synovio-enthesitis involvement being in lower limbs. Body surface area and Psoriasis Area and Severity Index scores were not different in psoriasis, subclinical PsA, and prodromal/active PsA phases.
Study details: This cross-sectional study included 490 patients with moderate-to-severe psoriasis, of which 384 and 106 patients without and with arthritis symptoms formed the silent psoriasis and clinical PsA groups, respectively, and 80 age- and sex-matched control individuals without psoriasis.
Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Chen ZT et al. The role of ultrasound in screening subclinical psoriatic arthritis in patients with moderate to severe psoriasis. Eur Radiol. 2023 (Feb 28). Doi: 10.1007/s00330-023-09493-4
Key clinical point: In patients with moderate-to-severe psoriasis, the presence of synovio-enthesitis on ultrasound, particularly in lower limbs, indicated progression to subclinical psoriatic arthritis (PsA). Therefore, routine ultrasound screening should be performed irrespective of arthritis symptoms.
Major finding: Only synovio-enthesitis diagnosis differed significantly among patients with silent psoriasis vs control individuals (16.1% vs 1.3%; P < .001), with 12.7% of patients diagnosed with synovio-enthesitis progressing to subclinical PsA and the top four sites with synovio-enthesitis involvement being in lower limbs. Body surface area and Psoriasis Area and Severity Index scores were not different in psoriasis, subclinical PsA, and prodromal/active PsA phases.
Study details: This cross-sectional study included 490 patients with moderate-to-severe psoriasis, of which 384 and 106 patients without and with arthritis symptoms formed the silent psoriasis and clinical PsA groups, respectively, and 80 age- and sex-matched control individuals without psoriasis.
Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Chen ZT et al. The role of ultrasound in screening subclinical psoriatic arthritis in patients with moderate to severe psoriasis. Eur Radiol. 2023 (Feb 28). Doi: 10.1007/s00330-023-09493-4
Key clinical point: In patients with moderate-to-severe psoriasis, the presence of synovio-enthesitis on ultrasound, particularly in lower limbs, indicated progression to subclinical psoriatic arthritis (PsA). Therefore, routine ultrasound screening should be performed irrespective of arthritis symptoms.
Major finding: Only synovio-enthesitis diagnosis differed significantly among patients with silent psoriasis vs control individuals (16.1% vs 1.3%; P < .001), with 12.7% of patients diagnosed with synovio-enthesitis progressing to subclinical PsA and the top four sites with synovio-enthesitis involvement being in lower limbs. Body surface area and Psoriasis Area and Severity Index scores were not different in psoriasis, subclinical PsA, and prodromal/active PsA phases.
Study details: This cross-sectional study included 490 patients with moderate-to-severe psoriasis, of which 384 and 106 patients without and with arthritis symptoms formed the silent psoriasis and clinical PsA groups, respectively, and 80 age- and sex-matched control individuals without psoriasis.
Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Chen ZT et al. The role of ultrasound in screening subclinical psoriatic arthritis in patients with moderate to severe psoriasis. Eur Radiol. 2023 (Feb 28). Doi: 10.1007/s00330-023-09493-4
Real world study finds no evidence of increased cancer risk with JAKi vs TNFi in PsA
Key clinical point: The short-term risk for cancer other than non-melanoma skin cancer (NMSC) or NMSC was not significantly higher among patients with psoriatic arthritis (PsA) who initiated Janus kinase inhibitors (JAKi) than those who initiated tumor necrosis factor inhibitors (TNFi).
Major finding: JAKi vs TNFi was not significantly associated with a higher risk for cancer other than NMSC (adjusted hazard ratio [aHR] 1.88; 95% CI 0.68-5.16) or NMSC (aHR 2.05; 95% CI 0.79-5.31) in patients with PsA.
Study details: The data come from an observational cohort study that evaluated prospectively collected data of 4443 patients with PsA and 10,447 patients with RA, all without previous cancer, who received JAKi, TNFi, or other non-TNFi biologic disease-modifying antirheumatic drugs.
Disclosures: This study was funded by the Karolinska Institute Region Stockholm funds (ALF), Swedish Research Council, and others. T Frisell and H Bower declared being partly employed by the ARTIS project. J Askling reported research agreements with various sources.
