Subjective Complaints as the Main Reason for Biosimilar Discontinuation After Open-Label Transition From Reference Infliximab to Biosimilar Infliximab

Autor: Alfons A den Broeder, Frank H J van den Hoogen, Iris L A van Ingen, Alphons J L de Jong, L. Tweehuysen, Willemijn H. van der Laan, Bart J F van den Bemt
Rok vydání: 2018
Předmět:
Adult
Male
musculoskeletal diseases
0301 basic medicine
medicine.medical_specialty
Immunology
Kaplan-Meier Estimate
Severity of Illness Index
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
Cohort Studies
03 medical and health sciences
Psoriatic arthritis
All institutes and research themes of the Radboud University Medical Center
0302 clinical medicine
Rheumatology
Internal medicine
Humans
Immunology and Allergy
Medicine
Prospective Studies
skin and connective tissue diseases
Prospective cohort study
Biosimilar Pharmaceuticals
BASDAI
Aged
030203 arthritis & rheumatology
Ankylosing spondylitis
Drug Substitution
business.industry
Arthritis
Hazard ratio
Antibodies
Monoclonal
Middle Aged
medicine.disease
Infliximab
Discontinuation
Surgery
C-Reactive Protein
Treatment Outcome
030104 developmental biology
Withholding Treatment
Antirheumatic Agents
Rheumatoid arthritis
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
Female
business
Follow-Up Studies
medicine.drug
Zdroj: Arthritis & Rheumatology, 70, 60-68
Arthritis & Rheumatology, 70, 1, pp. 60-68
ISSN: 2326-5191
Popis: Objective To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity, and safety in daily practice after transitioning treatment from original reference infliximab (Remicade [REM]) to a biosimilar infliximab (CT-P13 [Remsima; Inflectra]) in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Methods Of the initial 222 REM-treated patients, 192 agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Changes in the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and changes in the CRP levels, infliximab trough levels, and anti-infliximab antibody levels were assessed after 6 months, and adverse events (AEs) were documented. Drug survival and prognostic factors were analyzed using Kaplan-Meier and Cox regression analyses. Results During 6 months follow-up, 24% of the patients (n = 47) discontinued CT-P13. Thirty-seven patients restarted REM, 7 switched to another biologic drug, and 3 continued without a biologic drug. The DAS28-CRP remained stable from baseline to month 6, with a mean ± SD score of 2.2 ± 0.9 at baseline to 2.2 ± 0.8 at 6 months (difference of 0.0 [95% confidence interval (95% CI) -0.1, 0.2]). The BASDAI increased from a mean ± SD of 3.8 ± 2.0 at baseline to 4.3 ± 2.1 at 6 months (difference of +0.5 [95% CI 0.1, 0.9]). The CRP levels, infliximab trough levels, and anti-infliximab antibody levels did not change. Just prior to CT-P13 discontinuation, the DAS28-CRP components tender joint count and patient's global assessment of disease activity, as well as the BASDAI were increased compared to baseline. The most frequently reported AEs were arthralgia, fatigue, pruritus, and myalgia. A shorter REM infusion interval (hazard ratio: 0.77 [95% CI 0.62, 0.95]) at baseline was predictive of discontinuing CT-P13. Conclusion In our cohort, one-fourth of patients discontinued CT-P13 during 6 months of follow-up, mainly due to an increase in the subjective features of the tender joint count and the patient's global assessment of disease activity and/or subjective AEs, possibly explained by nocebo effects and/or incorrect causal attribution effects.
Databáze: OpenAIRE
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