FRI0490 GOAL-DIRECTED TREATMENT OF OSTEOPOROSIS IN PATIENTS WITH RHEUMATOID ARTHRITIS USING DENOSUMAB FOR THREE YEARS
Authors: Yuji Hirano, Yasuhide Kanayama, Kyosuke Hattori, Daisuke Kihira, Naoki Ishiguro, Toshihisa Kojima
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Osteoporosis (OP) is frequently concomitant with rheumatoid arthritis (RA). Effective treatment have to be performed in OP in RA (RAOP). Denosumab (DMB) is one of the promising drugs for the treatment of RAOP. We reported results of 12-month DMB treatment for RAOP from Japanese multicenter registry study (TBCR-BONE) in EULAR2016 <sup>1)</sup>. Recently treatment goal of OP was reported from American society for bone and mineral research and National Osteoporosis Foundation (ASBMR-NOF) working group (Goal-Directed Treatment) <sup>2)</sup>. This progress report advocated that the goal of treatment is a T-score&gt;-2.5 at femoral neck, total hip (TH) or lumbar spine (LS) by DXA if the primary reason for starting treatment was T-score&gt;-2.5 at that skeletal site. The Working Group judged that it was intuitively reasonable to expect that initial treatment should offer at least a 50% chance of achieving the treatment goal within 3 to 5 years of starting therapy. <h3>Objectives</h3> The aim of this retrospective study is to evaluate whether 3-year DMB treatment can achieve treatment goal of OP reported recently from TBCR-BONE. <h3>Methods</h3> This study used 78 female RAOP patients who completed 3-year DMB treatment for RAOP. 36 patients in whom baseline T-score of LS-BMD were -2.5 or less were included in LS-BMD analysis. 52 patients in whom baseline T-score of TH-BMD were -2.5 or less were included in TH-BMD analysis in the same way. As was in clinical setting in Japan, 60mg DMB was administered every 6 months with vitamin D3 agent. Patients' characteristics, time course of T-score and baseline characteristics related to achievement of treatment goal (T-score&gt;-2.5) were investigated. <h3>Results</h3> Baseline characteristics of 78 patients: Mean age was 71 years. RA duration was 17 years. Prednisolone user was 32%. LS-BMD analysis (n=35) T-score was significantly increased (-3.5 at baseline, -3.0 at 1 year, -2.9 at 2 years, -2.8 at 3 years). The rates of patients who achieved treatment goal were 30.6% at 1 year, 38.9% at 2 years and 44.4% at 3 years (Fig1A). The achiever had significant lower baseline fracture risk by FRAX (20.1% vs. 33.9%: p=0.013), significant lower baseline mHAQ (0.45 vs. 1.05: p=0.03) and significant lower baseline T-score of LS-BMD (-3.0 vs. -3.9: p&lt;0.01) than the non-achiever did. TH-BMD analysis (n=52) T-score was significantly increased (-3.2 at baseline, -3.0 at 1 year, -2.9 at 2 years, -2.9 at 3 years). The rates of patients who achieved treatment goal were 19.2% at 1 year, 28.8% at 2 years and 25.0% at 3 years (Fig1B). The achiever had significant lower baseline bone turn over marker (P1NP and TRACP-5b) and significant lower baseline T-score of TH-BMD (-2.6 vs. -3.3: p&lt;0.01) than the non-achiever did. Cut-off values at baseline for achievement of treatment goal calculated using receiver operating characteristic analysis was -3.4 in LS-BMD and -2.7 in THBMD. <h3>Conclusion</h3> This study suggested that achievement of treatment goal in RAOP is not possible in LS-BMD and in TH-BMD when 3-year DMB was used as treatment for RAOP. Longer duration or earlier initiation of DMB treatment is necessary to achieve the goal. Although response in LS-BMD was related to fracture risk and physical function, response in TH-BMD was related to bone turnover. We will report 5-year results in the future. <h3>References</h3> [1] Hirano, et al. Ann Rheum Dis2016; 75 (Suppl2): 94 [2] Cummings, et al. J Bone Miner Res2017; 32: 3-10 <h3>Disclosure of Interests</h3> Yuji Hirano: None declared, Yasuhide Kanayama: None declared, Kyosuke Hattori: None declared, Daisuke Kihira: None declared, Naoki Ishiguro Grant/research support from: AbbVie, Asahi Kasei, Astellas, Chugai, Daiichi-Sankyo, Eisai, Kaken, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and Zimmer Biomet, Consultant for: Ono, Speakers bureau: Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Pfizer, and Taisho Toyama, Toshihisa Kojima Grant/research support from: Chugai Pharmaceutical (Investigator Initiated Study), Novartis, Nippon Kayaku, Eli Lilly, Eisai, Speakers bureau: Chugai Pharmaceutical, Takeda Pharmaceutical, Pfizer, Eli Lilly Japan, Bristol Myers Squibb, Ono Pharmaceutical, Daiichi Sankyo, Astelas, UCB, Janssen Pharmaceutical, Tanabe Mitsubishi,