The nocebo effect challenges the non-medical infliximab switch in practice

N. W. Boone*, L. Liu, M. J. Romberg-Camps, L. Duijsens, C. Houwen, P. H. M. van der Kuy, R. Janknegt, R. Peeters, R. B. M. Landewe, B. Winkens, A. A. van Bodegraven

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of "first do no harm" may be challenged in a patient when switching from originator to biosimilar biological. Aim To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring. Methods Inflammatory bowel disease and rheumatology patients on infliximab originator were converted to infliximab biosimilar after providing informed consent. Nocebo response patients were monitored after switch back to originator. Linear mixed models were used to analyze continuous endpoints on effectiveness and laboratory outcomes to determine significance (P <= 0.05) of change over time after switching. Results After inviting 146 patients, a group of 125 patients enrolled in the project over time, respectively, 73 Crohn's disease, 28 ulcerative colitis, nine rheumatoid arthritis, ten psoriatic arthritis, and five ankylosing spondylitis patients. No statistically significant changes in effectiveness and safety were observed in any of the indications after a median of 4 infusions in 9 months of study. An overall nocebo response of 12.8% was found among the patients during a minimal observation period of 6 months after the transition to biosimilar infliximab. The overall nocebo response rate did not differ between the studied indications. Conclusions In inflammatory bowel disease and rheumatological patients, similar effectiveness and safety were demonstrated on the transition into infliximab biosimilar. In our series, patient empowerment and registration of treatment outcomes delineated biosimilar transition, an approach that hypothetically could reduce nocebo response rates which are relevant to account for regarding biosimilar implementation.
Original languageEnglish
Pages (from-to)655-661
Number of pages7
JournalEuropean Journal of Clinical Pharmacology
Volume74
Issue number5
DOIs
Publication statusPublished - 1 May 2018

Keywords

  • Inflammatory bowel disease
  • Crohn's disease
  • Ulcerative colitis
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Non-medical switch
  • Nocebo-effect
  • INFLAMMATORY-BOWEL-DISEASE
  • BIOSIMILAR CT-P13
  • ANKYLOSING-SPONDYLITIS
  • ORIGINATOR INFLIXIMAB
  • CLINICAL-OUTCOMES
  • DOUBLE-BLIND
  • ANTIBODIES
  • ARTHRITIS

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