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.

Abstract

BACKGROUND:

This 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.

METHODS:

In 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.

RESULTS:

Data 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.

CONCLUSIONS:

These 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 REGISTRATION:

ClinicalTrials.gov, NCT02187055. Registered on 08 July 2014.

• Authors: Tsutomu Takeuchi, Roy Fleischmann, Noriko Iikuni, Harry Shi, Koshika Soma, Jerome Paulissen, Tomohiro Hirose, Josef S Smolen
• Journal: Arthritis research & therapy (Arthritis Res Ther) Vol. 23 Issue 1 Pg. 220 (08 24 2021) ISSN: 1478-6362 [Electronic] England
• PMID: 34429160 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021. The Author(s).

Chemical References

• Antirheumatic Agents
• Piperidines
• Pyrimidines
• Pyrroles
• tofacitinib
• Adalimumab
• Methotrexate

Topics

• Adalimumab
• Antirheumatic Agents (therapeutic use)
• Drug Therapy, Combination
• Humans
• Methotrexate
• Piperidines
• Pyrimidines
• Pyrroles
• Treatment Outcome