In:
International Journal of Rheumatic Diseases, Wiley, Vol. 19, No. 11 ( 2016-11), p. 1157-1168
Abstract:
In this study, efficacy, tolerability and safety of biosimilar adalimumab (Exemptia; Zydus Cadila) was compared with reference adalimumab (Humira; AbbVie) in patients with moderate to severe rheumatoid arthritis ( RA ). Method In this multicentre, prospective, randomized, double‐blind, active controlled parallel arm study, 120 patients with moderate to severe RA were given 40 mg of either test adalimumab (Exemptia) or reference adalimumab (Humira) by subcutaneous route every other week for 12 weeks. The primary endpoint was proportion of responders in two tretament groups by American College of Rheumatology 20 ( ACR 20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints – C‐reactive protein ( DAS 28‐ CRP ) and proportion of patients with an ACR 50 and ACR 70 response in two treatment groups at week 12. Safety outcomes were also assessed. Results After 12 weeks, patients treated every other week with test adalimumab (Zydus Cadila) had statistically similar response rates as compared to reference adalimumab (AbbVie): ACR 20 (82% vs . 79.2%; P 〉 0.7); ACR 50 (46%, vs . 43.4%; P 〉 0.7); ACR 70 (14% vs . 15.1%; P 〉 0.8). The change in DAS 28‐ CRP score was −2.1 ± 1.09 and −2.1 ± 1.21, in test and reference products, respectively. It was statistically significant compared to baseline, but not significantly different between the two products. Three serious adverse events and no death was reported during the study. Both adalimumab preparations were safe and well tolerated in this study. Conclusion The results demonstrated biosimilarity with respect to efficacy, tolerability and safety of test adalimumab (Exemptia) and reference adalimumab (Humira) in patients with moderate to severe RA .
Type of Medium:
Online Resource
ISSN:
1756-1841
,
1756-185X
DOI:
10.1111/apl.2016.19.issue-11
DOI:
10.1111/1756-185X.12711
Language:
English
Publisher:
Wiley
Publication Date:
2016
detail.hit.zdb_id:
2427877-4
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