Safety and Efficacy of Baricitinib in Patients Receiving Conventional Synthetic Disease-Modifying Antirheumatic Drugs or Corticosteroids

Abstract

IntroductionThis study assessed if concomitant use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or corticosteroids altered the response or safety outcomes to baricitinib in rheumatoid arthritis (RA) patients.MethodsPatients with ≥ 6 swollen/tender joints and no prior biologic DMARD were eligible for study inclusion. In RA-BUILD, csDMARD-inadequate responder (IR) patients were randomized to placebo or baricitinib (2 or 4 mg) once daily (QD). In RA-BEAM, methotrexate (MTX)-IR patients were randomized to placebo QD, baricitinib 4-mg QD, or adalimumab 40-mg biweekly. Patients continued background csDMARD (including MTX) therapy. This post hoc analysis of placebo and baricitinib 4-mg patients assessed the number and type of concomitant csDMARDS and concurrent corticosteroid use.ResultsFrom 716 placebo patients, 71, 21, and 6% were taking MTX alone, MTX + ≥ 1 csDMARD, and non-MTX csDMARDs, respectively; from 714 baricitinib patients, the rates were 74, 18, and 6%; 56% of placebo and 55% of baricitinib patients used corticosteroids at baseline (mean dose, 6.0 mg/day for both groups); patients continued use throughout the studies. The odds ratios for achieving American College of Rheumatology response at the 20% improvement level (ACR20) and Clinical Disease Activity Index (CDAI) ≤ 10 at week 12 favored baricitinib for most subgroups; no significant interactions were observed. Rates of adverse events were similar regardless of csDMARD group or corticosteroid use. There were numerically more serious adverse events in placebo patients taking corticosteroids (4.2 vs. 1.6%) and a higher rate of discontinuations in baricitinib patients taking corticosteroids (4.1 vs. 1.2%).ConclusionsBaricitinib was efficacious regardless of concomitant use of csDMARDs or corticosteroids; the incidence of adverse events was similar across all groups of patients.FundingEli Lilly and Company and Incyte Corporation.Electronic supplementary materialThe online version of this article (10.1007/s40744-018-0128-0) contains supplementary material, which is available to authorized users.

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“…As the disease progresses it leads to swelling in joints, deformations and may lead to impairment in functioning [ 70 , 71 ]. It reduces quality of life [ 76 , 77 ]. While there are other anti-rheumatic drugs (DMARDs) available for treatment, patients have not received adequate therapeutic responses to these drugs.…”

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“…В РКИ RA-BUILD вошли пациенты с развернутой стадией РА (длительность заболевания в среднем 8 лет), получавшие без достаточного эффекта как минимум один сБПВП в течение 12 нед (8 нед в стабильной дозе) до рандомизации [25]. Большинство пациентов (49%) получали П р о г р е с с в р е в м а т о л о г и и в X X I в е к е [37]. Особый интерес представляет РКИ RA-BEACON [22], посвященное изучению эффективности БАРИ (2 мг и 4 мг) у пациентов с длительнотекущим (в среднем 14 лет) РА, резистентных к терапии одним или более ГИБП (ингибиторы ФНОα и ГИБП с другим механизмом действия).…”

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“…-In aktuellen Post-hoc-Analysen war Baricitinib sowohl mit als auch ohne Glukokortikoide gleichermaßen wirksam [11]. ▪ Studiendaten belegen Wirksamkeit und Verträglichkeit auch bei älteren Pa tien ten.…”