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SAT0148 Improvements in Patient-Reported Outcomes with Olokizumab Treatment in Patients with Active, Moderate To Severe Rheumatoid Arthritis Who Had Failed Previous Anti-TNF Therapy: Results from The Ra0056 Double-Blind, Randomized Controlled Study, and RA0057, Its Open-Label Extension
  1. M. Genovese1,
  2. R. Fleischmann2,
  3. D. Furst3,
  4. N. Janssen4,
  5. J. Carter5,
  6. B. Dasgupta6,
  7. C. Pitzalis7,
  8. I. Vasyutin8,
  9. T. Kaviarasu9,
  10. A. Krotkova8,
  11. P. Durez10
  1. 1Stanford University Medical Center, Stanford
  2. 2University of Texas Southwestern Medical Center, Dallas
  3. 3UCLA, Los Angeles
  4. 4Houston Institute for Clinical Research, Houston
  5. 5University of South Florida Health, Tampa, United States
  6. 6Southend University Hospital, Westcliff-on-Sea
  7. 7Queen Mary University of London, London, United Kingdom
  8. 8R-Pharm CJSC, Moscow, Russian Federation
  9. 9Quintiles Inc, Bangalore, India
  10. 10Université Catholique de Louvain, Brussels, Belgium


Background Rheumatoid arthritis (RA) has a high patient (pt) burden with significant impact on health-related quality of life. Here we report the effect of treatment with olokizumab (OKZ), an interleukin-6 (IL-6)-targeting monoclonal antibody in development for the treatment of RA, on pt-reported outcomes (PROs) in the phase 2 randomized controlled trial (RCT) RA0056 and its open-label extension (OLE) RA0057.

Objectives To assess the effect of OKZ treatment on PROs in pts with moderate to severe RA who have previously failed anti-TNF therapy.

Methods RA0056 was a dose-ranging, multicenter, double-blind RCT (NCT01242488) that enrolled pts with active, moderate to severe RA (meeting 1987 ACR classification criteria and/or ACR/EULAR diagnostic score ≥6; ≥6 swollen and ≥6 tender joints; CRP ≥1.2x upper limit of normal). Pts were receiving stable dose MTX 12.5–25mg/week (wk) for ≥6 wks and were intolerant to, or had a previous inadequate response to, ≥1 anti-TNF ≤2 years prior to screening. Pts received 1 of 9 treatments: subcutaneous (sc) placebo (PBO) every 4 weeks (Q4W) or every 2 weeks (Q2W), intravenous (iv) tocilizumab (TCZ) 8mg/kg Q4W, or sc OKZ 60/120/240mg Q2W or Q4W. Pts who completed the 12-wk study were eligible for entry into the RA0057 OLE (NCT01296711), in which all pts received sc OKZ 120mg Q2W+MTX. Pts with ongoing serious adverse events were excluded. PROs included change from baseline in: Health Assessment Questionnaire-Disability Index, Pt's Global Assessment of Disease Activity, Pt's Assessment of Arthritis Pain, Pt Acceptable Symptom State, Pt's Global Impression of Change, Bristol Rheumatoid Arthritis Fatigue-Multi-Dimensional Questionnaire and EuroQoL-5D Visual Analogue Scale. All missing data were left as missing.

Results 198 pts completed RA0056; 190 (114 OKZ, 40 PBO, 36 TCZ) enrolled in RA0057. At Wk12 of the RCT, OKZ-treated pts reported greater improvements in PROs compared to PBO pts, similar to TCZ pts (Table). These changes were maintained to Wk48 of the OLE both in pts receiving OKZ throughout (OKZ→OKZ) and in TCZ-pts switching to OKZ at OLE entry (TCZ→OKZ). PBO-pts reported improvements in PROs following switch to OKZ (PBO→OKZ).

Conclusions Treatment with OKZ resulted in improvements in PROs in patients with moderate to severe RA, which were maintained up to Wk48 of OLE.

Acknowledgement The authors acknowledge Costello Medical Consulting and ELM Group for writing and editorial assistance, funded by R-Pharm CJSC.

Disclosure of Interest M. Genovese Grant/research support from: UCB Pharma, R. Fleischmann Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Genentech Inc, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB Pharma;, Consultant for: Abbott, Amgen, AstraZeneca, BMS, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, D. Furst Grant/research support from: Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Consultant for: Abbott, Actelion, Amgen, BMS, BiogenIdec, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Speakers bureau: Abbott, Actelion, UCB Pharma, N. Janssen Grant/research support from: UCB Pharma, J. Carter Grant/research support from: Genetech Inc, Takeda, B. Dasgupta Grant/research support from: ACR, EULAR, HTA, RFPB, BHF, Napp, Fight for Sight, Roche, Merck, Sobi, Mundipharma, C. Pitzalis Grant/research support from: Abbott, AstraZeneca/MedImmune, Pfizer, Roche/Genentech, UCB Pharma, I. Vasyutin Employee of: R-Pharm CJSC, T. Kaviarasu Employee of: Quintiles Inc, A. Krotkova Employee of: R-Pharm CJSC, P. Durez: None declared

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