0243: Real World Evidence of Treatment Effectiveness and Unfavorable Clinical Events for Elderly-onset Early Rheumatoid Arthritis in Japan: Results from the IORRA Study

Naohiro Sugitani¹, Eiichi Tanaka¹, Eisuke Inoue², Kotaro Watanabe³, Mai Abe³, Eri Sugano³, Kumiko Saka³, Moeko Ochiai³, Rei Yamaguchi³, Katsunori Ikari⁴ and Masayoshi Harigai¹, ¹Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan, ²Research Administration Center, Showa University, Shinagawa-ku, Japan, ³Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine, Shinjuku-ku, Japan, ⁴Department of Orthopedic Surgery, Tokyo Women’s Medial University School of Medicine, Shinjuku, Japan

Background/Purpose: The number of elderly patients with rheumatoid arthritis (RA) has been constantly increasing. As of December 2021, 50.3% of the patients with RA who participated in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort were 65 years or older. In patients with elderly-onset RA, the decline in activities of daily living (ADL) due to RA has significant impact on their vital prognosis. Early control of disease activity of RA can contribute to maintenance of ADL and prevention of the RA progression. However, special consideration should be given to management of RA in the elderly patients because of the increased frequency of comorbidities and adverse events. The actual status and sequelae of medical treatment for patients with elderly-onset early RA have not been clarified in the real world. In this study, we longitudinally investigated the outcomes of treatment and unfavorable clinical events in patients with elderly-onset early RA in a clinical setting.

Methods: Among the patients with RA enrolled in the IORRA from 2000 to 2016, the patients with early RA (disease duration of RA within 2 years) who were aged ≥65 years (≥65 years group) and those who were < 65 years (< 65 years group) were enrolled in this study. The primary endpoint was changes in the Disease Activity Score in 28 joints (DAS28) and Japanese version of Health Assessment Questionnaire (J-HAQ) for 5 years. The secondary endpoint was incidence rates of pre-specified adverse events (death, major adverse cardiovascular event [MACE], malignancy, hospitalization due to infection, herpes zoster, and fracture) up to 5 years. Association of the age group with each event was assessed using Cox regression analysis stratified by the year of enrollment.

Results: There were 813 patients in the ≥65 years group (mean age 72.0 years, female 72.0%, mean disease duration of RA 0.78 years, DAS28 3.88, J-HAQ 0.82, RF-positive 68.1%, ACPA-positive 64.5%) and 2,457 patients in < 65 years group (mean age 48.3 years, female 83.7%, RA disease duration 0.77 years, DAS28 3.67, J-HAQ 0.58, RF-positive 75.4%, ACPA-positive 79.1%). The proportions of patients using methotrexate and biological disease modifying antirheumatic drugs were 70.6% and 8.4% in the ≥65 years group, respectively, and 81.6% and 19.4% in < 65 years group, respectively, during the observation period. Mean DAS28 and J-HAQ improved promptly after 1 year of enrollment in both groups. Mean DAS28 and J-HAQ in the < 65 years group were < 2.6 and < 0.5, respectively, on and after Year 2, but in ≥65 years group, mean DAS28 remained >2.6 and mean J-HAQ deteriorated after Year 2 (Figure 1). The incidence rates of death, MACE, malignancy, hospitalization due to infection, herpes zoster and fracture were significantly higher in the ≥65 years group compared to < 65 years group (Table 1).

Conclusion: Our study indicated that patients with elderly-onset early RA could achieve LDA although it was difficult for these patients to achieve clinical remission and maintain long-term functional remission. In addition, patients with elderly-onset early RA have a higher risk for unfavorable clinical events than those with younger-onset early RA.

Figure 1. Comparison of the changes in the Disease Activity Score in 28 joints (DAS28) and Japanese version of Health Assessment Questionnaire (J-HAQ) in ≥65 years group and < 65 years group for 5 years

Table 1. Incidence and the hazard ratio of each unfavorable clinical event in the ≥65 years group compared with < 65 years group for 5 years
Disclosures: N. Sugitani, None; E. Tanaka, Bristol-Myers Squibb(BMS), Eli Lilly, GlaxoSmithKlein(GSK), Boehringer-Ingelheim, Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo, Inc., Eisai Co., Ltd., Gilead Sciences, Inc., Kyowa Pharma Chemical CO., Ltd., Mitsubishi Tanabe Pharma Co., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Teijin Pharma Ltd., Takeda Pharmaceutical Co. , Ltd., UCB Japan Co. Ltd., Viatris Japan, AbbVie Japan GK, Pfizer Japan Inc., Janssen Pharmaceutical K.K.; E. Inoue, Bristol-Myers Squibb(BMS), Nippontect systems; K. Watanabe, None; M. Abe, None; E. Sugano, None; K. Saka, None; M. Ochiai, None; R. Yamaguchi, None; K. Ikari, AbbVie/Abbott, Bristol-Myers Squibb(BMS), Eli Lilly, Astellas Pharma Inc., Asahi Kasei Corp., Ayumi Pharmaceutical Co., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen, Kaken Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer, Takeda Pharmaceutical Co. Ltd., Teijin Pharma Ltd., UCB; 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.