PMID- 26050104
OWN - NLM
STAT- MEDLINE
DCOM- 20170116
LR  - 20181113
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Linking)
VI  - 35
IP  - 4
DP  - 2016 Apr
TI  - Itolizumab in combination with methotrexate modulates active rheumatoid 
      arthritis: safety and efficacy from a phase 2, randomized, open-label, 
      parallel-group, dose-ranging study.
PG  - 1059-64
LID - 10.1007/s10067-015-2988-9 [doi]
AB  - The objective of this study was to assess the safety and efficacy of itolizumab 
      with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate 
      response to methotrexate. In this open-label, phase 2 study, 70 patients 
      fulfilling American College of Rheumatology (ACR) criteria and negative for 
      latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8 mg/kg 
      itolizumab weekly combined with oral methotrexate, and methotrexate alone 
      (2:2:2:1). Patients were treated for 12 weeks, followed by 12 weeks of 
      methotrexate alone during follow-up. Twelve weeks of itolizumab therapy was well 
      tolerated. Forty-four patients reported adverse events (AEs); except for six 
      severe AEs, all others were mild or moderate. Infusion-related reactions mainly 
      occurred after the first infusion, and none were reported after the 11th 
      infusion. No serum anti-itolizumab antibodies were detected. In the full analysis 
      set, all itolizumab doses showed evidence of efficacy. At 12 weeks, 50 % of the 
      patients achieved ACR20, and 58.3 % moderate or good 28-joint count Disease 
      Activity Score (DAS-28) response; at week 24, these responses were seen in 22 and 
      31 patients. Significant improvements were seen in Short Form-36 Health Survey 
      and Health Assessment Questionnaire Disability Index scores. Overall, itolizumab 
      in combination with methotrexate was well tolerated and efficacious in RA for 
      12 weeks, with efficacy persisting for the entire 24-week evaluation period. 
      (Clinical Trial Registry of India, http://ctri.nic.in/Clinicaltrials/login.php , 
      CTRI/2008/091/000295).
FAU - Chopra, Arvind
AU  - Chopra A
AD  - Department of Rheumatology, Center for Rheumatic Disease, Pune, India.
FAU - Chandrashekara, S
AU  - Chandrashekara S
AD  - ChanRe Rheumatology and Immunology Centre and Research, Bangalore, India.
FAU - Iyer, Rajgopalan
AU  - Iyer R
AD  - Department of Orthopedics, St. John's Medical College Hospital, Bangalore, India.
FAU - Rajasekhar, Liza
AU  - Rajasekhar L
AD  - Department of Rheumatology, Nizams institute of Medical sciences, Hyderabad, 
      India.
FAU - Shetty, Naresh
AU  - Shetty N
AD  - Department of Orthopedics, M.S. Ramaiah Memorial Hospital, Bangalore, India.
FAU - Veeravalli, Sarathchandra Mouli
AU  - Veeravalli SM
AD  - Department of Rheumatology, Krishna Institute of Medical Sciences, Secunderabad, 
      India.
FAU - Ghosh, Alakendu
AU  - Ghosh A
AD  - Department of Rheumatology, Institute of Post Graduate Medical Education and 
      Research, Kolkata, India.
FAU - Merchant, Mrugank
AU  - Merchant M
AD  - Department of Orthopedics, Shubhechha Multispecialty Hospital, Vadodara, India.
FAU - Oak, Jyotsna
AU  - Oak J
AD  - Department of Rheumatology, LTM Medical College & LTMG Hospital, Mumbai, India.
FAU - Londhey, Vikram
AU  - Londhey V
AD  - Medicine Department and Rheumatology Clinic, TNMC & BYL Nair Charitable Hospital, 
      Mumbai, India.
FAU - Barve, Abhijit
AU  - Barve A
AD  - Research & Development, Biocon Research Limited, Bommasandra Industrial Estate - 
      phase IV, Bangalore, 560099, India. abhijit.barve@biocon.com.
FAU - Ramakrishnan, M S
AU  - Ramakrishnan MS
AD  - Research & Development, Biocon Research Limited, Bommasandra Industrial Estate - 
      phase IV, Bangalore, 560099, India.
FAU - Montero, Enrique
AU  - Montero E
AD  - Research & Development, Biocon Research Limited, Bommasandra Industrial Estate - 
      phase IV, Bangalore, 560099, India.
AD  - Center of Molecular Immunology, Havana, Cuba.
LA  - eng
SI  - CTRI/CTRI/2008/091/000295
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150607
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - XQQ2RHV14N (itolizumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - Humans
MH  - India
MH  - Male
MH  - Methotrexate/*administration & dosage
MH  - Middle Aged
MH  - Patient Safety
MH  - Reproducibility of Results
MH  - Rheumatology/methods
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
OTO - NOTNLM
OT  - ACR
OT  - CD6
OT  - DAS-28
OT  - Itolizumab
OT  - Methotrexate
OT  - Monoclonal antibody
EDAT- 2015/06/08 06:00
MHDA- 2017/01/17 06:00
CRDT- 2015/06/08 06:00
PHST- 2015/04/30 00:00 [received]
PHST- 2015/05/30 00:00 [accepted]
PHST- 2015/05/14 00:00 [revised]
PHST- 2015/06/08 06:00 [entrez]
PHST- 2015/06/08 06:00 [pubmed]
PHST- 2017/01/17 06:00 [medline]
AID - 10.1007/s10067-015-2988-9 [pii]
AID - 10.1007/s10067-015-2988-9 [doi]
PST - ppublish
SO  - Clin Rheumatol. 2016 Apr;35(4):1059-64. doi: 10.1007/s10067-015-2988-9. Epub 2015 
      Jun 7.