title: Efficacy and safety of golimumab in Indian patients with rheumatoid arthritis: Subgroup data from GO-MORE study.
abstract: OBJECTIVE
  To conduct a subgroup analysis of GO-MORE trial Part 1, comparing efficacy and safety of add-on subcutaneous golimumab therapy in rheumatoid arthritis (RA) patients enrolled from and outside India.
  
  
  METHODS
  GO-MORE was an open-label, multicenter, prospective trial of add-on golimumab in biologic-naïve RA patients, having active disease despite being on conventional DMARD regimen(s). Part 1 of the study was chosen as the focus of this subgroup analysis because a substantial number of Indian patients (106) were enrolled compared to no Indian patients in Part 2. The primary efficacy outcome was proportion of patients achieving good to moderate DAS28-ESR (Disease Activity Score of 28 joints calculated using erythrocyte sedimentation rate) European League Against Rheumatism (EULAR) response at month 6.
  
  
  RESULTS
  Efficacy evaluable population comprised of 105 and 3175 patients from India and outside India, respectively. Safety analysis included 106 patients enrolled from India and 3251 from outside India. A higher proportion of Indian patients had a high disease activity as measured by DAS28 ESR than outside India patients. At month 6, the proportion of Indian and non-Indian patients achieving DAS28-ESR, DAS28 - C-reactive protein, simplified disease activity index (SDAI) remission, and EuroQoL Quality-of-Life Questionnaire (EQ-5D) scores were comparable. Incidence of all adverse events was lower in Indian patients. There were no deaths, cases of tuberculosis or malignancy reported in the patients from India at month 6.
  
  
  CONCLUSIONS
  The efficacy and safety results with add-on golimumab were consistent between RA patients from India and outside India, despite high baseline disease activity in the Indian patients.
authors.affiliation: Advance Rheumatology Clinic, Hyderabad, India.
authors.forename: Sarvajeet
authors.initials: S
authors.lastname: Pal
authors.affiliation: Krishna Institute of Medical Sciences, Secunderabad, India.
authors.forename: Sarath Chandra Mouli
authors.initials: SC
authors.lastname: Veeravalli
authors.affiliation: Department of Rheumatology, RALC Campus, King George's Medical University, Lucknow, India.
authors.forename: Siddharth Kumar
authors.initials: SK
authors.lastname: Das
authors.affiliation: St. John's Medical College Hospital, Bangalore, India.
authors.forename: Vineeta
authors.initials: V
authors.lastname: Shobha
authors.affiliation: Sri Deepti Rheumatology Centre, Hyderabad, India.
authors.forename: Ramakrishna Rao
authors.initials: RR
authors.lastname: Uppuluri
authors.affiliation: Chanre Rheumatology and Immunology Center and Research, Bangalore, India.
authors.forename: B G
authors.initials: BG
authors.lastname: Dharmanand
authors.affiliation: Department of Medicine, Seth G.S. Medical College & KEM Hospital, Mumbai, India.
authors.forename: Milind
authors.initials: M
authors.lastname: Nadkar
authors.affiliation: Janssen Global R&D, J&J, Spring House, PA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hsia
authors.affiliation: Janssen Global R&D, J&J, Spring House, PA, USA.
authors.forename: Kaiyin
authors.initials: K
authors.lastname: Fei
authors.affiliation: Biostatistics, Merck, Rahway, NJ, USA.
authors.forename: Ruji
authors.initials: R
authors.lastname: Yao
authors.affiliation: MSD Medical Affairs, Luzern, Switzerland.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Khalifa
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D002097:C-Reactive Protein; C529000:golimumab
keywords: Indians; efficacy; golimumab; rheumatoid arthritis; safety