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 |
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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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