title: A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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 (ACR20) at week 12. The secondary endpoints were change in Disease Activity Score of 28 joints - C-reactive protein (DAS28-CRP) and proportion of patients with an ACR50 and ACR70 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): ACR20 (82% vs. 79.2%; P > 0.7); ACR50 (46%, vs. 43.4%; P > 0.7); ACR70 (14% vs. 15.1%; P > 0.8). The change in DAS28-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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinical R & D, Cadila Healthcare Limited, The Zydus Group, Ahmedabad, India.
authors.forename: Rajendrakumar H
authors.initials: RH
authors.lastname: Jani
authors.affiliation: Malpani Multispecialty Hospital, Jaipur, India.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Medipoint Hospital Pvt. Ltd., Pune, India.
authors.forename: Girish
authors.initials: G
authors.lastname: Bhatia
authors.affiliation: Rathi Orthopaedic and Research Centre, Ahmedabad, India.
authors.forename: Gaurav
authors.initials: G
authors.lastname: Rathi
authors.affiliation: Department of Orthopedics, Unit-2 King George Hospital, Visakhapatnam, India.
authors.forename: Patnala
authors.initials: P
authors.lastname: Ashok Kumar
authors.affiliation: Shalby Hospital, Ahmedabad, India.
authors.forename: Reena
authors.initials: R
authors.lastname: Sharma
authors.affiliation: Clinical Immunology and Rheumatology Service, AIIMS, New Delhi, India.
authors.forename: Uma
authors.initials: U
authors.lastname: Kumar
authors.affiliation: SP Medical College & Associated Group of Hospitals, Bikaner, India.
authors.forename: Liyakat A
authors.initials: LA
authors.lastname: Gauri
authors.affiliation: Omkar Heart Institute & Nursing Home & Rheumatology Clinic, Nasik, India.
authors.forename: Praveen
authors.initials: P
authors.lastname: Jadhav
authors.affiliation: B J Medical College and Sassoon General Hospital, Pune, India.
authors.forename: Girishchandra
authors.initials: G
authors.lastname: Bartakke
authors.affiliation: Sushruta Multispecialty Hospital and Research Centre Pvt. Ltd., Vidyanagar, Hubli, India.
authors.forename: Vikram
authors.initials: V
authors.lastname: Haridas
authors.affiliation: DMC & Hospital, Ludhiana, India.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Jain
authors.affiliation: Clinical R & D, Cadila Healthcare Limited, The Zydus Group, Ahmedabad, India.
authors.forename: Sanjeev K
authors.initials: SK
authors.lastname: Mendiratta
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D012720:Severity of Illness Index; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D015415:Biomarkers; D059451:Biosimilar Pharmaceuticals; D002097:C-Reactive Protein; D000068879:Adalimumab
keywords: Exemptia; Humira; Zydus; adalimumab; biosimilar; rheumatoid arthritis