Psoriatic Arthritis

The U.S. Food and Drug Administration approved a 15-mg extended release tablet of upadacitinib (Rinvoq) for adults with psoriatic arthritis who had an inadequate response or intolerance to one or more anti-tumor necrosis factor drugs, manufacturer AbbVie announced December 14.
 

The approval is the second indication given by the agency for the selective Janus kinase (JAK) inhibitor upadacitinib, which was previously approved for rheumatoid arthritis (RA) in 2019.

Upadacitinib 15 mg is also approved by the European Commission for adults with RA, psoriatic arthritis, and ankylosing spondylitis. The European Commission also approved the drug for moderate to severe atopic dermatitis at both 15- and 30-mg doses for adults and at 15 mg for adolescents.

The approval is based on two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which together randomized more than 2,300 patients with psoriatic arthritis. In the trials, significantly more patients who took upadacitinib 15 mg met their primary endpoint of 20% improvement in American College of Rheumatology response criteria (ACR20) at week 12 (71% in SELECT-PsA 1 and 57% in SELECT-PsA 2) vs placebo (36% and 24%, respectively). Both trials also included treatment arms for upadacitinib at 30 mg, but the FDA approved only the 15-mg dose.

In the announcement, AbbVie noted that significantly higher percentages of patients treated with upadacitinib 15 mg in the SELECT-PSA 1 and 2 trials, respectively, met ACR50 (38% and 32%) and ACR70 (16% and 9%) criteria than did patients on placebo (13% and 5% for ACR50 and 2% and 1% for ACR70). Symptoms of dactylitis and enthesitis improved with upadacitinib for patients who had them at baseline.

The trials’ 12-week results also indicated that upadacitinib significantly improved physical function relative to placebo at baseline, based on the Health Assessment Questionnaire-Disability Index, as well as fatigue, according to Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scores. Skin manifestations also improved during the trial, but upadacitinib has not been studied for treating plaque psoriasis.

AbbVie reported that the safety results of upadacitinib in the trials were consistent with the results seen in patients with rheumatoid arthritis, and during the trials’ 24-week placebo-controlled period, the most common adverse events reported with upadacitinib were upper respiratory tract infection and blood creatine phosphokinase elevations.

Upadacitinib comes with a boxed warning that was formally placed on the drug’s label this month after data from a postmarketing trial of the JAK inhibitor tofacitinib (Xeljanz and Xeljanz XR) in patients with RA aged 50 years and older with at least one cardiovascular risk factor showed numerically higher risks for all-cause mortality; lymphoma and other malignancies; major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke); and thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis.

Upadacitinib also carries a boxed warning for an elevated risk of serious infection leading to hospitalization or death. In the SELECT-PsA 1 and 2 trials overall, rates of herpes zoster and herpes simplex were 1.1% and 1.4% with upadacitinib, compared with 0.8% and 1.3% with placebo.

Phase 3 trials of upadacitinib in RA, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis are ongoing, according to AbbVie.

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

The U.S. Food and Drug Administration approved a 15-mg extended release tablet of upadacitinib (Rinvoq) for adults with psoriatic arthritis who had an inadequate response or intolerance to one or more anti-tumor necrosis factor drugs, manufacturer AbbVie announced December 14.
 

The approval is the second indication given by the agency for the selective Janus kinase (JAK) inhibitor upadacitinib, which was previously approved for rheumatoid arthritis (RA) in 2019.

Upadacitinib 15 mg is also approved by the European Commission for adults with RA, psoriatic arthritis, and ankylosing spondylitis. The European Commission also approved the drug for moderate to severe atopic dermatitis at both 15- and 30-mg doses for adults and at 15 mg for adolescents.

