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
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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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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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...
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September 2021
Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3
RMD Open. 2021;7(2):e001621.
Post hoc analysis of the phase III FINCH study shows that filgotinib may be an alternative treatment option for patients with RA who have poor prognostic factors (PPFs), especially those not responding to standard treatment such as methotrexate (MTX).PPFs are associated with severe disease and risk for disease progression in patients with RA. Consequently, the 2019 EULAR management guidelines for RA recommend early treatment escalation for patients with PPFs who have inadequate response to first...
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August 2021
La monoterapia con upadacitinib migliora i risultati riportati dai pazienti nell'artrite reumatoide: risultati di SELECT-EARLY e SELECT-MONOTHERAPY
Rheumatology (Oxford). 2021;60(7):3209–21
Upadacitinib treatment results in statistically significant and clinically meaningful improvements in health-related quality of life.Strand, et al. evaluated the effect of upadacitinib monotherapy versus methotrexate (MTX) on patient-reported outcomes (PRO) in MTX-naïve and MTX-inadequate responder patients with moderately-to-severely active RA. Their research from the SELECT-EARLY and SELECT-MONOTHERAPY randomised controlled trials found that upadacitinib monotherapy resulted in clinically mean...
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July 2021
Upadacitinib In Pazienti Con Artrite Psoriasica E Risposta Inadeguata Ai Farmaci Biologici: Dati Dallo Studio Randomizzato Controllato Di Fase 3 Select-APS 2 a 56 Settimane
Rheumatol Ther. 2021;8(2):903–919
Fifty-six-week data suggest that upadacitinib could be a favourable long-term treatment option in patients with PsA who are refractory to biologic therapy.As the need for additional therapeutic agents that can effectively control disease activity continues, new data from a 56-week analysis of the oral reversible JAK1 inhibitor, upadacitinib, currently under investigation for the treatment of PsA, shows that efficacy of the drug is maintained over the duration of this study.Mease, et al. explored...
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June 2021
Efficacia Del Trattamento a Lungo Termine con Baricitinib 2 mg die in Pazienti Con Artrite Reumatoide Attiva: Analisi Post Hoc di Due Studi Di Fase III, Randomizzati e Controllati di 24 Settimane e Uno Studio di Estensione a Lungo Termine
Wells AF, et al. Rheumatol Ther. 2021. Epub ahead of print. DOI: 10.1007/s40744-021-00317-9.
Analysis by Wells, et al. demonstrates long-term efficacy and tolerability of baricitinib 2 mg daily for up to 120 weeks in patients with rheumatoid arthritis.Using data from two completed phase III studies, RA-BEAM (csDMARD-IR patients) and RA-BEACON (TNFi-IR patients), and one ongoing long-term extension study (RA-BEYOND), results demonstrated that the long-term maintenance of clinically relevant treatment goals, including LDA, remission and normative physical function, is achievable with bari...