February 2023

The Effect of Guselkumab on Inhibiting Radiographic Progression in Patients with Active Psoriatic Arthritis: Study Protocol for APEX, a Phase 3b, Multicenter, Randomized, Double‑blind, Placebo‑controlled Trial

Trials. 2023 doi: 10.1186/s13063-022-06945-y

Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.

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Herpes zoster in Patients with Inflammatory Arthritides or Ulcerative Colitis Treated with Tofacitinib, Baricitinib or Upadacitinib: A Systematic Review of Clinical Trials and Real-world Studies

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

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Selective Inhibition of the MK2 Pathway: Data From a Phase IIa Randomized Clinical Trial in Rheumatoid Arthritis

ACR Open Rheumatol. 2023;5(2):63–70 doi: 10.1002/acr2.11517

Data show that the first-in-class MK2 pathway inhibitor ATI-450 was well tolerated and induced sustained anti-inflammatory efficacy over 12 weeks in patients with moderate-to-severe RA.

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Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023;82(4):575–577 doi: 10.1136/ard-2022-223406

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

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January 2023

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022;74:1943–58

In this open-label extension study of BE AGILE, the safety profile of bimekizumab was found to be consistent with previously demonstrated findings, and no new safety signals were identified. The objective was to assess the long-term safety, tolerability, and efficacy of bimekizumab in patients with active AS.

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Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022 doi: 10.1002/art.42280

This study highlighted that the safety of bimekizumab in patients with PsA over 3 years of treatment was consistent with the previous 48-week results, as well as other recently published studies of IL-17 inhibitors in PsA patients.

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Bimekizumab In Patients with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumour Necrosis Factor-Α Inhibitors: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial

Lancet. 2023 doi: 10.1016/S0140-6736(22)02303-0

This study showed rapid and clinically meaningful improvements with bimekizumab treatment in patients experiencing active PsA and showing an inadequate response or intolerance to TNFα inhibitors. Its chief aim was to evaluate the efficacy and safety of bimekizumab in patients with an inadequate response or intolerance to TNFα inhibitors.

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Bimekizumab in Patients with Psoriatic Arthritis, Naive To Biologic Treatment: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial (BE OPTIMAL)

Lancet. 2023 doi: 10.1016/S0140-6736(22)02302-9

This study showed that bimekizumab treatment resulted in clinically meaningful and consistent improvements across multiple measures in bDMARD-naïve patients with active PsA. It aimed to assess the efficacy and safety of bimekizumab in patients with active PsA who were naive to bDMARDs.

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Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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