Source: Huss V et al on behalf of the ARTIS group. Cancer risks with JAKi and biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis: A national real-world cohort study. Ann Rheum Dis. 2023 (Mar 3). Doi: 10.1136/ard-2022-223636
Key clinical point: The short-term risk for cancer other than non-melanoma skin cancer (NMSC) or NMSC was not significantly higher among patients with psoriatic arthritis (PsA) who initiated Janus kinase inhibitors (JAKi) than those who initiated tumor necrosis factor inhibitors (TNFi).
Major finding: JAKi vs TNFi was not significantly associated with a higher risk for cancer other than NMSC (adjusted hazard ratio [aHR] 1.88; 95% CI 0.68-5.16) or NMSC (aHR 2.05; 95% CI 0.79-5.31) in patients with PsA.
Study details: The data come from an observational cohort study that evaluated prospectively collected data of 4443 patients with PsA and 10,447 patients with RA, all without previous cancer, who received JAKi, TNFi, or other non-TNFi biologic disease-modifying antirheumatic drugs.
Disclosures: This study was funded by the Karolinska Institute Region Stockholm funds (ALF), Swedish Research Council, and others. T Frisell and H Bower declared being partly employed by the ARTIS project. J Askling reported research agreements with various sources.
Source: Huss V et al on behalf of the ARTIS group. Cancer risks with JAKi and biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis: A national real-world cohort study. Ann Rheum Dis. 2023 (Mar 3). Doi: 10.1136/ard-2022-223636
Key clinical point: The short-term risk for cancer other than non-melanoma skin cancer (NMSC) or NMSC was not significantly higher among patients with psoriatic arthritis (PsA) who initiated Janus kinase inhibitors (JAKi) than those who initiated tumor necrosis factor inhibitors (TNFi).
Major finding: JAKi vs TNFi was not significantly associated with a higher risk for cancer other than NMSC (adjusted hazard ratio [aHR] 1.88; 95% CI 0.68-5.16) or NMSC (aHR 2.05; 95% CI 0.79-5.31) in patients with PsA.
Study details: The data come from an observational cohort study that evaluated prospectively collected data of 4443 patients with PsA and 10,447 patients with RA, all without previous cancer, who received JAKi, TNFi, or other non-TNFi biologic disease-modifying antirheumatic drugs.
Disclosures: This study was funded by the Karolinska Institute Region Stockholm funds (ALF), Swedish Research Council, and others. T Frisell and H Bower declared being partly employed by the ARTIS project. J Askling reported research agreements with various sources.
Source: Huss V et al on behalf of the ARTIS group. Cancer risks with JAKi and biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis: A national real-world cohort study. Ann Rheum Dis. 2023 (Mar 3). Doi: 10.1136/ard-2022-223636
JAKi effective for PsA but higher doses may have increased toxicity
Key clinical point: All Janus kinase inhibitors (JAKi) were more effective than placebo in patients with psoriatic arthritis (PsA), but led to a higher overall incidence of adverse events, particularly at higher doses.
Major finding: JAKi vs placebo were associated with a significantly higher American College of Rheumatology 20 response rate (relative risk [RR] 2.09; P < .00001), with the response being the highest for filgotinib (RR 2.40; P < .00001), followed by upadacitinib, tofacitinib, and deucravacitinib. However, the overall incidence of adverse events was higher with JAKi vs placebo (RR 1.17; P < .00001) and significantly higher with 10 mg vs 5 mg tofacitinib (P = .03).
Study details: The data come from a systematic review and meta-analysis of 17 phase 2/3 randomized controlled trials including 6802 patients with PsA or moderate-to-severe plaque psoriasis who received ≥1 JAKi.
Disclosures: This study was supported by the National Basic Research Program of China. The authors declared no conflicts of interest.
Source: Yang F et al. Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: A systematic review and meta‑analysis. Clin Rheumatol. 2023 (Feb 10). Doi: 10.1007/s10067-023-06529-4
Key clinical point: All Janus kinase inhibitors (JAKi) were more effective than placebo in patients with psoriatic arthritis (PsA), but led to a higher overall incidence of adverse events, particularly at higher doses.
Major finding: JAKi vs placebo were associated with a significantly higher American College of Rheumatology 20 response rate (relative risk [RR] 2.09; P < .00001), with the response being the highest for filgotinib (RR 2.40; P < .00001), followed by upadacitinib, tofacitinib, and deucravacitinib. However, the overall incidence of adverse events was higher with JAKi vs placebo (RR 1.17; P < .00001) and significantly higher with 10 mg vs 5 mg tofacitinib (P = .03).
