Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy.
Adalimumab
Antirheumatic agents
Methotrexate
Rheumatology
Journal
BMC rheumatology
ISSN: 2520-1026
Titre abrégé: BMC Rheumatol
Pays: England
ID NLM: 101738571
Informations de publication
Date de publication:
2020
2020
Historique:
received:
28
11
2019
accepted:
18
03
2020
entrez:
11
6
2020
pubmed:
11
6
2020
medline:
11
6
2020
Statut:
epublish
Résumé
Our study aimed to compare efficacy and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy. Patients ( Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [- 6.0, 6.0], Results demonstrated Hetero's adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy. CTRI/2016/04/006884, Registered on 28/04/2016.
Sections du résumé
BACKGROUND
BACKGROUND
Our study aimed to compare efficacy and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy.
METHODS
METHODS
Patients (
RESULTS
RESULTS
Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [- 6.0, 6.0],
CONCLUSION
CONCLUSIONS
Results demonstrated Hetero's adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy.
TRIAL REGISTRATION
BACKGROUND
CTRI/2016/04/006884, Registered on 28/04/2016.
Identifiants
pubmed: 32518895
doi: 10.1186/s41927-020-00124-9
pii: 124
pmc: PMC7271501
doi:
Types de publication
Journal Article
Langues
eng
Pagination
24Informations de copyright
© The Author(s) 2020.
Déclaration de conflit d'intérêts
Competing interestsSS, BR, VKB, SC, PT, and LT are the employees of Hetero Biopharma Limited, India and involved from conception of study to the approval of the manuscript. All the authors declare no other competing interests.
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