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The results of investigating the efficacy and safety of non-medical switching from the original rituximab to its biosimilar in rheumatoid arthritis patients (AMBIRA study)
- Source :
- Научно-практическая ревматология, Vol 58, Iss 6, Pp 663-672 (2021)
- Publication Year :
- 2021
- Publisher :
- IMA-PRESS LLC, 2021.
-
Abstract
- Wide usage of biologic disease-modifying anti-rheumatic drugs (DMARDs) biosimilars in clinical practice has greatly increased the availability of biologic therapy for rheumatic patients. Nevertheless, not only economic expediency but efficacy and safety are the key principals of any treatment including biologic DMARDs. Objective . To investigate the efficacy and safety of switching from the original rituximab (MabThera®, “F. Hoffmann-La Roche Ltd.”, Switzerland) to its biosimilar (Acellbia®, “BIOCAD”, Russia) by non-medical reasons in rheumatoid arthritis patients. Subjects and methods . 40 rheumatoid arthritis patients on basic therapy who had taken at least one course of original rituximab (MabThera®) 1000 mg twice in 2 weeks more than 6 months ago were included. They were switched to equal-dose biosimilar (Acellbia®) by non-medical reasons and were observed throughout the year. At 12, 24 weeks and one year after switching dynamics of the next parameters were evaluated: pain level according to visual analogue scale (VAS), tender joint count (TJC), swollen joint count (SJC), acute inflammatory and immunological markers, disease activity score (DAS28) calculated using erythrocyte sedimentation rate (DAS28-ESR) or C-reactive protein (DAS28-CRP), health assessment questionnaire (HAQ) index and safety profile. Results . All the data are presented as median of indicator in the moment of measurement after switching therapy (Meperiod). In 12-week period TJC [(Me]_0=9.50, Me_12=6.0, p< 0.01) and SJC (Me_0=2,0, Me_12=1,0, p
- Subjects :
- musculoskeletal diseases
rheumatoid arthritis
medicine.medical_specialty
Visual analogue scale
Immunology
Diseases of the musculoskeletal system
Gastroenterology
rituximab
Rheumatology
Pain level
Internal medicine
medicine
Immunology and Allergy
Rheumatoid factor
Therapy efficacy
medicine.diagnostic_test
business.industry
medicine.disease
Safety profile
RC925-935
Erythrocyte sedimentation rate
Rheumatoid arthritis
Rituximab
biosimilar
business
medicine.drug
Subjects
Details
- Language :
- Russian
- ISSN :
- 19954492 and 19954484
- Volume :
- 58
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Научно-практическая ревматология
- Accession number :
- edsair.doi.dedup.....433dbd3e8742bdaf14a695c12e55c018