PT  - JOURNAL ARTICLE
AU  - Peter C. Taylor
AU  - Rieke Alten
AU  - Jose María Álvaro Gracia
AU  - Yuko Kaneko
AU  - Chad Walls
AU  - Amanda Quebe
AU  - Bochao Jia
AU  - Natalia Bello
AU  - Jorge Ross Terres
AU  - Roy Fleischmann
TI  - Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy
AID  - 10.1136/rmdopen-2021-001994
DP  - 2022 Mar 01
TA  - RMD Open
PG  - e001994
VI  - 8
IP  - 1
4099  - http://rmdopen.bmj.com/content/8/1/e001994.short
4100  - http://rmdopen.bmj.com/content/8/1/e001994.full
SO  - RMD Open2022 Mar 01; 8
AB  - Objectives This post hoc analysis assessed speed, magnitude and maintenance of pain improvement in patients with early rheumatoid arthritis (RA) receiving baricitinib, baricitinib and methotrexate (MTX), or MTX over 1 year. Cumulative pain and quality of life benefits were also assessed.Methods Randomised, double-blind, phase 3 study RA-BEGIN (NCT01711359) compared baricitinib 4 mg (N=159), baricitinib 4 mg +MTX (N=215) and MTX (N=210) in patients with RA who had no or limited prior disease-modifying antirheumatic drug treatment. Pain was assessed on a 0–100 mm Visual Analogue Scale (VAS). Proportion of patients with ≥30%, ≥50% and ≥70% pain improvement from baseline; ≤20 mm and ≤10 mm on the pain VAS; and time to achieve pain improvement thresholds were assessed over 52 weeks, as were Patient Global Assessment (PtGA) and 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS) outcomes.Results Baricitinib monotherapy or combination with MTX provides greater (least square mean changes (LSM) from baseline −40 mm and −43 mm, respectively) and more rapid (median 12 and 8 weeks to ≥70% improvement, respectively) pain relief than MTX alone (LSM −31 mm, median 20 weeks to ≥70% improvement) over 52 weeks. Baricitinib, alone or combination, provides 9–10 additional weeks of limited to no pain, similar gain in achievable wellness measured through PtGA, and 5–7 additional weeks with change in SF-36 PCS ≥5 vs MTX over 1 year.Conclusions Patients treated with baricitinib reported significantly greater and more rapid pain relief, more weeks with limited to no pain, and clinically meaningful improvements in physical health than patients treated with MTX alone over 1 year.Data are available on reasonable request. Lilly provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.