Article Text
Abstract
Objective To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a real-life treat-to-target (T2T) setting.
Methods Patients with biological and targeted synthetic DMARD (b/tsDMARD) naïve RA with disease duration ≤5 years without contraindications to b/tsDMARD were randomised to either TNFi or baricitinib when csDMARD failed to achieve disease control in a T2T setting. Changes in clinical and patient-reported outcome measures (PROMs) were assessed at 12-week intervals for 48 weeks. The primary endpoint was non-inferiority, with testing for superiority if non-inferiority is demonstrated, of baricitinib strategy in the number of patients achieving American College of Rheumatology 50 (ACR50) response at 12 weeks. Secondary endpoints included 28-joint count Disease Activity Score with C reactive protein (DAS28-CRP) <2.6, changes in PROMs and radiographic progression.
Results A total of 199 patients (TNFi, n=102; baricitinib, n=97) were studied. Both study groups were similar. Baricitinib was both non-inferior and superior in achieving ACR50 response at week 12 (42% vs 20%). Moreover, 75% of baricitinib patients achieved DAS28-CRP <2.6 at week 12 compared with 46% of TNFi patients. On secondary outcomes throughout the duration of the study, the baricitinib strategy demonstrated comparable or better outcomes than TNFi strategy. Although not powered for safety, no unexpected safety signals were seen in this relatively small group of patients.
Conclusion Up to present, in a T2T setting, patients with RA failing csDMARDs have two main strategies to consider, Janus Kinases inhibitor versus bDMARDs (in clinical practice, predominantly TNFi). The PERFECTRA study suggested that starting with baricitinib was superior over TNFi in achieving response at 12 weeks and resulted in improved outcomes across all studied clinical measures and PROMs throughout the study duration in these patients.
- Adalimumab
- Arthritis, Rheumatoid
- Biological Therapy
- Patient Reported Outcome Measures
- Tumor Necrosis Factor Inhibitors
Data availability statement
Data are available upon reasonable request. Data are available upon reasonable request. Underlying data from this manuscript may be requested by qualified researchers. Investigators may request access to anonymised individual patient-level data and/or (redacted) trial documents. Prior to use of the data, proposals need to be approved by the PERFECTRA study group and a signed data sharing agreement will need to be executed. Requests can be made via the corresponding author.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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- Adalimumab
- Arthritis, Rheumatoid
- Biological Therapy
- Patient Reported Outcome Measures
- Tumor Necrosis Factor Inhibitors
Data availability statement
Data are available upon reasonable request. Data are available upon reasonable request. Underlying data from this manuscript may be requested by qualified researchers. Investigators may request access to anonymised individual patient-level data and/or (redacted) trial documents. Prior to use of the data, proposals need to be approved by the PERFECTRA study group and a signed data sharing agreement will need to be executed. Requests can be made via the corresponding author.
Supplementary materials
Supplementary Data
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Footnotes
Contributors Study conception and design: MvdL, MAHOV, PtK, DIT and CJvdL. Data collection: DIT, RB, TJ, AW, GAV, YPMG-R and E-JK. Formal analysis: all authors. Writing (original draft): CJvdL, MAHOV and MVdL. Guarantor: CJvdL, MvdL. Writing (revising, review and editing): all authors. All authors read and approved the final manuscript.
Competing interests CJvdL, MAHOV, PtK, DIT and MVdL report that the Investigator Initiated Study PERFECTRA was financially supported by an unrestricted grant by Eli Lilly. MVdL reports speaker fees by Eli Lilly and Galapagos. RB reports a research grant from Galapagos, advisory board payments from Janssen-Cilag bv, Galapagos, and Abbvie bv, payment for chairing an educational event from Janssen-Cilag bv.
Patient and public involvement statement Patients were involved in the design of PERFECTRA. The Dutch patient association ‘Nationale Vereniging ReumaZorg Nederland (RZN)’ was involved with design of the study protocol and were consulted on design and feasibility.
Provenance and peer review Not commissioned; externally peer reviewed.
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