The approval is based on two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which together randomized more than 2,300 patients with psoriatic arthritis. In the trials, significantly more patients who took upadacitinib 15 mg met their primary endpoint of 20% improvement in American College of Rheumatology response criteria (ACR20) at week 12 (71% in SELECT-PsA 1 and 57% in SELECT-PsA 2) vs placebo (36% and 24%, respectively). Both trials also included treatment arms for upadacitinib at 30 mg, but the FDA approved only the 15-mg dose.

In the announcement, AbbVie noted that significantly higher percentages of patients treated with upadacitinib 15 mg in the SELECT-PSA 1 and 2 trials, respectively, met ACR50 (38% and 32%) and ACR70 (16% and 9%) criteria than did patients on placebo (13% and 5% for ACR50 and 2% and 1% for ACR70). Symptoms of dactylitis and enthesitis improved with upadacitinib for patients who had them at baseline.

The trials’ 12-week results also indicated that upadacitinib significantly improved physical function relative to placebo at baseline, based on the Health Assessment Questionnaire-Disability Index, as well as fatigue, according to Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scores. Skin manifestations also improved during the trial, but upadacitinib has not been studied for treating plaque psoriasis.

AbbVie reported that the safety results of upadacitinib in the trials were consistent with the results seen in patients with rheumatoid arthritis, and during the trials’ 24-week placebo-controlled period, the most common adverse events reported with upadacitinib were upper respiratory tract infection and blood creatine phosphokinase elevations.

Upadacitinib comes with a boxed warning that was formally placed on the drug’s label this month after data from a postmarketing trial of the JAK inhibitor tofacitinib (Xeljanz and Xeljanz XR) in patients with RA aged 50 years and older with at least one cardiovascular risk factor showed numerically higher risks for all-cause mortality; lymphoma and other malignancies; major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke); and thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis.

Upadacitinib also carries a boxed warning for an elevated risk of serious infection leading to hospitalization or death. In the SELECT-PsA 1 and 2 trials overall, rates of herpes zoster and herpes simplex were 1.1% and 1.4% with upadacitinib, compared with 0.8% and 1.3% with placebo.

Phase 3 trials of upadacitinib in RA, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis are ongoing, according to AbbVie.

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

The U.S. Food and Drug Administration approved a 15-mg extended release tablet of upadacitinib (Rinvoq) for adults with psoriatic arthritis who had an inadequate response or intolerance to one or more anti-tumor necrosis factor drugs, manufacturer AbbVie announced December 14.
 

The approval is the second indication given by the agency for the selective Janus kinase (JAK) inhibitor upadacitinib, which was previously approved for rheumatoid arthritis (RA) in 2019.

Upadacitinib 15 mg is also approved by the European Commission for adults with RA, psoriatic arthritis, and ankylosing spondylitis. The European Commission also approved the drug for moderate to severe atopic dermatitis at both 15- and 30-mg doses for adults and at 15 mg for adolescents.

The approval is based on two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which together randomized more than 2,300 patients with psoriatic arthritis. In the trials, significantly more patients who took upadacitinib 15 mg met their primary endpoint of 20% improvement in American College of Rheumatology response criteria (ACR20) at week 12 (71% in SELECT-PsA 1 and 57% in SELECT-PsA 2) vs placebo (36% and 24%, respectively). Both trials also included treatment arms for upadacitinib at 30 mg, but the FDA approved only the 15-mg dose.

In the announcement, AbbVie noted that significantly higher percentages of patients treated with upadacitinib 15 mg in the SELECT-PSA 1 and 2 trials, respectively, met ACR50 (38% and 32%) and ACR70 (16% and 9%) criteria than did patients on placebo (13% and 5% for ACR50 and 2% and 1% for ACR70). Symptoms of dactylitis and enthesitis improved with upadacitinib for patients who had them at baseline.

The trials’ 12-week results also indicated that upadacitinib significantly improved physical function relative to placebo at baseline, based on the Health Assessment Questionnaire-Disability Index, as well as fatigue, according to Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scores. Skin manifestations also improved during the trial, but upadacitinib has not been studied for treating plaque psoriasis.

