Article Text
Abstract
Objective To compare improvement in pain and physical function for patients treated with baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy from randomised, methotrexate (MTX)-controlled trials in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/biologic (bDMARD)-naïve RA patients using matching-adjusted indirect comparisons (MAICs).
Methods Data were from Phase III trials on patients receiving monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX. Pain was assessed using a visual analogue scale (0–100 mm) and physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI). An MAIC based on treatment-arm matching, an MAIC with study-level matching and Bucher’s method without matching compared change in outcomes between therapies. Matching variables included age, gender, baseline disease activity and baseline value of outcome measure.
Results With all methods, greater improvements were observed in pain and HAQ-DI at 6 months for baricitinib compared with adalimumab and tocilizumab (p<0.05). Differences in treatment effects (TEs) favouring baricitinib for pain VAS for treatment-arm matching, study-level matching and Bucher’s method, respectively, were −12, −12 and −12 for baricitinib versus adalimumab and −7, −7 and −9 for baricitinib versus tocilizumab; the difference in TEs for HAQ-DI was −0.28, −0.28 and −0.30 for adalimumab and −0.23, −0.23 and −0.26 for tocilizumab. For baricitinib versus tofacitinib, no statistically significant differences for pain improvement were observed except with one of the three methods (Bucher method) and none for HAQ-DI.
Conclusions Results suggest greater pain reduction and improved physical function for baricitinib monotherapy compared with tocilizumab and adalimumab monotherapy. No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.
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Footnotes
Correction notice This article has been corrected since it was published online. The open access licence of the article has been reinstated.
Contributors All authors participated in the interpretation of data, provided critical comments and input and reviewed and approved the final manuscript. B. Zhu, C. Nicolay and K. Kadziola additionally conducted the analyses.
Funding This study was funded by Eli Lilly and Company and Incyte Corporation.
Competing interests B. Fautrel: Grant/research support from: AbbVie, Lilly, MSD, Pfizer; Consultant and consultancy fees from: AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, SOBI, UCB; P.C. Taylor: Research grants from Celgene, Galapagos, Janssen, Lilly. Consultation fees from AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius and UCB. M. van de Laar: Grant/research support from: Abbvie; Eli Lilly and Company, Sanofi-Genzyme, Pfizer; Janssen-Cilag. Consultant and consulting fees for: Eli Lilly and Company, Sanofi Genzyme, Abbvie. P. Emery: Consultant and consulting fees for: Pfizer, MSD, Abbvie, BMS, UCB, Roche, Novartis, Samsung, Sandoz, Eli Lilly and Company. R. Fleischmann: Grant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Centrexion, Genetech, GlaxoSmithKline, Janssen, Eli Lilly and Company, Merck, Pfizer, Regeneron, Roche, Sanofi, Aventis, UCB; Consultant and consulting fees for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Celltrion, GSK, Janssen, Eli Lilly and Company, Novartis, Pfizer, Samsung, Sanofi-Aventis. B. Zhu, F. De Leonardis, C.L. Kannowski, C. Nicolay, Z. Kadziola, and I. De La Torre: employees and shareholders of Eli Lilly and Company.
Patient consent Not required.
Ethics approval Not applicable.
Data sharing statement Lilly provides access to relevant anonymised patient-level data from studies on approved medicines and indications as defined by the sponsor-specific information on clinicalstudydatarequest.com. For details on submitting a request, see the instructions provided at clinicalstudydatarequest.com.
Provenance and peer review Not commissioned; externally peer reviewed.