Brouwer, Rianne (2020) Switch van biological (Humira®) naar biosimilar (Amgevita®) bij patiënten met reumatoïde artritis Is het veilig? Is het effectief? En zijn patiënten tevreden? thesis, Medicine.
Full text available on request.Abstract
Introduction: Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease in which sterile inflammatory reactions in the synovia develop symmetrically, especially in the small, distal joints of the extremities. Biologicals have helped to ensure that RA can be treated better, but at increasing healthcare costs. With the expiration of the patents of biologicals, space is becoming available for the so-called biosimilars, which have practically equivalent physical, chemical and biological qualities as the original (originator) biologicals, however these medicines are usually much cheaper. The aim of this study is to investigate during a switch for economic reasons, whether the effectiveness and safety of the adalimumab biosimilar Amgevita®, a subcutaneous TNF-inhibitor, is equivalent to that of the adalimumab originator Humira® and whether patients are satisfied with the switch from Humira® to Amgevita®. Methods: A single center retrospective observational study of RA patients on the course of their disease activity (DAS28), quality of life (SF36), physical functioning (HAQ) and parameters of inflammation (BSE, CRP) 3, 6, 9 and 12 months before, during, and 3, 6, 9 and 12 months after the switch from Humira® to Amgevita®, supplemented with a crossectional survey on patient satisfaction and experienced side effects. Normally distributed variables were analyzed by linear mixed modelling. Variables which were not normally distributed were dichotomized and analyzed by generalized estimation equations. Results: On November 1st 2018, 239 patients at the department of rheumatology who were using Humira® switched, after being fully informed, from Humira® to Amgevita®. Of 52/239 (21.8%) of these patients, sufficient data were available for analysis and met the inclusion criteria. The average score of the DAS28 at baseline was 2.25 (± 0.81). The mean DAS28 at 3, 6, 9 and 12 months after the switch did not differ significantly from the baseline. The SF36 scores, HAQ-DI scores, BSE and CRP measurements and the percentage of patients in remission did not show significant differences from baseline either. 38 of the 52 patients (73.1%) returned the questionnaire. Overall, patients were satisfied with the switch. Three patients discontinued Amgevita® due to side effects. Conclusion: In patients with RA, switching from the originator adalimumab Humira® to the biosimilar adalimumab Amgevita® for economic reasons did not increase disease activity or impairments in physical function and did not decrease quality of life over an observation period of 12 months. Also, there was no evidence of increased side effects. Patients themselves were mostly satisfied with the switch.
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Vonkeman, Dr. H.E. and ten Klooster, Dr. P.M. |
| Faculty: | Medical Sciences |
| Date Deposited: | 05 Sep 2023 11:20 |
| Last Modified: | 05 Sep 2023 11:20 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/3670 |
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