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.
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.
Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 3-Year Results from a Phase 2b Randomized Controlled Trial and its Open-Label Extension Study
Arthritis Rheumatol 2022 doi: 10.1002/art.42282
Bimekizumab is associated with sustained, long-term efficacy in r-axSpA patinets across three years of treatment. In coming to this conclusion, investigators sought to assess the long-term safety, tolerability, and efficacy of bimekizumab in active r-axSpA.
Safety and Efficacy of Bimekizumab in Patients with Active Psoriatic Arthritis: 3-Year Results from a Phase 2b Randomized Controlled Trial and its Open-Label Extension Study
Arthritis Rheumatol 2022 doi: 10.1002/art.42280
In this investigation bimekizumab was associated with a sustained ACR50 improvement. This was highlighted following the attempt to describe the long-term safety, tolerability, and efficacy of up to three years of bimekizumab treatment in PsA patients
Filgotinib, a Novel JAK1-Preferential Inhibitor for the Treatment of Rheumatoid Arthritis: An Overview from Clinical Trials
Mod Rheumatol. 2021 Mar 19:1-26. Epub ahead of print. DOI 10.1080/14397595.2021.1902617Filgotinib is the latest JAKinib to enter the international market for the treatment of RA, receiving regulatory approval in Japan and Europe late last year. In this review paper, Tanaka Y et al. examine the clinical evidence supporting its use as a later-line treatment, in accordance with international RA management guidelines, and provide their expert opinions on JAKinibs from a clinical perspective.The core clinical programme evaluating filgotinib in patients with moderately-to-severely activ...
Safety and Efficacy of Filgotinib: Up to 4-Year Results From an Open-Label Extension Study of Phase 2 Rheumatoid Arthritis Programs
J Rheumatol. 2021 Feb 1:jrheum.201183. DOI: 10.3899/jrheum.201183.A long-term extension study of filgotinib showed consistent safety profile and sustained efficacy with the drug for up to four years. The DARWIN 3 study, for patients who previously completed either the 24-week DARWIN 1 study (filgotinib + MTX) or the DARWIN 2 study (filgotinib monotherapy), enrolled 739 patients with RA. At the time of analysis, 440 patients had received four years or more of filgotinib. Exposure-adjusted incidence rate per 100 patient-years-of-exposure for TEAEs was 24.6 in th...
Please click the links below to go to the CSF review of each paper2020 unfolded apace, dominated by COVID-19 - we have all had to adapt in our practice and in our knowledge base. Amid this there have continued to be a constant flow of publications and science in cytokine signaling, and as in previous years as we come the end of 2020, I will highlight some of the notable papers of the year. You can find the most notable papers, as selected by CSF Steering Committee Chair Professor Iain McInnes, with links to their respective detailed summaries below:
Filgotinib, a JAK1 Inhibitor, Modulates Disease Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials
Rheumatol Ther. 2020 DOI: 10.1007/s40744-019-00192-5In this study examining the effect of FIL on a panel of biomarkers, FIL down-modulated several key inflammatory mediators of signalling pathways in RA - independent of MTX background therapy. This confirmed the strong network effects of the JAK1 node in autoimmunity, matrix and cartilage degradation, angiogenesis, and leukocyte adhesion and recruitment. Biomarkers key to RA pathophysiology were measured at baseline, Wk4 and Wk12 in FIL 100 mg, FIL 200 mg or PBO treatment groups from two phase 2b...
Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase 2 and 3 Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis
Clin Pharmacol Ther . 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671.UPA 15 mg provided the optimal benefit-risk in RA through maximizing efficacy with only small incremental benefit with 30 mg, and with consistency across RA subpopulations and with UPA monotherapy or combination with csDMARDs. Exposure-response analyses were conducted using combined data from two Phase 2b and five Phase 3 studies in order to characterise the relationship between plasma exposure and efficacy, as well as to select safety parameters using the totality of the data in subjects with R...
Effect of Filgotinib, a Selective JAK1 Inhibitor, with or without Methotrexate in Patients with Rheumatoid Arthritis: Patient-Reported Outcomes
Arthritis Res Ther 2018; 20(1):57 doi: 10.1186/s13075-018-1541-zPatient-reported outcomes (PROs) from two, Phase 2b, filgotinib (FIL) studies, DARWIN 1 and 2, revealed that patients receiving FIL had improved and sustained PRO responses compared with placebo. With suboptimal RA treatment, patients lose joint functional ability, which heavily influences patient quality of life. The previously reported data from the DARWIN studies, concluded that patients given FIL achieved clinically relevant dose-dependent improvements compared with patients given placebo¹,²...