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
Abstract 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 Patients (n = 1...
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doaj-21f01bf2c5dd48bf9ae9be73c7e2fd342020-11-25T03:11:51ZengBMCBMC Rheumatology2520-10262020-06-014111110.1186/s41927-020-00124-9Comparative 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 therapyShubhadeep Sinha0Biswadip Ghosh1Syamasis Bandyopadhyay2Firdaus Fatima3Vamsi Krishna Bandi4Pankaj Thakur5Bala Reddy6Sreenivasa Chary7Leela Talluri8Ajay Gupta9Amit Ramchandra Kale10Anil Kumar Gupta11Ashok Kumar P12Diwakar Reddy13Younus Mohammed14Soma Shekar15Sudheer T16Vijay G. Goni17Vishnu Sharma18Vishwanath Yeligod19Hetero Biopharma LimitedDepartment of Rheumatology, Institute of Post Graduate Medical Education & Research & SSKM HospitalApollo Gleneagles HospitalsVasavi Medical & Research CentreHetero Biopharma LimitedHetero Biopharma LimitedHetero Biopharma LimitedHetero Biopharma LimitedHetero Biopharma LimitedOpp. MLB Medical College, Nirmal HospitalB. J. Medical College, Sassoon General HospitalGSVM Medical CollegeAndhra Medical College, Department of Orthopedics, King George HospitalSt.Theresa’s Hospital ErragaddaM.Jeevan Jyoti Multispecialty hospital & Infertility Research CentreGurushree Hi-Tech Multi speicality Hopsital No.1558 Opp. Chandra layout Bus Stand Chandra Layout VijaynagarDepartment of Orthopedics, Rajiv Gandhi Insititute of Medical Sciences & RIMS Government General HospitalDepartment of orthopedic surgery, Post graduate institute of medical education & ResearchB.J. Medical College, Civil HospitalSapthagiri Institute of Medical Sciences and Research Center #15Abstract 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 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. 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], 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. Conclusion 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 CTRI/2016/04/006884 , Registered on 28/04/2016.http://link.springer.com/article/10.1186/s41927-020-00124-9RheumatologyAdalimumabMethotrexateAntirheumatic agents |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Shubhadeep Sinha Biswadip Ghosh Syamasis Bandyopadhyay Firdaus Fatima Vamsi Krishna Bandi Pankaj Thakur Bala Reddy Sreenivasa Chary Leela Talluri Ajay Gupta Amit Ramchandra Kale Anil Kumar Gupta Ashok Kumar P Diwakar Reddy Younus Mohammed Soma Shekar Sudheer T Vijay G. Goni Vishnu Sharma Vishwanath Yeligod |
spellingShingle |
Shubhadeep Sinha Biswadip Ghosh Syamasis Bandyopadhyay Firdaus Fatima Vamsi Krishna Bandi Pankaj Thakur Bala Reddy Sreenivasa Chary Leela Talluri Ajay Gupta Amit Ramchandra Kale Anil Kumar Gupta Ashok Kumar P Diwakar Reddy Younus Mohammed Soma Shekar Sudheer T Vijay G. Goni Vishnu Sharma Vishwanath Yeligod 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 BMC Rheumatology Rheumatology Adalimumab Methotrexate Antirheumatic agents |
author_facet |
Shubhadeep Sinha Biswadip Ghosh Syamasis Bandyopadhyay Firdaus Fatima Vamsi Krishna Bandi Pankaj Thakur Bala Reddy Sreenivasa Chary Leela Talluri Ajay Gupta Amit Ramchandra Kale Anil Kumar Gupta Ashok Kumar P Diwakar Reddy Younus Mohammed Soma Shekar Sudheer T Vijay G. Goni Vishnu Sharma Vishwanath Yeligod |
author_sort |
Shubhadeep Sinha |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Rheumatology |
issn |
2520-1026 |
publishDate |
2020-06-01 |
description |
Abstract 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 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. 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], 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. Conclusion 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 CTRI/2016/04/006884 , Registered on 28/04/2016. |
topic |
Rheumatology Adalimumab Methotrexate Antirheumatic agents |
url |
http://link.springer.com/article/10.1186/s41927-020-00124-9 |
work_keys_str_mv |
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