TY - JOUR
T1 - 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
AU - Safy-Khan, Mary
AU - Jacobs, Johannes W.G.
AU - De Hair, Maria J.H.
AU - Welsing, Paco M.J.
AU - Edwardes, Michael D.
AU - Teitsma, Xavier M.
AU - Luder, Yves
AU - Devenport, Jenny
AU - Van Laar, Jacob M.
AU - Pethoe-Schramm, Attila
AU - Bijlsma, Johannes W.J.
N1 - Funding Information:
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
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/4
Y1 - 2020/4
N2 - 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.
AB - 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.
KW - corticosteroids
KW - DMARDs (biologic)
KW - outcomes research
KW - rheumatoid arthritis
KW - Humans
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - Arthritis, Rheumatoid/drug therapy
KW - Treatment Outcome
KW - Glucocorticoids/therapeutic use
KW - Infections/chemically induced
KW - Randomized Controlled Trials as Topic
KW - Antirheumatic Agents/therapeutic use
KW - Adalimumab/therapeutic use
KW - Drug Therapy, Combination
KW - Methotrexate/therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=85079281577&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2019-216537
DO - 10.1136/annrheumdis-2019-216537
M3 - Article
C2 - 32033935
AN - SCOPUS:85079281577
SN - 0003-4967
VL - 79
SP - 460
EP - 463
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 4
M1 - 216537
ER -