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
Open Access
- 4 June 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Rheumatology
- Vol. 4 (1), 1-11
- https://doi.org/10.1186/s41927-020-00124-9
Abstract
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 (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints–C-reactive protein (DAS28-CRP), Health Assessment Questionnaire–Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints. 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], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of − 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [− 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported. 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.Keywords
This publication has 32 references indexed in Scilit:
- The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thingArthritis Research & Therapy, 2014
- 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease‐modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritisArthritis Care & Research, 2012
- The lifetime risk of adult-onset rheumatoid arthritis and other inflammatory autoimmune rheumatic diseasesArthritis & Rheumatism, 2010
- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugsAnnals Of The Rheumatic Diseases, 2010
- Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritisAnnals Of The Rheumatic Diseases, 2007
- Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trialAnnals Of The Rheumatic Diseases, 2007
- Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti–tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: A randomized, placebo‐controlled, 52‐week trialArthritis & Rheumatism, 2004
- Determinants of physical function in rheumatoid arthritis: association with the disease processRheumatology, 2003