OP0048 RISK OF FLARE AND DAMAGE ACCRUAL AFTER TAPERING GLUCOCORTICOIDS IN SEROLOGICALLY ACTIVE CLINICALLY QUIESCENT PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Authors: Y. Katsumata; E. Inoue; M. Harigai; R. Kandane‐Rathnayake; W. Louthrenoo; A. Hoi; V. Golder; C. Lau; J. Cho; A. Lateef; Y. H. Chen; S. Luo; Y. Jan Wu; L. Hamijoyo; Z. Li; S. Sockalingam; S. Navarra; L. Zamora; Y. Hao; Z. Zhang; M. Chan; S. Oon; K. Ng; J. Kikuchi; T. Takeuchi; F. Goldblatt; S. O’Neill; N. Tugnet; A. Law; S. Bae; Y. Tanaka; N. Ohkubo; S. Kumar; M. Nikpour; E. Morand
Year: 2023

Some studies demonstrated that withdrawal of low-dose glucocorticoids in clinically quiescent systemic lupus erythematosus (SLE) patients increased the risk of flare [1]. An international survey of 130 clinicians showed that persistent abnormal serology led to a reluctance to reduce or discontinue medications [2].To assess the risk of flare and damage accrual after tapering glucocorticoids in serologically active clinically quiescent (SACQ) patients with SLE. Association of other medications with flare in SACQ patients was also analyzed.We used data from the Asia Pacific Lupus Collaboration cohort, prospectively collected from SLE patients (ACR/SLICC criteria) observed for at least 2 visits between 2013 and 2020. Disease activity and medication details were captured at enrolment and at routine visits. SACQ was defined at any visit as the state with serological activity (increased anti-dsDNA or hypocomplementemia) but without clinical activity as measured by SLEDAI-2K. Patients treated with 0 to 7.5 mg/day of prednisolone at a SACQ visit were analyzed after stratification according to the initial dosages of prednisolone. Cox proportional hazard models were used to assess the time-dependent relationship between decreasing prednisolone in SACQ patients and disease flares captured with the SELENA flare index at each subsequent visit, as well as subsequent damage accrual (≥1-point increase in SLICC/ACR damage index [SDI]). Each patient was observed for up to 2 years or until each outcome event occurred.From a total of 4,106 patients, 1,850 patients with SACQ and 8,905 visits were analyzed: 742, 271, and 180 patients experienced overall flare, severe flare, and increase in SDI, respectively. Tapering prednisolone was not associated with subsequent overall or severe flare: Each unit decrease in prednisolone dosage (1 mg/day) resulted in adjusted HRs 1.02 (95%CI, 0.99–1.05) and 0.98 (95%CI, 0.96–1.00) for overall and severe flare, respectively, in the group with initial prednisolone dosages of 0–7.5 mg/day. However, among SACQ patients, antimalarial use was significantly associated with reduced overall and severe flare in the groups with initial prednisolone of 0–7.5 or 0–5 mg/day. In addition, immunosuppressive use was significantly associated with reduced severe flare but not overall flare in these groups. Decreasing the dosage of prednisolone was significantly negatively associated with damage accrual in the groups with initial prednisolone dosages of 0–7.5 mg/day (adjusted HR [95%CI], 0.97 [0.96–0.99]) and 5–7.5 mg/day (adjusted HR [95%CI], 0.96 [0.94–0.99]) but not 0–5 mg/day (adjusted HR [95%CI], 0.98 [0.95–1.01]).Table 1.Summary results of association between decreasing the prednisolone dosages and disease flares or damage accrual in SLE patients with SACQInitial prednisolone dosage (mg/day)Overall disease flareSevere disease flareIncrease in SDI0 ≤ prednisolone ≤7.51.02 (0.99–1.05),p= 0.270.98 (0.96–1.00),p= 0.110.97 (0.96–0.99),p< 0.010 ≤ prednisolone ≤51.02 (0.98–1.06),p= 0.410.98 (0.96–1.01),p= 0.280.98 (0.95–1.01),p= 0.145 < prednisolone ≤7.51.01 (0.96–1.06),p= 0.840.98 (0.92–1.03),p= 0.410.97 (0.96–0.99),p< 0.01* HRs (95% CIs) per unit decrease in prednisolone dosages (1 mg/day) were calculated using Cox proportional hazard models and adjusted by initial prednisolone dosage, antimalarial, immunosuppressive, disease duration, SLEDAI-2K, age at visit, gender, and ethnicity.Tapering prednisolone was not significantly associated with subsequent flare in SLE patients who were SACQ. Antimalarial and immunosuppressive use were associated with reduced risk of flares in SACQ patients. Tapering prednisolone was associated with reduced risk of damage accrual in SACQ patients treated with more than 5 mg/day of prednisolone. These findings suggest glucocorticoid tapering is safe and protective in SLE patients in SACQ.