Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study

Abstract

BackgroundTo assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).MethodsIn this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity (PtGA), patient’s assessment of pain and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables.ResultsCompared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p≤0.05).ConclusionsBaricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52).Trial registrationNCT01710358.

Relationship between disease activity and patient-reported outcomes in rheumatoid arthritis: Post hoc analyses of overall and Japanese results from two phase 3 clinical trials

“…RA-BEAM included patients who had a previous inadequate response to MTX, whereas RA-BEGIN included patients who had no or minimal previous DMARD treatment. Details of the individual trials are described in the primary publications [22][23][24][25]. Protocols for both trials were approved by the institutional review boards at all sites and carried out in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice.…”

New insights into IFN-γ in rheumatoid arthritis: role in the era of JAK inhibitors

“…In 2017, the superiority of JAK inhibitor (baricitinib, a JAK1/JAK2 inhibitor) over biologic DMARD (adalimumab, an anti-TNF-a antibody) was for the first time demonstrated in terms of clinical improvements in patients with RA [6]. Interestingly, the improvement of patients reported outcomes, such as pain, fatigue, and quality of life, rather than that of tender or swollen joints assessed by the physician were correlated with the use of baricitinib [6,52]. Based on the findings of some basic studies, the role of IFN-c in pain processing can be speculated.…”

Pharmacoeconomic evaluation of baritinib in the treatment of adult patient with moderate to severe rheumatoid arthritis with intolerance or lack of an adequate response to treatment with one or more basic antirheumatic drugs in the Russian Federation

“…Информационный поиск проводился в базе данных pubmed и Cochrane по ключевым словам «baricitinib» и «rheumatoid arthritis». В результате информационного поиска были обнаружены клинические исследования III фазы, содержащие прямое сравнение барицитиниба и адалимумаба [10,11]. Первая работа, Taylor et al 2017 [10], представляла собой дважды слепое рандомизированное плацебоконтролируемое (а также с активным контролем) исследование с общим числом включенных пациентов 1307 человек и временным горизонтом 52 недели.…”

“…Результаты исследования выявили статистически значимое преимущество барицитиниба над адалимумабом по критерию эффективности ACR20. Второе исследование Keystone et al 2017 [11] [12], представлявшая собой комплексный обзор исследований фазы III, сравнивавшая тофацитиниб с адалимумабом, результатом которой был вывод о статистически значимом преимуществе тофицитиниба в эффективности по параметру ACR20: для адалимумаба -56,3; для тофацитиниба -60,7 (p < 0,0001). Наличие общего компаратора и критерия эффективности в исследованиях Taylor et al 2017 и Paul Bird et al 2018 позволило провести непрямое сравнение [13,14] барицитиниба (4 мг в сутки) и тофацитиниба (5 мг 2 раза в сутки).…”