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Showing 35 results for “Phase 3 trial”.

November 2023

Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic Disease-Modifying Antirheumatic Drug Use: A Post Hoc Analysis

ACR Open Rheumatol. 2023 Sep 29 doi 10.1002/acr2.11601 Epub ahead of print

In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.

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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 doi:10.1007/s40264-023-01361-w. Epub ahead of print

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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July 2023

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

Lancet. 2023 S0140-6736(23)00921-2 doi 10.1016/S0140-6736(23)00921-2 Epub ahead of print

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 doi: 10.1093/mr/road059 Epub ahead of print

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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April 2023

Sex Differences in the Efficacy, Safety and Persistence of Patients with Psoriatic Arthritis Treated with Tofacitinib: A Post Hoc Analysis of Phase 3 Trials and Long-Term Extension

RMD Open 2023;9:e002718 doi 10.1136/rmdopen-2022-002718

Evidence from two phase 3 RCTs and one LTE shows that while tofacitinib efficacy exceeds placebo in both sexes and is comparable between sexes, males are more likely to achieve minimal disease activity than females.

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January 2023

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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September 2022

Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis

N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302

Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.

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August 2022

Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

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