December 2023

MACE and VTE across Upadacitinib Clinical Trial Programmes in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

RMD Open 2023; 9(4):e003392 doi 10.1136/rmdopen-2023-003392

Rates of MACE and VTE events in patients with RA or PsA treated are consistent across 15 mg and 30 mg doses of upadacitinib, and comparable with active comparators adalimumab and MTX. Several risk factors were also identified for MACE and VTE events in patients with RA.

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Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis

Rheumatol Ther 2023;11(1):97–112 doi 10.1007/s40744-023-00621-6

Rates of malignancy were similar between upadacitinib, adalimumab, and MTX. They were also consistent across RA, PsA, AS and nr-axSpA. A dose-dependent increased rate of NMSC was observed with upadacitinib in RA. For RA and PsA, being older (≥65 years) and male was associated with
an increased risk of malignancy excluding NMSC.

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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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Anti-GM-CSF Otilimab Versus Tofacitinib or Placebo in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Conventional or Biologic DMARDs: Two Phase 3 Randomised Trials (contRAst 1 and contRAst 2)

Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482

Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.

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July 2023

Baricitinib in Juvenile Idiopathic Arthritis: An International, Phase 3, Randomised, Double-blind, Placebo-controlled, Withdrawal, Efficacy, and Safety Trial

Lancet. 2023;402(10401):555–570 doi 10.1016/S0140-6736(23)00921-2

Phase 3 trial of baricitinib demonstrates efficacy with acceptable safety profile in polyarticular and extended oligoarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis and enthesitis-related arthritis.

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Post Hoc Analysis of Patients with Rheumatoid Arthritis Under Clinical Remission in Two Japanese Phase 3 Trials of Peficitinib Treatment (RAJ3 and RAJ4)

Mod Rheumatol 2023;34(3):453–65 doi: 10.1093/mr/road059

Pots hoc analysis of peficitinib Phase 3 trials shows that continued treatment with peficitinib up to Week 52 is linked to improved remission rates in Asian patients with RA.

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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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