May 2024

Ozanimod as induction therapy and maintenance therapy for ulcerative colitis

N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617

Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.

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April 2024

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

https://pubmed.ncbi.nlm.nih.gov/33549192/

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

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Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): Efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled Phase 3 trial

Lancet 2021;397:487–98. doi: 10.1016/S0140-6736(21)00125-2

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

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Bimekizumab versus adalimumab in plaque psoriasis

N Engl J Med 2021; 385:130–41. doi: 10.1056/NEJMoa2102388

Bimekizumab was noninferior and superior to adalimumab with respect to PASI 90 response and IGA score at Week 16. Bimekizumab is a promising IL-17A/F inhibitor that has shown clinical improvement in PsO patients compared to placebo and other IL inhibitors. Warren et al. compared the safety and efficacy of bimekizumab with adalimumab in a 56-week double-blind trial.

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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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