Differences and similarities in clinical and functional responses among patients receiving tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate: a post hoc analysis of data from ORAL Strategy

Arthritis Research & Therapy

Josef S. Smolen¹  Tsutomu Takeuchi²  Koshika Soma³  Harry Shi⁴  Noriko Iikuni⁴  Jerome Paulissen⁴  Tomohiro Hirose⁵  Roy Fleischmann⁶ 

[1] Division of Rheumatology and Department of Medicine 3, Medical University of Vienna, Vienna, Austria;Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan;Pfizer Inc, Groton, CT, USA;Pfizer Inc, New York, NY, USA;Pfizer Japan Inc, Shinjuku Bunka Quint Building 22F, 3-22-7, Yoyogi, 151-8589, Shibuya-ku, Tokyo, Japan;Rheumatology Division, Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA;

关键词: Adalimumab;    Methotrexate;    Rheumatoid arthritis;    Tofacitinib;   

DOI  :  10.1186/s13075-021-02591-y

来源: Springer

【 摘 要 】

BackgroundThis post hoc analysis assessed clinical and functional responses to tofacitinib monotherapy, tofacitinib + methotrexate (MTX), and adalimumab + MTX, in patients with rheumatoid arthritis enrolled in the ORAL Strategy study, including evaluation of patient-level data using cumulative probability plots.MethodsIn the 12-month, phase IIIb/IV ORAL Strategy study, patients with rheumatoid arthritis and an inadequate response to MTX were randomized to receive tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID + MTX, or adalimumab 40 mg every other week + MTX. In this post hoc analysis, cumulative probability plots were generated for mean percent change from baseline (%∆) in the Clinical Disease Activity Index (CDAI; clinical response) and mean change from baseline (∆) in the Health Assessment Questionnaire-Disability Index (HAQ-DI; functional response) at month 12. Median C-reactive protein (CRP) levels by time period were summarized by CDAI remission (≤ 2.8) status at months 6 and 12.ResultsData for 1146 patients were analyzed. At month 12, cumulative probability plots for %∆CDAI and ∆HAQ-DI were similar across treatments in patients with greater response. At lower levels of response, patients receiving tofacitinib monotherapy did not respond as well as those receiving combination therapies. With tofacitinib + MTX, numerically higher baseline CRP levels and numerically larger post-baseline CRP reductions were seen in patients achieving CDAI remission at months 6 and 12 vs those who did not.ConclusionsThese results suggest that patients with a greater response did well, irrespective of which therapy they received. Patients with lesser response had better outcomes with combination therapies vs tofacitinib monotherapy, suggesting they benefitted from MTX. High pre-treatment CRP levels may be associated with better response to tofacitinib + MTX.Trial registrationClinicalTrials.gov, NCT02187055. Registered on 08 July 2014.

【 授权许可】

CC BY