Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00498-x
Post hoc analysis from the FINCH 1 study highlights filgotinib as a potential beneficial treatment option for patients with RA who have had inadequate response to MTX and have high risk of disease progression and poor prognosis.
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-week Results from the Keepsake 2 Study
Rheumatology (Oxford). 2022 doi: 10.1093/rheumatology/keac605
This study reported the long-term efficacy, safety, and tolerability of RZB through 52 weeks of treatment in KEEPsAKE 2. In doing so it demonstrated long-term, durable efficacy of risankizumab in improving symptom control, physical function and quality of life in patients with active PsA who were csDMARD-IR or Bio-IR.
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.
Efficacy and Safety of Selective TYK2 Inhibitor, Deucravacitinib, in a Phase II Trial in Psoriatic Arthritis
Ann Rheum Dis. 2022 doi: 10.1136/annrheumdis-2021-221664
In this study Mease, et al. aimed to evaluate the efficacy and safety of deucravacitinib in patients with active PsA. Treatment with the selective TYK2i deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20 as well as Multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients.
Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study
RMD Open. 2022;8(1):e002110 doi: 10.1136/rmdopen-2021-002110Vaccine sub-study of the BALANCE-EXTEND upadacitinib trial finds that approximately two-thirds of patients receiving upadacitinib 15 mg once-daily achieve a satisfactory humoral response to pneumococcal 13-valent conjugate (PCV-13) vaccine, despite receiving concomitant methotrexate (MTX).It is well known that a weakened immune response, comorbidities and immunosuppressant drug therapy all contribute to an increased susceptibility to infections in patients with RA. Likewise, the morbidity and mo...
Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years
Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221051Integrated analysis evaluates the safety of filgotinib among patients with RA treated for a median of 1.6 years.Winthrop, et al. analysed data from seven trials, including long-term extension studies, and found that rates of TEAEs, grade ≥3 TEAEs, serious TEAEs and TEAEs leading to study drug discontinuation were comparable for filgotinib and placebo. In addition, analysis of AEs of special interest showed a generally similar incidence for filgotinib 200 mg and 100 mg....
Filgotinib Versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: A Phase III Randomised Clinical Trial
Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...
Safety and Efficacy of Tofacitinib in Patients with Active Psoriatic Arthritis: Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study
Rheumatol Ther 2020 doi.org/10.1007/s40744-020-00209-4This 3-year, open-label, LTE study follows PsA patients previously treated in pivotal studies OPAL Broaden and OPAL Beyond. It demonstrates maintained safety and efficacy of tofacitinib up to 36 and 30 months, respectively. No new safety concerns are highlighted. Previous P3 studies, OPAL Broaden and OPAL Beyond, demonstrated safety and efficacy of 5mg and 10mg tofacitinib BID in PsA. These patients rolled over to OPAL Balance for a period of 36 months. 686 participants were used in this interim...
A Pooled analysis of the Safety of Tofacitinib as Monotherapy or in Combination with Background Conventional Synthetic Disease-Modifying Antirheumatic Drugs in a Phase 3 Rheumatoid Arthritis Population
Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006.In this pooled analysis of Phase 3 Tofacitinib (TOF) trials, safety profiles were generally similar between patients receiving monotherapy and combination therapy. Although selected adverse events of interest showed lower incidence rates (IRs) for TOF monotherapy patients.TOF has been studied as monotherapy and in combination with csDMARDs. In this post-hoc analysis, data were pooled from six Phase 3 TOF studies in RA patients to further examine the safety profile when used as monotherapy or in ...
Please click the links below to go to the CSF review of each paper2018 brought a wealth of new data in cytokine signalling and IL-6 that helps inform current clinical practice and brings the promise of new options in the future. There was good data on the use of sub cutaneous tocilizumab as well as strategies in early RA and for methotrexate tapering. For the currently marketed JAK inhibitors, tofacitinib and baricitinib, continuous long-term efficacy and safety data further support its current use and applications. On the development side, the outcomes of the...