FRI0112 INCREASED RISK OF SEVERE INFECTION RECURRENCE IN PATIENTS WHO DEVELOPED SEVERE INFECTIONS DURING BDMARDS THERAPY: A STUDY OF THE MIRAI COHORT

Background: One of the most important complications of biological disease-modifying antirheumatic drugs (bDMARDs) is severe infection, and management of patients who develop severe infection during treatment with bDMARDs is a great concern. However, no consensus exists regarding bDMARDs readministration following treatment for bDMARDs-associated infection. Objectives: We elucidated risk factors associated with severe infection recurrence in patients who developed severe infections during bDMARDs therapy. Severe infection was defined as an infection requiring hospitalization. Moreover, we analyzed whether bDMARDs readministration after severe infection in patients with rheumatoid arthritis (RA) was a risk for severe infection recurrence. Methods: The study sample comprised patients with RA who were examined and prescribed bDMARDs at Osaka Minami Medical Center between January 2010 and December 2017, as part of the MiRAi cohort. The patients who developed severe infections during bDMARDs treatment were followed-up for 12 months. Logistic regression analysis was performed using baseline disease activity, baseline treatment, and disease activity and treatment during the 12-month period. Results: Severe infections developed in 164 of a total of 1192 patients who were treated with bDMARDs during the study period, and the severe infection rate was 5.73/100 patients-years. Among the 164 patients, bDMARDs were readministered in 130 (79.3%), whereas treatment with bDMARDs was discontinued in 34 patients (20.7%). We observed 31 cases of patients with severe infections during the follow-up period (18.9/100 patients-years), of which 20 patients (15.4/100 patients-years) belonged to the bDMARDs readministration group and 11 (32.4/100 patients-years) belonged to the bDMARDs discontinuation group. The adjusted odds ratio (OR) for severe infection recurrence within 12 months in the bDMARDs readministration group was 0.39 [95% confidence interval (CI) 0.16–0.96]. At 12 months after infection, high-dose prednisolone treatment (adjusted OR 1.35, 95%CI 1.08–1.69), high C-reactive protein level (adjusted OR 1.28, 95%CI 1.02–1.62), and low serum albumin levels (adjusted OR 0.30, 95%CI 0.01–0.89) were associated with high risk of severe infection recurrence (Figure). Conclusion: Patients who developed severe infection during bDMARDs treatment were at an extremely high risk for severe infection irrespective of the readministration or discontinuation of bDMARDs after infection. Discontinuation of bDMARDs, high dose of prednisolone 12 months after infection, high levels of C-reactive protein 12 months after infection, and low levels of albumin 12 months after infection were identified as risk factors for severe infection recurrence in these patients. However, bDMARDs readministration did not increase the risk of severe infection recurrence. Reference: [1] Ramiro et al, Ann Rheum Dis 2017;76:1093-1101. Disclosure of Interests: Eri Oguro: None declared, Yuji Yoshida: None declared, Kentaro Kuzuya: None declared, Yasutaka Okita: None declared, Hidetoshi Matsuoka: None declared, Satoru Teshigawara: None declared, Maiko Yoshimura: None declared, Kentaro Isoda: None declared, Yoshinori Harada: None declared, Shiro Ohshima Grant/research support from: AbbVie, Eisai, Asahikasei, Speakers bureau: AbbVie, Eisai, Bristol-Meyers, Novartis, Astellas, Nippon-Kayaku, Pfizer, UCB, Ayumi, Daiichi-Sankyo, Takeda, Tanabe-Matsubishi, Chugai, Jun Hashimoto: None declared, Yukihiko Saeki: None declared