November 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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October 2023

Anti-gm-csf Otilimab versus Sarilumab or Placebo in Patients with Rheumatoid Arthritis and Inadequate Response to Targeted Therapies: A Phase III Randomised Trial (contRAst 3)

Ann Rheum Dis. 2023;82(12):1527–1537 doi 10.1136/ard-2023-224449

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

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Prevention of Radiographic Progression in Higher-Risk Patients with Rheumatoid Arthritis Using Filgotinib in Phase III Studies: Narrative Review of Post Hoc Analyses

Rheumatol Ther. 2023;10(6):1399–1415 doi: 10.1007/s40744-023-00590-w

Findings from post hoc analyses extend the knowledge base for radiographic benefits of filgotinib in patients with RA.

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Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from the Phase III, Randomised, Placebo-Controlled, Active Reference BE OPTIMAL Study

Ann Rheum Dis. 2023;82(11):1404–1414 doi: 10.1136/ard-2023-224431

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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Efficacy and Safety of Upadacitinib in Patients with Ankylosing Spondylitis Refractory to Biologic Therapy: 1-year Results From the Open-label Extension of a Phase III Study

Arthritis Res Ther 2023; 2023;18;25(1):172 doi 10.1186/s13075-023-03128-1

The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.

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September 2023

Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial

Arthritis Rheumatol. 2023;75(8):1370–1380 doi: 10.1002/art.42519

Phase IIb study of brepocitinib in patients with PsA concludes that treatment with brepocitinib 30 mg and 60 mg QD, was superior to placebo at reducing signs and symptoms of PsA and was well-tolerated over 52 weeks.

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The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2

Ther Adv Musculoskelet Dis. 2023;15:1759720X231189005 doi: 10.1177/1759720X231189005

Post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 concludes that ixekizumab (IXE) is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations.

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July 2023

Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

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February 2023

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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January 2023