ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1435

Consistent Inhibition of Joint Destruction By Denosumab in Important Subgroups of Japanese Patients with Rheumatoid Arthritis: Pooled Analysis of Phase 2 and 3 Studies

Yoshiya Tanaka1, Tsutomu Takeuchi2, Satoshi Soen3, Naoki Ishiguro4, Hisashi Yamanaka5, Toshiyuki Yoneda6, Sakae Tanaka7, Takaya Nitta8, Naoki Okubo9, Harry K. Genant10 and Désirée van der Heijde11, 1University of Occupational and Environmental Health, Kitakyushu, Japan, 2Keio University School of Medicine, Tokyo, Japan, 3Kindai University Nara Hospital, Ikoma, Japan, 4Orthopaedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan, 5Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 6Indiana University School of Medicine, Indianapolis, IN, 7Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, Bunkyo-ku, Japan, 8Daiichi Sankyo Co., Ltd., Tokyo, Japan, 9DaiichiSankyo CO., LTD., Tokyo, Japan, 10University of California, San Francisco, CA, 11Leiden University Medical Center, Leiden, Netherlands

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Monday, November 6, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports

Session Type: ACR Poster Session B

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

Background/Purpose:

Denosumab is a fully human monoclonal antibody (IgG2 subclass) that inhibits bone resorption by blocking RANKL. Phase 2 (DRIVE) and phase 3 (DESIRABLE) studies demonstrated that denosumab inhibited progression of joint destruction in Japanese patients with rheumatoid arthritis (RA). The results of subgroup analyses of DRIVE study have already been reported in ACR 2014. The subgroup analyses of DRIVE and DESIRABLE studies were undertaken to understand whether denosumab was broadly effective upon progression of the joint destruction in RA patients.

Methods:

These analyses used pooled data from two randomized, multicenter, double-blind placebo control trials in RA patients treated with denosumab [60 mg every 6 months (Q6M) or 60 mg every 3 months (Q3M)] or placebo. All patients continued conventional synthetic DMARDs (including MTX) and a supplement of calcium and vitamin D throughout the study. The modified total Sharp score (mTSS), the bone erosion score (ES) and the joint space narrowing score (JSN) were assessed by the modified Sharp van der Heijde method. Subgroup analyses were conducted according to risk factors for radiographic damage.

Results:

A total of 909 patients were included (306 in placebo, 302 in Q6M and 301 in Q3M). Denosumab significantly inhibited the progression of mTSS and ES from baseline to 12 months compared to placebo, whereas denosumab didnft have an effect on JSN. The incidence of adverse events (AEs), serious AEs and AEs leading to discontinuation of study drug were similar among treatment groups. Each subgroup with a specific risk factor for radiographic damage showed consistent results for the mTSS in total group.

The same tendency was observed in ES.

Conclusion:

Denosumab inhibited the progression of the joint destruction at 12 months in Japanese patients with RA in subgroup analyses based on pooled data of DRIVE and DESIRABLE studies. These results indicate that denosumab broadly inhibits the progression of joint destruction in RA patients with risk factors for radiographic damage.

