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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
  1. Mary Safy-Khan1,
  2. Johannes W G Jacobs1,
  3. Maria J H de Hair2,
  4. Paco M J Welsing1,
  5. Michael D Edwardes3,
  6. Xavier M Teitsma4,
  7. Yves Luder,
  8. Jenny Devenport4,
  9. Jacob M van Laar1,
  10. Attila Pethoe-Schramm4,
  11. Johannes W J Bijlsma1
  1. 1Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
  2. 2Novartis Pharma BV, Amsterdam, The Netherlands
  3. 3Everest Clinical Research Canada, Markham, Ontario, Canada
  4. 4F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland
  1. Correspondence to Mary Safy-Khan, Rheumatology and Clinical Immunology, UMC Utrecht, 3584 CX Utrecht, The Netherlands; marysafy{at}hotmail.com

Abstract

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.

  • rheumatoid arthritis
  • DMARDs (biologic)
  • corticosteroids
  • outcomes research
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Footnotes

  • Handling editor Josef S Smolen

  • Contributors MS-K, JWGJ, AP-S and JWJB contributed to the study design. MS-K, AP-S, YL, MDE and JWGJ contributed to data collection. All authors had full access to the study data, contributed to data analysis, data interpretation, writing and review of the manuscript and approved the final version for publication.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • 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

  • Patient consent for publication Not required.

  • Ethics approval Medical ethical approval was not required for this post hoc study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request at the Roche coauthors.

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