Study details: The data come from a systematic review and meta-analysis of 17 phase 2/3 randomized controlled trials including 6802 patients with PsA or moderate-to-severe plaque psoriasis who received ≥1 JAKi.
Disclosures: This study was supported by the National Basic Research Program of China. The authors declared no conflicts of interest.
Source: Yang F et al. Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: A systematic review and meta‑analysis. Clin Rheumatol. 2023 (Feb 10). Doi: 10.1007/s10067-023-06529-4
Key clinical point: All Janus kinase inhibitors (JAKi) were more effective than placebo in patients with psoriatic arthritis (PsA), but led to a higher overall incidence of adverse events, particularly at higher doses.
Major finding: JAKi vs placebo were associated with a significantly higher American College of Rheumatology 20 response rate (relative risk [RR] 2.09; P < .00001), with the response being the highest for filgotinib (RR 2.40; P < .00001), followed by upadacitinib, tofacitinib, and deucravacitinib. However, the overall incidence of adverse events was higher with JAKi vs placebo (RR 1.17; P < .00001) and significantly higher with 10 mg vs 5 mg tofacitinib (P = .03).
Study details: The data come from a systematic review and meta-analysis of 17 phase 2/3 randomized controlled trials including 6802 patients with PsA or moderate-to-severe plaque psoriasis who received ≥1 JAKi.
Disclosures: This study was supported by the National Basic Research Program of China. The authors declared no conflicts of interest.
Source: Yang F et al. Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: A systematic review and meta‑analysis. Clin Rheumatol. 2023 (Feb 10). Doi: 10.1007/s10067-023-06529-4
Guselkumab resolves dactylitis and improves clinical outcomes in patients with active PsA
Key clinical point: Guselkumab effectively resolved dactylitis in the majority of patients with psoriatic arthritis (PsA), with improvements sustained through 1 year, which in turn improved other clinical outcomes.
Major finding: At week 24, a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks (Q4W or Q8W) vs placebo (63.5% or 59.4% vs 42.2%, respectively; P < .05) achieved dactylitis resolution; approximately 80% of patients receiving guselkumab achieved ≥70% improvement in dactylitis severity score by week 52. Patients with resolved dactylitis at week 24 were more likely to achieve American College of Rheumatology 50 response and other clinical outcomes (P < .05).
Study details: This pooled analysis included 1120 patients with active PsA from the phase 3 DISCOVER-1 and DISCOVER-2 studies who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W or placebo.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors declared being employees, holding patents, or having other ties with Janssen or other sources.
Source: McGonagle D et al. Guselkumab, a selective Interleukin-23 p19 subunit Inhibitor, resolves dactylitis in patients with active psoriatic arthritis: Pooled results through week 52 from two phase 3 studies. ACR Open Rheumatol. 2023 (Mar 7). Doi: 10.1002/acr2.11537
Key clinical point: Guselkumab effectively resolved dactylitis in the majority of patients with psoriatic arthritis (PsA), with improvements sustained through 1 year, which in turn improved other clinical outcomes.
Major finding: At week 24, a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks (Q4W or Q8W) vs placebo (63.5% or 59.4% vs 42.2%, respectively; P < .05) achieved dactylitis resolution; approximately 80% of patients receiving guselkumab achieved ≥70% improvement in dactylitis severity score by week 52. Patients with resolved dactylitis at week 24 were more likely to achieve American College of Rheumatology 50 response and other clinical outcomes (P < .05).
Study details: This pooled analysis included 1120 patients with active PsA from the phase 3 DISCOVER-1 and DISCOVER-2 studies who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W or placebo.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors declared being employees, holding patents, or having other ties with Janssen or other sources.
Source: McGonagle D et al. Guselkumab, a selective Interleukin-23 p19 subunit Inhibitor, resolves dactylitis in patients with active psoriatic arthritis: Pooled results through week 52 from two phase 3 studies. ACR Open Rheumatol. 2023 (Mar 7). Doi: 10.1002/acr2.11537
Key clinical point: Guselkumab effectively resolved dactylitis in the majority of patients with psoriatic arthritis (PsA), with improvements sustained through 1 year, which in turn improved other clinical outcomes.
