Background Achieving remission is the ideal goal in treating rheumatoid arthritis (RA). In a randomised phase 3 trial, high remission and low disease activity (LDA) rates were achieved with baricitinib (BARI). However, little is known about the differences in patient reported outcomes (PROs) among patients (pts) who have already achieved these targets.
Objectives To compare PROs between BARI, adalimumab (ADA), and placebo (PBO) in pts with RA who achieved LDA or remission in the Phase 3 RA-BEAM study.
Methods 1305 pts with RA and background treatment with methotrexate were randomised to receive PBO (n=488), ADA (n=330), or BARI 4 mg (n=487) for 52 wks (24 wks for PBO). In each treatment group, pts in remission (DAS28-ESR<2.6) and with LDA (DAS28-ESR≤3.2) at wk 24 were assessed from baseline for the following PROs: Pain VAS, HAQ-DI, WPAI, Morning Joint Stiffness (MJS), and FACIT-F. Sensitivity analyses were conducted for pts in remission or LDA by DAS28-CRP, SDAI, or CDAI. The assessment of response at wk 24 was determined by using the observed data, and the missing values for PRO measures were imputed by using mLOCF.
Results Among pts in LDA, significantly greater improvements in Pain VAS and HAQ-DI scores were observed with BARI than ADA and PBO, and significantly greater improvements in MJS were observed with BARI and ADA than PBO. Significantly greater residual pain and HAQ-DI scores were observed with PBO. Among pts in remission, significantly greater improvements in pain and HAQ-DI scores were also observed with BARI than PBO. Patients in remission or LDA showed greater numerical improvement and less residual impairment in other PROs with BARI and ADA than PBO (Table 1). Consistent results were observed using other composite measures to define LDA and remission.
Conclusions The preliminary findings from this study suggest that BARI showed greater improvements in pain and HAQ-DI compared to ADA for pts in LDA, and greater improvements in pain and HAQ-DI scores as well as less physical impairment compared to PBO for pts in LDA and remission.
Acknowledgements The authors acknowledge the contribution of Inmaculada de la Torre MD, PhD, Senior Medical Advisor.
Disclosure of Interest B. Fautrel: None declared, M. van de Laar: None declared, B. Kirkham: None declared, R. Alten Consultant for: Eli Lilly and Company, R. Cseuz Consultant for: Eli Lilly and Company, S. Van der Geest Employee of: Eli Lilly and Company, B. Zhu Employee of: Eli Lilly and Company, F. De Leonardis Employee of: Eli Lilly and Company, P. Taylor Consultant for: Eli Lilly and Company; Abvie