Disclosure: Y. Tanaka, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Bristol-Myers, Chugai Pharmaceutical, Astellas Pharma, Abbvie, MSD, DaiichiSankyo, Pfizer, Kyowa-Kirin, Eisai, Ono Pharmaceutical, 2,DaiichiSankyo, Astellas Pharma, Pfizer, Mitsubishi Tanabe Pharma, Bristol-Myers, Chugai Pharmaceutical, YL Biologics, Eli Lilly, Sanofi, Janssen, UCB, 8; T. Takeuchi, Astellas Pharma, Bristol–Myers, Chugai Pharmaceutical, DaiichiSankyo, Takeda Pharmaceutical, Teijin Pharma, AbbVie, Asahikasei Pharma, Mitsubishi Tanabe Pharma, Pfizer Japan, Taisho Toyama Pharma, Eisai, AYUMI Pharmaceutical, 2,Astra Zeneca, Eli Lilly Japan, Novartis Pharma, Mitsubishi Tanabe Pharma, AbbVie, Nipponkayaku, Janssen Pharmaceutical, Astellas Pharma, Taiho Pharmaceutical, 5,AbbVie, Bristol–Myers, Chugai Pharmaceutical, Mitsubishi Tanabe Pharma, Pfizer Japan, and Astellas Pharma, DiaichiSankyo, 8; S. Soen, Eisai, DiaichiSankyo, Takeda Pharmaceutical, 2,Asahikasei Pharma, Astellas Pharma, Eisai, MSD, Ono Pharmaceutical, DiaichiSankyo, Takeda Pharmaceutical, Chugai Pharmaceutical, Teijin Pharma, Pfizer Japan, 8; N. Ishiguro, Abbott, Astellas Pharma, Bristol-Myers, Chugai Pharmaceutical, DaiichiSankyo, Eisai, Hisamitsu, Janssen Pharmaceutical, Kaken Pharmaceutical, Mitsubishi Tanabe Pharma, Otsuka Pharmaceutical, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical, UCB, 2,Abbott, Astellas Pharma, Bristol-Myers, Chugai Pharmaceutical, DaiichiSankyo, Eisai, Hisamitsu, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Otsuka Pharmaceutical, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical, UCB, 8; H. Yamanaka, MSD, Astellas Pharma, AbbVie, BMS, Kaken Pharmaceutical, UCB, Ono, Ayumi Pharmaceutical, Eisai, DaiichiSankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Chugai Pharmaceutical, Teijin Pharma, Torii, Nipponshinyaku, Pfizer, 2,Pfizer, YL biologics, Takeda Pharmaceutical, Teijin, BMS, Nipponkayaku, Chugai Pharmaceutical, Mitsubishi Tanabe Pharma, DaiichiSankyo, Astellas Pharma, 5; T. Yoneda, Indiana University, 3,DaiichiSankyo, 5; S. Tanaka, Amgen, Astellas Pharma, BioPharma, DaiichiSankyo, Teijin Pharma, Asahi Kasei Pharma, Ono Pharmaceutical, Eli Lilly, Pfizer, MSD, Astellas Pharma, AbbVie, Eisai, Kaken Pharmaceutical, Johnson & Johnson, Taisho Toyama Pharmaceutical, Mitsubishi Tanabe Pharm, 5,The Japanese Orthopaedic Association Corporation, Director, the Japanese Society for Bone and Mineral Research, Chief Director, Japan College of Rheumatology, Director, 6; T. Nitta, DaiichiSanyo, 3; N. Okubo, DaiichiSanyo, 3; H. K. Genant, DaiichiSanyo, Pfizer, Amgen, Bioclinica, Eli-Lilly, Janssen, Servier, Novartis Pharmaceutical, Takeda Pharmaceutical, Merck, Biomarin, Clemencia, Agnovos, Regeneron, 5; D. van der Heijde, Imaging Rheumatology bv., 3,AbbVie, Amgen, Astellas Pharma, AstraZeneca, BMS, Boeringer Ingelheim, Celgene, DaiichiSankyo, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis Pharmaceuticals, Pfizer, Regeneron, Roche Pharmaceutical, Sanofi, UCB, 5.

To cite this abstract in AMA style:

Tanaka Y, Takeuchi T, Soen S, Ishiguro N, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Consistent Inhibition of Joint Destruction By Denosumab in Important Subgroups of Japanese Patients with Rheumatoid Arthritis: Pooled Analysis of Phase 2 and 3 Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/consistent-inhibition-of-joint-destruction-by-denosumab-in-important-subgroups-of-japanese-patients-with-rheumatoid-arthritis-pooled-analysis-of-phase-2-and-3-studies/. Accessed .

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