Major finding: At week 24, a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks (Q4W or Q8W) vs placebo (63.5% or 59.4% vs 42.2%, respectively; P < .05) achieved dactylitis resolution; approximately 80% of patients receiving guselkumab achieved ≥70% improvement in dactylitis severity score by week 52. Patients with resolved dactylitis at week 24 were more likely to achieve American College of Rheumatology 50 response and other clinical outcomes (P < .05).
Study details: This pooled analysis included 1120 patients with active PsA from the phase 3 DISCOVER-1 and DISCOVER-2 studies who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W or placebo.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors declared being employees, holding patents, or having other ties with Janssen or other sources.
Source: McGonagle D et al. Guselkumab, a selective Interleukin-23 p19 subunit Inhibitor, resolves dactylitis in patients with active psoriatic arthritis: Pooled results through week 52 from two phase 3 studies. ACR Open Rheumatol. 2023 (Mar 7). Doi: 10.1002/acr2.11537
Active disease in third trimester increases risk for emergency caesarean section in PsA
Key clinical point: Women with psoriatic arthritis (PsA) were at an increased risk for emergency caesarean section, with active disease in the third trimester further amplifying the risk, highlighting the importance of pregestational counseling and disease control along with systematic monitoring during pregnancy.
Major finding: Compared with control individuals, women with PsA had a higher risk for caesarean section (risk difference [RD] 15.0%; P < .001) and for emergency caesarean section (RD 10.6%; P < .001), with active disease in the third trimester further amplifying both risks (caesarean section: RD 17.7%; P = .028; emergency caesarean section: RD 15.9%; P = .015).
Study details: The data come from a population-based cohort study that included women with PsA (n = 121), women with axial spondyloarthritis (n = 312), and control individuals (n = 575,798) with singleton births.
Disclosures: This study was funded by The Norwegian Women’s Public Health Association. The authors did not declare any conflicts of interest.
Source: Skorpen CG et al. Caesarean section in women with axial spondyloarthritis and psoriatic arthritis: A population-based study. RMD Open. 2023;9(1):e002760 (Mar 2). Doi: 10.1136/rmdopen-2022-002760
Key clinical point: Women with psoriatic arthritis (PsA) were at an increased risk for emergency caesarean section, with active disease in the third trimester further amplifying the risk, highlighting the importance of pregestational counseling and disease control along with systematic monitoring during pregnancy.
Major finding: Compared with control individuals, women with PsA had a higher risk for caesarean section (risk difference [RD] 15.0%; P < .001) and for emergency caesarean section (RD 10.6%; P < .001), with active disease in the third trimester further amplifying both risks (caesarean section: RD 17.7%; P = .028; emergency caesarean section: RD 15.9%; P = .015).
Study details: The data come from a population-based cohort study that included women with PsA (n = 121), women with axial spondyloarthritis (n = 312), and control individuals (n = 575,798) with singleton births.
Disclosures: This study was funded by The Norwegian Women’s Public Health Association. The authors did not declare any conflicts of interest.
Source: Skorpen CG et al. Caesarean section in women with axial spondyloarthritis and psoriatic arthritis: A population-based study. RMD Open. 2023;9(1):e002760 (Mar 2). Doi: 10.1136/rmdopen-2022-002760
Key clinical point: Women with psoriatic arthritis (PsA) were at an increased risk for emergency caesarean section, with active disease in the third trimester further amplifying the risk, highlighting the importance of pregestational counseling and disease control along with systematic monitoring during pregnancy.
Major finding: Compared with control individuals, women with PsA had a higher risk for caesarean section (risk difference [RD] 15.0%; P < .001) and for emergency caesarean section (RD 10.6%; P < .001), with active disease in the third trimester further amplifying both risks (caesarean section: RD 17.7%; P = .028; emergency caesarean section: RD 15.9%; P = .015).
Study details: The data come from a population-based cohort study that included women with PsA (n = 121), women with axial spondyloarthritis (n = 312), and control individuals (n = 575,798) with singleton births.
Disclosures: This study was funded by The Norwegian Women’s Public Health Association. The authors did not declare any conflicts of interest.
Source: Skorpen CG et al. Caesarean section in women with axial spondyloarthritis and psoriatic arthritis: A population-based study. RMD Open. 2023;9(1):e002760 (Mar 2). Doi: 10.1136/rmdopen-2022-002760