Comprehensive Disease Remission Achieved By Certolizumab Pegol Treatment, and Factors Associated With Certolizumab Pegol Comprehensive Disease Remission, In Rheumatoid Arthritis Patients With Predominantly High Disease Activity

Yoshiya Tanaka¹, Kazuhiko Yamamoto², Tsutomu Takeuchi³, Hisashi Yamanaka⁴, Naoki Ishiguro⁵, Katsumi Eguchi⁶, Akira Watanabe⁷, Hideki Origasa⁸, Tadao Okamoto⁹, Yumiko Wada⁹, Toshiharu Shoji⁹, Nobuyuki Miyasaka¹⁰ and Takao Koike¹¹, ¹The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ²Department of Allergy and Rheumatology, The University of Tokyo, Tokyo, Japan, ³Keio University, Tokyo, Japan, ⁴Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ⁵Department of Orthopedic Surgery, Nagoya University, Nagoya, Japan, ⁶Sasebo City General Hospital, Sasebo, Japan, ⁷Tohoku University, Sendai, Japan, ⁸Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan, ⁹UCB Pharma, Tokyo, Japan, ¹⁰Department of Medicine and Rheumatology, Graduate School of Medicine and Dentistry, Tokyo Medical and Dental University, Tokyo, Japan, ¹¹NTT Sapporo Medical Center, Sapporo, Japan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ACR, anti-TNF therapy, certolizumab pegol and rheumatoid arthritis (RA), Japanese

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy III

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The therapeutic goals of treating rheumatoid arthritis (RA) are clinical, structural and functional remissions.^1,2 Simultaneously achieving all three has been referred to as comprehensive disease remission (CDR). Certolizumab pegol (CZP) has demonstrated rapid and sustained improvement in disease activity and inhibition of structural damage in 2 double-blind (DB) trials, J-RAPID³ (with MTX; NCT00791999) and HIKARI⁴ (without MTX; NCT00791921), and in subsequent open-label extensions (OLE; NCT00851318 and NCT00850343, respectively) in Japanese patients (pts). This post-hoc analysis evaluated CDR achievement in RA pts with high baseline disease activity treated with CZP. Factors associated with CZP CDR at OLE Wk52 were also investigated.

Methods:

CDR was defined as simultaneous achievement of DAS28(ESR) ≤2.6 (DAS remission), HAQ-DI ≤0.5 (HAQ remission) and yearly change in (Δ) mTSS ≤0.5 (radiographic non-progression), while comprehensive disease control (CDC) was defined by substituting DAS28(ESR) <3.2 in CDR. CDC/CDR of CZP vs placebo (PBO), with and without MTX, were evaluated at Wk24 of DB trials on the full analysis set (FAS) population of CZP (200mg every 2 weeks [Q2W]; approved dose) and PBO groups in J-RAPID (CZP n=82, PBO n=77) and HIKARI (CZP n=116, PBO n=114). Additionally, CZP CDC/CDR were evaluated at OLE entry and Wk52 for DB CZP 200mg Q2W pts who entered OLE studies (J-RAPID n=74, HIKARI n=105; FAS). Factors associated with CZP CDC/CDR at OLE Wk52 were analyzed for all DB CZP pts, regardless of dose, who entered OLE (J-RAPID n=215, HIKARI n=105; FAS), using several Wk12 clinical response measures eg. DAS28(ESR) disease activity and HAQ.

Results :

CDC and CDR at Wk24 of J-RAPID were 28.0% and 13.4% for CZP, and 5.2% and 0% fo PBO, respectively (Table). In HIKARI, 25.0% and 15.5% CZP pts achieved CDC and CDR at Wk24 vs 0% and 0% PBO pts, respectively. In HIKARI, CZP was shown to be similarly effective in attaining CDR as monotherapy (9/54, 16.7%) or with concomitant non-MTX DMARDs (9/62, 14.5%). CDC and CDR at OLE Wk52 were 37.8% and 24.3% in J-RAPID, and 28.6% and 21.9% in HIKARI, respectively (Table). Of pts with DAS remission at Wk12, 50% (14/28) and 50% (8/16) achieved CDR at OLE Wk52 in J-RAPID and HIKARI, respectively. Similarly, 35% (J-RAPID 43/124) and 31% (HIKARI 19/62) of pts with Wk12 HAQ remission achieved CDR at OLE Wk52.

Conclusion :

CZP treatment demonstrated high rates of CDC/CDR at Wk24 and OLE Wk52 in RA pts with high baseline disease activity. CZP treatment, regardless of concomitant MTX or as monotherapy, was effective in achieving CDC/CDR. Wk12 DAS or HAQ remission with CZP was associated with high achievement of CDR at OLE Wk52.

References:

1. Smolen J.S. Ann Rheum Dis 2010;69(6):964-975; 2. Singh J. Arthritis Care Res 2012;64(5):625-639; 3. Yamamoto K. Arthritis Rheum 2011;63(Supp10):S474; 4. Yamamoto K. Arthritis Rheum 2011;63(Supp10):S476

Disclosure:

Y. Tanaka,

BMS, MSD, Chugai, Mitsubishi-Tanabe, Astellas, Abbvie, Daiichi-Sankyo,

UCB, Mitsubishi-Tanabe, Abbott, Abbvie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Eli Lilly, Quintiles, MSD, Asahi Kasei,

K. Yamamoto,

UCB Pharma, Pfizer, Abbott, BMS, Roche, Chugai, Mitsubishi-Tanabe and Eisai,

UCB Pharma, Pfizer, Abbott, Santen, Mitsubishi-Tanabe and Eisai,

T. Takeuchi,

AstraZeneca, Eli Lilly, Novartis, Mitsubishi-Tanabe and Asahi Kasei,

Abott, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Nippon Shinyaku, Otsuka, Pfizer, Sanofi-Aventis, Santen, Takeda and Teijin,

UCB Pharma, Abbott, BMS, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer and Takeda,

H. Yamanaka,

UCB Pharma, Abbott, Astellas, BMS, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer and Takeda,

N. Ishiguro,

Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, BMS, Eisai, Janssen, Kaken and Pfizer,

Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, BMS, Eisai, Janssen, Kaken, Pfizer, Taisho-Toyama and Otsuka,

K. Eguchi,

UCB Pharma.,

A. Watanabe,

Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical and Meiji Seika,

MSD, GSK, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe, Pfizer,

H. Origasa,

UCB Pharma and Astellas,

T. Okamoto,

UCB Pharma,

Y. Wada,

UCB Pharma,

T. Shoji,

UCB Pharma,

N. Miyasaka,

Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai and Astellas,

T. Koike,

UCB Pharma, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, BMS, Teijin and Daiichi-Sankyo,

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