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 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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Journal
AL-Kindy College Medical Journal
Published
2024-12-01
DOI
https://doi.org/10.47723/2km3dk27
Primary Topic
Biosimilars and Bioanalytical Methods
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article
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article

Iraqi Registry Data Proves Safety and Efficacy of switching to Adalimumab Biosimilar in Treating Rheumatoid Arthritis

Ali Younis, Mohammed H. Alosami, Nizar Abdulateef Jassim, Avin Maroof et al.
AL-Kindy College Medical Journal
Biosimilars and Bioanalytical Methods
article

Iraqi Registry Data Proves Safety and Efficacy of switching to Adalimumab Biosimilar in Treating Rheumatoid Arthritis

Ali Younis, Mohammed H. Alosami, Nizar Abdulateef Jassim, Avin Maroof, Nabaa Ihsan Awadh, Ali Alkazzaz, Faiq I. Gorial, Ali Hasan AlNoori, Marwa Moayad, Asal Adnan, Y Abbas, Mohammed Y Altahhan, Zahraa Almansi
article en

Abstract

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.

AL-Kindy College Medical JournalVol. 20(3)
University of Mosul (IQ), University of Baghdad (IQ), University of Babylon (IQ), Al Yarmouk University College (IQ), Baghdad Medical City (IQ), University of Kurdistan Hewler (IQ), Nahrain University (IQ)
Good health and well-being
Openalex Percentile: Top 72%
Biosimilars and Bioanalytical Methods
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