AbbVie reported that the safety results of upadacitinib in the trials were consistent with the results seen in patients with rheumatoid arthritis, and during the trials’ 24-week placebo-controlled period, the most common adverse events reported with upadacitinib were upper respiratory tract infection and blood creatine phosphokinase elevations.

Upadacitinib comes with a boxed warning that was formally placed on the drug’s label this month after data from a postmarketing trial of the JAK inhibitor tofacitinib (Xeljanz and Xeljanz XR) in patients with RA aged 50 years and older with at least one cardiovascular risk factor showed numerically higher risks for all-cause mortality; lymphoma and other malignancies; major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke); and thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis.

Upadacitinib also carries a boxed warning for an elevated risk of serious infection leading to hospitalization or death. In the SELECT-PsA 1 and 2 trials overall, rates of herpes zoster and herpes simplex were 1.1% and 1.4% with upadacitinib, compared with 0.8% and 1.3% with placebo.

Phase 3 trials of upadacitinib in RA, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis are ongoing, according to AbbVie.

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

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

Key clinical point: Tumor necrosis factor (TNF)-α inhibitors effectively improved skin, nail, and joint symptoms and quality of life (QoL) in patients with nail psoriasis and concomitant psoriatic arthritis (PsA).

Major finding: During the first 3 months, nail psoriasis improved significantly along with improvements in the mean number of swollen joints (SJ), which reduced from 6.4 to 3.1, and the mean number of tender joints, which reduced from 10.8 to 6.4 (both P < .001). Low disease activity according to SJ status was achieved at month 24. QoL improved by 50% (P < .001) after 3 months with further improvements up to month 24.

Study details: Findings are from a noninterventional, prospective cohort study that evaluated effectiveness of 24 months of continuous therapy with adalimumab, etanercept, or infliximab in 100 adult patients with concomitant psoriasis, nail psoriasis, and PsA.

Disclosures: This study was sponsored by AbbVie Deutschland GmbH & Co. Two authors declared being employees and shareholders of AbbVie, and the other authors reported ties with several sources, including AbbVie Deutschland GmbH & Co.

Source: Kokolakis G et al. J Pers Med. 2021;11(11):1083 (Oct 25). Doi: 10.3390/jpm11111083.

Key clinical point: Tumor necrosis factor (TNF)-α inhibitors effectively improved skin, nail, and joint symptoms and quality of life (QoL) in patients with nail psoriasis and concomitant psoriatic arthritis (PsA).

Major finding: During the first 3 months, nail psoriasis improved significantly along with improvements in the mean number of swollen joints (SJ), which reduced from 6.4 to 3.1, and the mean number of tender joints, which reduced from 10.8 to 6.4 (both P < .001). Low disease activity according to SJ status was achieved at month 24. QoL improved by 50% (P < .001) after 3 months with further improvements up to month 24.

Study details: Findings are from a noninterventional, prospective cohort study that evaluated effectiveness of 24 months of continuous therapy with adalimumab, etanercept, or infliximab in 100 adult patients with concomitant psoriasis, nail psoriasis, and PsA.

Disclosures: This study was sponsored by AbbVie Deutschland GmbH & Co. Two authors declared being employees and shareholders of AbbVie, and the other authors reported ties with several sources, including AbbVie Deutschland GmbH & Co.

Source: Kokolakis G et al. J Pers Med. 2021;11(11):1083 (Oct 25). Doi: 10.3390/jpm11111083.

Key clinical point: Tumor necrosis factor (TNF)-α inhibitors effectively improved skin, nail, and joint symptoms and quality of life (QoL) in patients with nail psoriasis and concomitant psoriatic arthritis (PsA).

