Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy.

Autor:	Safy-Khan M; Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands marysafy@hotmail.com., Jacobs JWG; Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., de Hair MJH; Novartis Pharma BV, Amsterdam, The Netherlands., Welsing PMJ; Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Edwardes MD; Everest Clinical Research Canada, Markham, Ontario, Canada., Teitsma XM; F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland., Luder Y, Devenport J; F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland., van Laar JM; Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Pethoe-Schramm A; F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland., Bijlsma JWJ; Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.
Jazyk:	angličtina
Zdroj:	Annals of the rheumatic diseases [Ann Rheum Dis] 2020 Apr; Vol. 79 (4), pp. 460-463. Date of Electronic Publication: 2020 Feb 07.
DOI:	10.1136/annrheumdis-2019-216537
Abstrakt:	Background: In rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes. Objectives: To determine if inclusion of patients on background GC use influenced efficacy and safety outcomes of RA randomised clinical trials on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy. Methods: Data of four double-blind RA randomised controlled trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with in total four TCZ, one ADA and two MTX monotherapy arms were analysed. Analyses of covariance of changes from baseline to week 24 in efficacy endpoints and radiographic progression up to week 104 were performed, correcting for relevant covariates. Incidence rates of serious adverse events (SAEs) were assessed. Results: No statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm. SAE rates were not statistically significantly different between GC users and non-GC users in the treatment arms. Conclusion: No effect of including patients on background GC treatment on efficacy and safety trial outcomes was found, with the exception of reduced radiological joint damage in one MTX arm. Competing Interests: Competing interests: MS-K received a student grant from AstraZeneca. AstraZeneca was not involved in this study. AP-S, XT, YL and JD are employees of F Hoffmann-La Roche. MdH is an employee of Novartis. MDE is an employee of Everest Clinical Research. JWJB reported grants and fees form Roche, AbbvVie, Bristol-Myers, Squibb, Merck Sharp & Dohme, Pfizer and UCB. JMvL received fees from Arthrogen, MSD, Pfizer, Eli Lilly and BMS and research grants from Astra Zeneca and Roche-Genentech. JWGJ and PMJW report no competing interests. MJHdH is an employee of Novartis Pharma BV. Novartis Pharma BV was not involved in this study (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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