[1]Rheumatology (Oxford). 2021;60:5517[2]Lupus Sci Med. 2017;4:e000173We acknowledge the unrestricted project grants received from AstraZeneca, BMS, Eli Lilly, GSK, Janssen, Merck Serono, and UCB to support data collection and project management contributing to this work.Yasuhiro Katsumata Speakers bureau: GlaxoSmithKline K.K., AstraZeneca K.K., Sanofi K.K., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd.Asahi Kasei Pharma, Astellas Pharma Inc., Mitsubishi Tanabe Pharma Corporation, Eisuke Inoue Speakers bureau: Bristol-Myers Squibb K.K., Eisai Co., Ltd., Consultant of: Nippontect Systems co., Ltd., Masayoshi Harigai Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc.,Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Consultant of: AbbVie, Boehringer-ingelheim, Bristol Myers Squibb Co., Kissei Pharmaceutical Co.,Ltd. Teijin Pharma, Grant/research support from: AbbVie Japan GK, Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Daiichi-Sankyo, Inc.,Eisai Co., Ltd., Kissei.Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., Sekiui Medical, Shionogi & Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin.Pharma Ltd., Rangi Kandane-Rathnayake: None declared, Worawit Louthrenoo: None declared, Alberta Hoi Speakers bureau: UCB, Janssen, Sandoz, Eli Lilly, Consultant of: Abbvie, GSK, Grant/research support from: AstraZeneca, GSK, BMS, Janssen, Merck Serono, Vera Golder: None declared, C.S. Lau Speakers bureau: AstraZeneca UK Ltd., Consultant of: AstraZeneca Pharmaceuticals LP, Jiacai Cho: None declared, Aisha Lateef: None declared, Yi-Hsing Chen: None declared, Shue Fen Luo: None declared, Yeong-Jian Jan Wu: None declared, Laniyati Hamijoyo: None declared, Zhanguo Li Consultant of: Pfizer, Roche, Janssen, Abbott, AbbVie, Bristol Myers Squibb, MSD, Celgene, Eli Lilly, GSK, Novartis, UCB Pharma, Grant/research support from: Pfizer, Roche, Janssen, Abbott, AbbVie, Bristol Myers Squibb, MSD, Celgene, Eli Lilly, GSK, Novartis, UCB Pharma, Sargunan Sockalingam Consultant of: Pfizer, AstraZeneca, ZP Therapeutics, Grant/research support from: Pfizer, AstraZeneca, ZP Therapeutics, Sandra Navarra Consultant of: Biogen, Boehringer Ingelheim, Astra Zeneca, Grant/research support from: Jannsen, Novartis, Pfizer, Glaxo Smith Kline, Leonid Zamora: None declared, Yanjie Hao: None declared, Zhuoli Zhang: None declared, Madelynn Chan: None declared, Shereen Oon: None declared, Kristine Ng Consultant of: AbbVie, Jun Kikuchi: None declared, Tsutomu Takeuchi Consultant of: AbbVie, Chugai, Mitsubishi-Tanabe, Grant/research support from: AbbVie, Mitsubishi-Tanabe, Eli Lilly Japan, Fiona Goldblatt: None declared, Sean O’Neill: None declared, Nicola Tugnet: None declared, Annie Law: None declared, Sang-Cheol Bae: None declared, Yoshiya Tanaka Speakers bureau: Behringer-Ingelheim, Eli Lilly, Abbvie, Gilead, AstraZeneca, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Pfizer, Mitsubishi-Tanabe, GlaxoSmithKline, Grant/research support from: Asahi-Kasei, Abbvie, Chugai, Eisai, Takeda, Daiichi-Sankyo, Behringer-Ingelheim, Naoaki Ohkubo: None declared, Sunil Kumar: None declared, Mandana Nikpour Speakers bureau: Actelion, GSK, Janssen, Pfizer, UCB, Paid instructor for: UCB, Consultant of: Boehringer Ingelheim, Certa Therapeutics, Eli.Lilly, GSK, Janssen, Pfizer, UCB, Grant/research support from: Actelion, Astra Zeneca, BMS, GSK, Janssen, UCB, Eric F. Morand Speakers bureau: AstraZeneca, EMD Serono, Gilead, Consultant of: AstraZeneca, BristolMyersSquibb, Biogen, Eli Lilly, EMD Serono, Novartis, Grant/research support from: AbbVie, Amgen, AstraZeneca, BristolMyersSquibb, Biogen, Eli Lilly, EMD Serono, Genentech, GSK, Janssen, UCB.