Major finding: During the first 3 months, nail psoriasis improved significantly along with improvements in the mean number of swollen joints (SJ), which reduced from 6.4 to 3.1, and the mean number of tender joints, which reduced from 10.8 to 6.4 (both P < .001). Low disease activity according to SJ status was achieved at month 24. QoL improved by 50% (P < .001) after 3 months with further improvements up to month 24.

Study details: Findings are from a noninterventional, prospective cohort study that evaluated effectiveness of 24 months of continuous therapy with adalimumab, etanercept, or infliximab in 100 adult patients with concomitant psoriasis, nail psoriasis, and PsA.

Disclosures: This study was sponsored by AbbVie Deutschland GmbH & Co. Two authors declared being employees and shareholders of AbbVie, and the other authors reported ties with several sources, including AbbVie Deutschland GmbH & Co.

Source: Kokolakis G et al. J Pers Med. 2021;11(11):1083 (Oct 25). Doi: 10.3390/jpm11111083.

Key clinical point: Upadacitinib led to early and sustained clinically meaningful improvements in patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA) having an inadequate response to nonbiologic disease-modifying antirheumatic drugs (non-bDMARD).

Major finding: A greater proportion of patients treated with 15 and 30 mg upadacitinib vs. placebo showed clinically meaningful improvement in the patient global assessment of disease activity, pain, and health assessment questionnaire disability index as early as week 2 (P < .01) which was maintained or further improved at weeks 12 and 24 (P < .01).

Study details: This was a post hoc analysis of the phase 3 SELECT-PsA 1 trial, including 1,704 patients with PsA who had an inadequate response to at least 1 non-bDMARD and who were randomly assigned to upadacitinib, adalimumab, or placebo.

Disclosures: This work was funded by AbbVie. K Kato, E McDearmon-Blondell, P Zueger, and CD Saffore reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.

Source: Strand V et al. Rheumatol Ther. 2021;8:1789-1808 (Oct 12). Doi: 10.1007/s40744-021-00379-9.

Key clinical point: Upadacitinib led to early and sustained clinically meaningful improvements in patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA) having an inadequate response to nonbiologic disease-modifying antirheumatic drugs (non-bDMARD).

Major finding: A greater proportion of patients treated with 15 and 30 mg upadacitinib vs. placebo showed clinically meaningful improvement in the patient global assessment of disease activity, pain, and health assessment questionnaire disability index as early as week 2 (P < .01) which was maintained or further improved at weeks 12 and 24 (P < .01).

Study details: This was a post hoc analysis of the phase 3 SELECT-PsA 1 trial, including 1,704 patients with PsA who had an inadequate response to at least 1 non-bDMARD and who were randomly assigned to upadacitinib, adalimumab, or placebo.

Disclosures: This work was funded by AbbVie. K Kato, E McDearmon-Blondell, P Zueger, and CD Saffore reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.

Source: Strand V et al. Rheumatol Ther. 2021;8:1789-1808 (Oct 12). Doi: 10.1007/s40744-021-00379-9.

Key clinical point: Upadacitinib led to early and sustained clinically meaningful improvements in patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA) having an inadequate response to nonbiologic disease-modifying antirheumatic drugs (non-bDMARD).

Major finding: A greater proportion of patients treated with 15 and 30 mg upadacitinib vs. placebo showed clinically meaningful improvement in the patient global assessment of disease activity, pain, and health assessment questionnaire disability index as early as week 2 (P < .01) which was maintained or further improved at weeks 12 and 24 (P < .01).

Study details: This was a post hoc analysis of the phase 3 SELECT-PsA 1 trial, including 1,704 patients with PsA who had an inadequate response to at least 1 non-bDMARD and who were randomly assigned to upadacitinib, adalimumab, or placebo.

Disclosures: This work was funded by AbbVie. K Kato, E McDearmon-Blondell, P Zueger, and CD Saffore reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.

Source: Strand V et al. Rheumatol Ther. 2021;8:1789-1808 (Oct 12). Doi: 10.1007/s40744-021-00379-9.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.