Iraqi Registry Data Proves Safety and Efficacy of switching to Adalimumab Biosimilar in Treating Rheumatoid Arthritis
Background: Adalimumab is approved for Rheumatoid Arthritis (RA). In 2021, A biosimilar (ABP501;Amgevita®) was licensed in Iraq. The current study aimed to ensure safety and Efficacy of Amgevita in RA Patients in Iraq. Patients and Methods: A Cross sectional Observational study Started on 69...
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| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
University of Baghdad/ Al-Kindy College of Medicine
2024-12-01
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| Series: | مجله كليه طب الكندي |
| Subjects: | |
| Online Access: | https://jkmc.uobaghdad.edu.iq/index.php/MEDICAL/article/view/1476 |
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| Summary: |
Background: Adalimumab is approved for Rheumatoid Arthritis (RA). In 2021, A biosimilar (ABP501;Amgevita®) was licensed in Iraq. The current study aimed to ensure safety and Efficacy of Amgevita in RA Patients in Iraq.
Patients and Methods: A Cross sectional Observational study Started on 69 RA Records receiving Amgevita. Data collected from local registry then examined for disease activity and adverse reactions for 9 months follow up.
Results: Thirty patients completed the 9 months period of the study: aged (49±14) years; 77.5% females. After 3, 6 and 9 months of follow up, patients' mean (SD) CDAI 27.8 ( 13.60 ) which was statistically lower (19.80) (6.96), 17.70 (2.790), and 19 (1.040), p<0.001. With a mean change of CDAI: 8 (p<0.001), 10.1 (p<0.001), and 8.78 (p<0.001) after 3, 6, and 9 months. Cumulative percentage of responders was 55.00% and Cumulative percentage of probability of change of disease activity was 86.00%, No patient achieved remission and no significant Side effects recorded. In conclusion Amgevita is Effective and Safe in RA.
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| ISSN: | 1810-9543 2521-4365 |