Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis

Taylor, Peter; Keystone, Edward; Heijde, Desirée van der; Weinblatt, Michael E.; Morales, Liliana; Gonzaga, Jaime Reyes; Yаkushin, S. S.; Ishii, Taeko; Emoto, Kahaku; Beattie, Scott; Arora, Vipin; Gaich, C.; Rooney, Terence; Schlichting, D.; Macias, William L.; Bono, Stephanie de; Tanaka, Yoshiya

doi:10.1056/nejmoa1608345

Cited by 729 publications

(695 citation statements)

References 19 publications

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“…In two global, double-blind phase 3 studies in patients with active RA and either inadequate response (IR) to csDMARDs (RA-BUILD) [8] or IR to methotrexate (RA-BEAM) [9], once daily (QD) baricitinib was associated with clinical improvements through 24 weeks, with an acceptable safety profile. Geographic differences in RA presentation and its management may affect patient outcomes.…”

Section: Introductionmentioning

confidence: 99%

Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis

et al. 2018

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Introduction This article evaluates the efficacy and safety of baricitinib 4 mg versus placebo in United States including Puerto Rico (US) and rest of the world (ROW) subpopulations using data pooled from RA-BEAM and RA-BUILD, which enrolled patients with moderate-to-severe adult-onset rheumatoid arthritis (RA). Methods In RA-BEAM, patients with an inadequate response (IR) to methotrexate, at least one X-ray erosion, and high sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L were randomized to placebo or orally administered baricitinib 4 mg daily or subcutaneously administered adalimumab 40 mg every other week. In RA-BUILD, patients with an IR to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and with hsCRP ≥ 3.6 mg/L were randomized to placebo or baricitinib 2 or 4 mg daily. Patients in both trials were biologic naive. In this post hoc analysis, data from both studies were pooled (714 baricitinib 4 mg-treated, 716 placebo-treated patients). Results Overall, 188 US and 1242 ROW patients were included. Subgroups differed in baseline characteristics including race, weight, age, time since RA diagnosis, current corticosteroid use, and previous csDMARD use. At weeks 12 and 24, baricitinib-treated patients had larger responses compared to placebo-treated patients for multiple efficacy outcomes: American College of Rheumatology 20/50/70 response, low disease activity, remission, Disease Activity Score 28-C-reactive protein, and Health Assessment Questionnaire-Disability Index. Overall, similar efficacy was observed in US and ROW subgroups with no notable safety differences between subgroups at weeks 12 or 24. Conclusion Baricitinib 4 mg was efficacious compared to placebo in US and ROW subpopulations. Safety was similar between subgroups. Funding Eli Lilly & Company and Incyte Corporation. Trial Registration ClinicalTrials.gov identifiers, NCT01721057; NCT01710358.

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Section: Introductionmentioning

confidence: 99%

Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis

et al. 2018

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“…7 The ACR20 response rate at 12 weeks was significantly greater with baricitinib (70%) than adalimumab (61%) (p<0.014) or placebo (40%) (p<0.001). Baricitinib slowed disease progression compared with placebo at 24 weeks, and improved function and reduced disease activity and symptoms at 52 weeks more than adalimumab.…”

Section: Indications and Dosagementioning

confidence: 90%

“…5 RA BUILD 6 and RA BEAM. 7 The primary endpoint was the American College of Rheumatology 20% response (ACR20, a 20% reduction in scores for joints, pain, patient and investigator assessments, and disability). A fourth trial, RA BEGIN, 8 was conducted in patients with little or no prior treatment with DMARDs; they were not selected because a conventional DMARD was unsuitable and therefore they do not fall within the licensed indications.…”

Section: Indications and Dosagementioning

confidence: 99%

Baricitinib: a new oral treatment for rheumatoid arthritis

Chaplin¹

2017

Prescriber

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“…6 After failure of methotrexate therapy (but before treatment with a biological DMARD), tofacitinib and baricitinib have been shown to be non-inferior 7 or superior 8 to the TNF inhibitor adalimumab and to slow disease progression. 8,9 Because long-term safety is currently uncertain, European management guidance recommends that JAK inhibitors should be reserved for use when a biological DMARD proves unsatisfactory. 10 NICE has now appraised both baricitinib and tofacitinib, and recommends them for use only when disease is severe and has responded inadequately to a combination of conventional DMARDs, or if the patient has responded inadequately to or cannot take a biological DMARD.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%