Upadacitinib as monotherapy or in combination with background MTX was effective in inhibiting the progression of structural joint damage through Week 48 in MTX-naïve and MTX‐inadequate responder patients with RA.Recently approved in many countries for the treatment of RA, upadacitinib has been shown to significantly reduce the progression of structural joint damage in two Phase 3 studies (SELECT-EARLY and SELECT-COMPARE). In this analysis, Peterfy, et al. evaluated the progression of structural ...
January 2022
Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients
J Clin Rheumatol. 2021;27(8):e482–e490
This post hoc analysis of pooled data from 21 clinical trials in the tofacitinib clinical trial programme highlights the importance of identifying known risk factors of RA-interstitial lung disease (ILD) in clinical practice.Citera, et al. investigated incidence rates of ILD – an extra-articular manifestation of RA – in patients with RA, receiving tofacitinib 5 or 10 mg BID and sort to identify potential risk factors for ILD in these patients....
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December 2021
Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study
Ann Rheum Dis. 2021 Apr 27;80(8):1004–13.
A Phase 3 study assesses the efficacy and safety of tofacitinib in adults with active AS.Deodhar, et al. found that ASAS20 and ASAS40 response rate significantly increased with tofacitinib 5 mg BID versus placebo at Week 16, with improvements maintained to Week 48.There were no new safety signals detected over the course of the study....
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Highlights of 2021
Please click the links below to go to the CSF review of each paper
I’m sure we’d all hoped that this year would be a return to normal but, in the midst of the challenges we’ve faced with COVID-19, the rheumatology community has continued to deliver excellent publications, and we’ve covered many of these on the CSF. Here are my highlights from 2021's publications: Points to Consider for the Treatment of Immune-Mediated Inflammatory Diseases With Janus Kinase Inhibitors: A Co...
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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-2021-221051
Integrated 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....
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Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial
Lancet. 2021;398(10315):1984–96
Pivotal trial data show that tofacitinib is an effective treatment in patients with polyarticular course juvenile idiopathic arthritis (pJIA).New oral therapies are particularly relevant for children and adolescents, who might prefer to avoid injections. To this end, Ruperto, et al. assessed the efficacy and safety of tofacitinib versus placebo in patients with pJIA (N=225). They observed a JIA flare rate at Week 44 of 29% and 53% for tofacitinib and placebo, respectively. Safety results were si...
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November 2021
Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials
Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-220822.
JAKinibs have been linked with an increased risk of HZ in patients with RA. To this end, Winthrop, et al. evaluated data from six Phase III clinical trials to determine the incidence of HZ in the upadacitinib (UPA)-treated patients with RA and identify potential risk factors for the development of HZ in these patients.Analysis of data provides further support for the need for continued vigilance and monitoring for signs of herpes zoster (HZ) in patients receiving UPA, particularly in Asian popul...
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Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database
Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.
Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...
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A review of JAK-STAT signalling in the pathogenesis of spondyloarthritis and the role of JAK inhibition
Rheumatology (Oxford). 2021. Epub ahead of print. doi: 10.1093/rheumatology/keab740.
JAK inhibitors are likely to become an important part of the overall treatment paradigm for spondyloarthritis (SpA).Although not fully understood, the pathogenesis of SpA is complex and thought to involve both environmental and genetic factors that together elicit a chronic inflammatory response involving the innate and adaptive immune systems. Several different cytokines, TNF, IL-17A, IL-12/23 and IL-23, which are directly/indirectly affected by JAK molecules, are involved in the pathogenesis o...
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Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study
RMD Open. 2021;7(3):e001838
Analysis of data over 56 weeks shows that efficacy responses are maintained with upadacitinib 15 mg and 30 mg.Following the publication of 12-week data from the Phase III, randomised double-blind, SELECT-PsA 1 study, earlier this year, McInnes, et al. now report the 56-week efficacy and safety data of upadacitinib 15 mg and 30 mg in patients with PsA and an inadequate response to non-biological therapyEfficacy responses and inhibition of radiographic progression were maintained with upadacitinib...