ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1598

Olokizumab Treatment of Both Western and Asian Patients with Rheumatoid Arthritis Who Have Failed Anti-TNF Treatment Results in Sustained Improvements in Patient-Reported Outcomes

Mark C. Genovese1, Patrick Durez2, Roy Fleischmann3, Yoshiya Tanaka4, Daniel E. Furst5, Hisashi Yamanaka6, Igor Vasyutin7, Thangavel Kaviarasu8, Elena Korneva7, Dmitry Koloda7 and Tsutomu Takeuchi9, 1Stanford University Medical Center, Palo Alto, CA, 2Department of Rheumatology, Université Catholique de Louvain, Brussels, Belgium, 3Medicine, University of Texas Southwestern Medical Center, Dallas, TX, 4The First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 5David Geffen School of Medicine at UCLA, Los Angeles, CA, 6Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 7R-Pharm CJSC, Moscow, Russian Federation, 8Quintiles Inc, Mumbai, India, 9School of Medicine, Keio University, Tokyo, Japan

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Monday, November 14, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Rheumatoid arthritis (RA) has a high patient (pt) burden with significant impact on health-related quality of life. We report the effect of treatment with olokizumab (OKZ), an interleukin-6 (IL-6)-targeting monoclonal antibody, on pt-reported outcomes (PROs) in both Western and Asian pts with moderate to severe RA who have previously failed anti-TNF therapy.

Methods: Data are reported from two multicenter, double-blind RCTs, RA0056 (NCT01242488) and RA0083 (NCT01463059), and their corresponding open-label extension (OLE) studies, RA0057 (NCT01296711) and RA0089 (NCT01533714). In the RCTs, pts with RA receiving MTX who had previously failed anti-TNF therapy were recruited from Belgium, the US and the UK (RA0056),1 and Japan, Korea and Taiwan (RA0083).2 Pts received placebo (PBO), subcutaneous (sc) OKZ 60/120/240 mg every 2 weeks (wks; Q2W) or 4 wks (Q4W) (240 mg Q2W in RA0056 only), or (in RA0056 only) intravenous tocilizumab (TCZ) 8 mg/kg Q4W. Completers were eligible for the OLEs, in which all pts received sc OKZ 120 mg Q2W + MTX (RA0057: 12.5–25.0 mg/wk with dose reductions permitted after Wk 12; RA0089: 6.0–16.0 mg/wk in Japan, 7.5–20.0 mg/wk in Korea and Taiwan). Pts with ongoing serious adverse events were excluded from the OLEs. Clinical efficacy and safety data have been reported previously.1,2 PROs assessed included health assessment questionnaire-disability index (HAQ-DI), pt’s global assessment of disease activity (PtGADA), pt’s assessment of arthritis pain (PtAAP), Bristol Rheumatoid Arthritis Fatigue-Multi-Dimensional Questionnaire (BRAF-MDQ) and EuroQol 5-Dimensions Questionnaire (EQ-5D). Data are reported for the OL full analysis set (all pts who received ≥1 dose of OKZ with ≥1 efficacy measurement in the OLE). Observed data are reported for Wk 12 of the RCTs and the last time point at which ≥50% of pts reported data in the OLEs; Wk 48 in RA0057 and Wk 40 in RA0089.

Results: 198 pts completed RA0056; 190 (114 OKZ, 40 PBO, 36 TCZ) enrolled in RA0057. 105 pts completed RA0083; 103 (79 OKZ, 24 PBO) enrolled in RA0089. At Wk 12 of the RCTs, both Western (Table A) and Asian (Table B) OKZ-treated pts reported greater improvements in PROs compared to PBO-treated pts, similar to TCZ pts. As expected, PBO-treated pts reported rapid improvements in PROs following switch to OKZ. These changes were maintained to Wk 40/48 of the OLE both in pts receiving OKZ throughout (OKZ→OKZ) and in TCZ-pts switching to OKZ at OLE entry (TCZ→OKZ). Improvements were comparable in magnitude in Western and Asian patients.

Conclusion: OKZ treatment of both Western and Asian pts with moderate to severe RA resulted in sustained improvements across a range of PROs, both in the RCT and OLE, with similar levels of improvement seen in both populations. Changes were maintained to the last time point examined: Wk 40 in Asian pts and Wk 48 in Western pts. References: 1. Genovese M. Ann Rheum Dis 2014;73(9):1607–15; 2. Takeuchi T. Mod Rheum 2016;26(1):15–23

Disclosure: M. C. Genovese, UCB Pharma, R-Pharm CJSC, Sanofi-Aventis, Roche, 2,UCB Pharma, R-Pharm CJSC, Sanofi-Aventis, Roche, GlaxoSmithKline, BirdRock Bio, 5; P. Durez, None; R. Fleischmann, Genentech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Eli Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca, Janssen, 2,Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Eli Lilly, Sanofi-Aventis, Novartis, AstraZeneca, Janssen, 5; Y. Tanaka, Bristol-Myers Squibb, MSD, Chugai, Mitsubishi- Tanabe, Astellas, AbbVie, Daiichi-Sankyo, 2,Mitsubishi-Tanabe, Abbott, AbbVie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GlaxoSmithKline, AstraZeneca, UCB Pharma, 5; D. E. Furst, Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, and UCB Pharma, 2,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen IDEC, Janssen, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, and UCB Pharma, 5,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen, IDEC, Janssen, Gilead, NIH, Roche/Genentech, and UCB Pharma, 9; H. Yamanaka, Teijin Pharma, Chugai, Astellas, Bristol-Myers Squibb, AbbVie, Daiichi-Sankyo, Mitsubishi-Tanabe, Takeda, UCB Pharma, 2,Teijin Pharma, Bristol-Myers Squibb, AbbVie, 5; I. Vasyutin, R-Pharm CJSC, 3; T. Kaviarasu, Quintiles Inc, 3; E. Korneva, Employee of R-Pharm CJSC, 3; D. Koloda, R-Pharm CJSC, 3; T. Takeuchi, AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe, Asahi Kasei, 5,Abott, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda, Teijin, 2.

To cite this abstract in AMA style:

Genovese MC, Durez P, Fleischmann R, Tanaka Y, Furst DE, Yamanaka H, Vasyutin I, Kaviarasu T, Korneva E, Koloda D, Takeuchi T. Olokizumab Treatment of Both Western and Asian Patients with Rheumatoid Arthritis Who Have Failed Anti-TNF Treatment Results in Sustained Improvements in Patient-Reported Outcomes [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/olokizumab-treatment-of-both-western-and-asian-patients-with-rheumatoid-arthritis-who-have-failed-anti-tnf-treatment-results-in-sustained-improvements-in-patient-reported-outcomes/. Accessed .

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