Tokyo Medical and Dental University Bunkyo-ku,Tokyo, Japan
Manami Nomura1, Takahiko Sugihara2, Hiroyuki Baba1, Tatsuro Ishizaki3, Tadashi Hosoya1, Mari Kamiya1, Takumi Matsumoto2, Kanae Kubo4, Fumio Hirano5, Masayo Kojima6, Nobuyuki Miyasaka5, Shinsuke Yasuda5 and Masayoshi Harigai7, 1Tokyo Medical and Dental University (TMDU), Tokyo, Japan, 2Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan, 3Human Care Research Team, Tokyo Metropolitan Institute of Gerontology., Tokyo, Japan, 4Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan, 5Department of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan, 6Department of Frailty Research, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Nagoya, Japan, 7Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan
Background/Purpose: Elderly patients with rheumatoid arthritis (RA) tend to have a higher risk for drug-related adverse events (AEs) than younger patients, and the effectiveness and safety of the treat-to-target (T2T) approach for patients with elderly-onset RA (EORA) are unclear. We have conducted a prospective cohort study, and reported that the three-year achievement rates of simplified disease activity index (SDAI) remission and health assessment questionnaire disability index (HAQ-DI) ≤ 0.5 were significantly higher in EORA patients adhering to T2T than those not adhering to T2T (1). Furthermore, multivariable analysis showed chronic lung diseases (CLD) at baseline were associated with increased SDAI after implementation of T2T (2) and serious AEs (SAEs) within the first three years (1). In this study, we evaluated the five-year effectiveness and safety of the T2T strategy in patients with EORA and CLD at baseline.
Methods: Patients who were methotrexate (MTX)-naïve EORA and had moderate-to-high disease activity based on a 28-joint disease activity score using erythrocyte sedimentation rate were registered in the study from 2008 to 2015. Patients with poor prognostic factors started MTX, while tacrolimus was started in patients who had difficulty receiving MTX due to interstitial lung disease (ILD). Glucocorticoids (GCs) were started at the discretion of an attending physician. If patients did not achieve low disease activity at Week 24 or later, a tumor necrosis factor inhibitor (TNFi) was started. If the first TNFi was ineffective, it was switched to another biological disease-modifying antirheumatic drug (bDMARD). The primary outcomes were a proportion of patients achieving SDAI remission and HAQ-DI ≤0.5 at Year 5 by non-responder imputation (NRI). Secondary outcomes were a proportion of patients with drop-out and SAEs at Year 5. Drop-out was defined as lost-to-follow-up or deterioration of RA-associated extra-articular disease or other rheumatic disease requiring moderate to high dose GC. SAEs included adverse events requiring hospitalization and death.
Results: Among 197 patients with EORA, 47 patients had CLD (ILD, n=31; airway disease, n=12; emphysema, n=11; others, n=2) (Table 1). The proportion of MTX use at baseline was significantly lower in patients with CLD than those without, but there was no significant difference between the groups at Year 5. The proportion of bDMARDs use was higher in patients with CLD than those without at Year 5 (Table 1). There was no significant difference between the groups in SDAI remission and HAQ-DI ≤ 0.5 at Year 5 (Table 1). The drop-out rate at Year 5 was not significantly different between the two groups. The cumulative probability of SAEs was 73.6% and 36.6% in those with and without CLD, respectively (p < 0.001).
Conclusion: EORA patients with CLD at baseline had a higher probability of SAEs, but the long-term treatment outcomes were not different between the two groups. T2T is effective and tolerated even among high-risk patients with EORA and CLD.
References 1. Sugihara T, et al. Rheumatology (Oxford). 2021;60(9):4252-4261 2. Sugihara T, et al. EULAR 2022 (POS0522) Disclosures: M. Nomura, None; T. Sugihara, Chugai Pharmaceutical Co., Ltd, AsahiKASEI Co., Ltd., Daiichi Sankyo, Ono Pharmaceutical, Pfizer, Bristol-Myers Squibb(BMS), Eli Lilly, AbbVie/Abbott, Astellas Pharma Inc, Mitsubishi-Tanabe Pharma Co., Janssen; H. Baba, None; T. Ishizaki, None; T. Hosoya, None; M. Kamiya, None; T. Matsumoto, None; K. Kubo, AsahiKASEI Co., Ltd., Bristol-Myers Squibb(BMS), AbbVie/Abbott, Chugai Pharmaceutical Co., Ltd, Boehringer-Ingelheim, Astellas Pharma, Eisai, Daiichi-Sankyo,, Mitsubishi Tanabe Pharma, Nippon Shinyaku; F. Hirano, None; M. Kojima, AbbVie/Abbott, Astellas,, Ayumi Pharma, Chugai Pharmaceutical Co., Ltd, Eisai, Eli Lilly, Janssen, Ono Pharmaceutical, Pfizer, Tanabe-Mitsubishi, Takeda Pharmaceutical Co., Ltd.; N. Miyasaka, None; S. Yasuda, AbbVie/Abbott, AsahiKASEI Co., Ltd., Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical, Eisai, Tanabe-Mitsubishi Pharmaceutical, Ayumi pharmaceutical corporation, CSL Behring, Japan Blood Products Organization, ImmunoForge, UCB, Eli Lilly, GlaxoSmithKlein(GSK); M. Harigai, AbbVie Japan GK, Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb(BMS), Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo, Inc., Eisai Co., Ltd., Eli Lilly Japan K.K., Kaken Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Nippon Shinyaku Co., Ltd., Pfizer Japan Inc., Taisho Pharmaceutical Co., Ltd., Teijin Pharma Ltd., UCB Japan Co., Ltd., Viatris Japan.