P127 Baricitinib Efficacy in Moderate Rheumatoid Arthritis - A Post-hoc Analysis from two Phase III Trials
Authors: Kirkham Bruce W , Nikiphorou Elena , Edwards Christopher J , Sheesh Mohamed , Haladyj Ewa , Gerwien Jens , Zaremba-Pechmann Liliana , Taylor Peter C 
Published: April 2023

Background/Aims

Baricitinib, an oral selective JAK 1/2 inhibitor, is approved for treating adults with moderate-to-severe active rheumatoid arthritis (RA). This analysis aims to report the efficacy of baricitinib in patients with moderate RA at weeks (W)12 and 24 from two phase III studies, RA-BEAM (NCT01710358) and RA-BUILD (NCT01721057).

Methods

This post-hoc analysis included patients from RA-BEAM (inadequate responders to methotrexate) and RA-BUILD (inadequate responders to conventional synthetic DMARDs) with moderate RA at baseline (defined as Disease Activity Score (DAS)-28 with C-reactive protein (CRP) of &gt; 3.2 and ≤5.1). This analysis reports treatment response as low disease activity (LDA) defined by DAS28-CRP ≤3.2 and &gt;2.6 or remission defined by &lt; 2.6 and presents descriptive data at W12 and W24, including pain (visual analogue scale [VAS]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), physical functioning (Health Assessment Questionnaire-Disability Index [HAQ-DI]), Work Productivity and Activity Impairment (WPAI), duration and severity of morning stiffness, joint pain, and fatigue using daily diaries. Continuous variables are presented as median with interquartile range and categorical variables as frequencies and percentages.

Results

At baseline, moderate RA was observed in 117 patients on baricitinib 4-mg, 80 on adalimumab, and 133 on placebo in RA-BEAM; and 80 on baricitinib 2-mg, 63 on baricitinib 4-mg, and 73 on placebo in RA-BUILD. In RA-BEAM at W12, 46.2%, 37.5%, and 9.0% of patients on baricitinib 4-mg, adalimumab, and placebo, respectively, achieved remission. In RA-BUILD at W12, 38.8%, 44.4%, and 13.7% of patients on baricitinib 2-mg, baricitinib 4-mg, and placebo, respectively, achieved remission. At W24, a further increase in the percentage of patients achieving remission was reported in both trials (Table). Improvement in pain (VAS), FACIT-F, and HAQ-DI was similar across RA-BEAM and RA-BUILD with baricitinib treatment (Table). In both trials, patients reported improvement in duration and severity of morning stiffness, worst tiredness, and worst joint pain with baricitinib treatment (Table). Additionally, baricitinib treatment yielded numerical improvement in impairment of daily activity and work productivity in RA-BEAM (Table).

Conclusion

In patients with moderate RA, baricitinib markedly improved signs and symptoms of RA and patient-reported outcomes (PROs) at W12 and W24.

Disclosure

B.W. Kirkham: Member of speakers’ bureau; B.K. has received speaker’s payments from AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB. Grants/research support; B. K. has received research support from Eli Lilly and Company and Novartis. Other; B. K. has been an adviser for AbbVie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, and UCB. B. W. has received meeting support payments from Eli Lilly and Company. E. Nikiphorou: Honoraria; E.N. received speaker honoraria from Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly and Company, and Fresenius. Grants/research support; E.N. holds grants from Pfizer and Eli Lilly and Company. Other; E.N. participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly and Company, and Fresenius. E. N. received travel payments from Eli Lilly and Company. C.J. Edwards: Honoraria; C.E received honoraria from Eli Lilly and Company. Grants/research support; C.E. received grant payments from Abbvie, Pfizer, Roche, Biogen, and Eli Lilly and Company. Other; C.E. received personal fees from Abbvie, Astra-Zeneca, BMS, Celltrion, Fresenius, Galapagos, Gilead, GSK, Janssen, Roche, Pfizer, and Sanofi and travel and meeting payments from Eli Lilly and Company. M. Sheesh: Corporate appointments; M. S. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; M. S. is a minor shareholder at Eli Lilly and Company. E. Haladyj: Corporate appointments; E. H. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; E. H. is a minor shareholder at Eli Lilly and Company. J. Gerwien: Corporate appointments; J. G. is a full-time employee at Eli Lilly and Company. Shareholder/stock ownership; J. G. is a minor shareholder at Eli Lilly and Company. L. Zaremba-Pechmann: Corporate appointments; L. Z-P is a contractor at HaaPACS gmbH. P.C. Taylor: Consultancies; P. T. has been a consultant for AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli Lilly and Company, BMS, Pfizer, Roche, Celltrion, Sanofi, Nordic Pharma, Fresenius, and UCB. Grants/research support; P. T. received grant/research support from Galapagos. Other; P. T. has received meeting support payments from Eli Lilly and Company.