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POS0028 (2021)
DEFINING THE PREVALENCE OF UNMET NEED IN SLE: DATA FROM A LARGE MULTINATIONAL LONGITUDINAL SLE COHORT
R. Kandane-Rathnayake1, W. Louthrenoo2, A. Hoi1, V. Golder1, Y. H. Chen3, S. F. Luo4, Y. J. Jan Wu5, A. Lateef6, J. Cho6, L. Hamijoyo7, C. S. Lau8, S. Navarra9, L. Zamora9, Z. LI10, Y. An10, S. Sockalingam11, Y. Katsumata12, M. Harigai12, Y. Hao13, Z. Zhang13, J. Kikuchi14, T. Takeuchi14, B. Basnayake15, F. Goldblatt16,17, M. Chan18, K. Ng19, S. C. Bae20, S. Oon21, S. O’neill22, K. Gibson22, S. Kumar23, N. Tugnet24, Y. Tanaka25, M. Nikpour26, E. F. Morand1, on behalf of The Asia Pacific Lupus Collaboration
1Monash University, School of Clinical Sciences at Monash Health, Clayton, Australia
2Chiang Mai University Hospital, Department of Internal Medicine, Faculty of Medicine, Chiang Mai, Thailand
3Taichung Veterans General Hospital, Division of Allergy, Immunology and Rheumatology, Taichung, Taiwan, Republic of China
4Chang Gung Memorial Hospital, Department of Rheumatology, Allergy and Immunology, Taipei, Taiwan, Republic of China
5Chang Gung Memorial Hospital, Department of Rheumatology, Allergy and Immunology, Keelung, Taiwan, Republic of China
6National University Hospital, Rheumatology Division, University Medical Cluster, Singapore, Singapore
7Padjadjaran University/ Hasan Sadikin General Hospital, Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Bandung, Indonesia
8The University of Hong Kong/Queen Mary Hospital, Division of Rheumatology & Clinical Immunology, Department of Medicine, Pok fu lam, Hong Kong (SAR)
9University of Santo Tomas Hospital, Joint and Bone Center, Manila, Philippines
10People’s Hospital Peking University Health Science Center, Department of Rheumatology and Immunology, Beijing, China
11University of Malaya, Department of Medicine, Faculty of Medicine, Kuala Lumpur, Malaysia
12Tokyo Women’s Medical University, Institute of Rheumatology, Tokyo, Japan
13Peking University First Hospital, Rheumatology and Immunology department, Beijing, China
14Keio University, Division of Rheumatology, Department of Internal Medicine, School of Medicine, Tokyo, Japan
15Teaching Hospital Kandy, Division of Nephrology, Kandy, Sri Lanka
16Flinders Medical Centre, Department of Rheumatology, Bedford Park, Australia
17Royal Adelaide Hospital, Rheumatology Unit, North Terrace, SA, Australia
18Tan Tock Seng Hospital, Department of Rheumatology, Allergy & Immunology, Tan Tock Seng, Singapore
19North Shore Hospital, Department of Medicine, Auckland, New Zealand
20Hanyang University Hospital for Rheumatic Diseases, Department of Rheumatology, Seoul, Korea, Republic of (South Korea)
21St. Vincent’s Hospital, Melbourne, Department of Rheumatology, Melbourne, Australia
22Liverpool Hospital, Rheumatology department, Sydney, Australia
23Middlemore Hospital, Department of Rheumatology, Auckland, New Zealand
24Greenlane Clinical Centre, Department of Rheumatology, Auckland, New Zealand
25University of Occupational and Environmental Health, The First Department of Internal Medicine, Kitakyushu, Japan
26St. Vincent’s Hospital, Department of Rheumatology, Melbourne

Background: The recent prospectively validated definition of the lupus low disease activity state (LLDAS) allows characterisation of patients not achieving a treatment goal, providing impetus for an analysis of unmet needs in SLE using formal definitions. Other recently described definitions of high disease burden include disease activity over time, high disease activity status (HDAS) episodes, and the combination of high disease activity, serological activity and glucocorticoid (GC) use (HDAS+SA+GC).


Objectives: To determine the prevalence of formal categories of unmet need, and the association of these with adverse outcomes, in SLE.


Methods: Data from a 13-country longitudinal SLE cohort (ACR/SLICC criteria) were collected between 2013 and 19 using standard templates. Unmet need was defined as (i) patients never attaining LLDAS defined as in Golder et al. , 2019 [1], (ii) having persistently active disease (time adjusted mean SLEDAI-2K (AMS) > 4), (iii) ever exhibiting high disease activity status (HDAS; SLEDAI-2K ≥10[2]), or (iv) ever exhibiting all of SLEDAI≥10, serological activity, and glucocorticoid use (HDAS+SA+GC)[3]. Health-related quality of life (HRQoL) was assessed using SF36 (v2) surveys and damage accrual using SLE Damage Index (SDI).


Results: 3,384 SLE patients were followed for 30,313 visits over median [IQR] 2.4 [0.4, 4.3] years. 53% of all visits were not in LLDAS; 813 patients (24%) never achieved LLDAS during observation. Median AMS was 3.0 [1.4, 4.9] and 34% of patients had AMS > 4 throughout the study. 25% of patients had at least one episode of HDAS, representing 8% of visits. 702 patients (21%) had at least one episode of HDAS+SA+GC, representing 8% of visits. Each of never-LLDAS, AMS>4, ever-HDAS, and ever-HDAS+SA+GC were associated with significantly greater number of physician visits, higher mean glucocorticoid dose, lower HRQoL and higher mortality. 31%, 58% and 83% of never-LLDAS, AMS>4, and ever-HDAS patients respectively were also HDAS+SA+GC on at least one occasion.


Conclusion: Data from a multinational longitudinal SLE cohort indicate that unmet need, defined by LLDAS-never, AMS>4, HDAS, or HDAS+SA+GC, is prevalent in SLE, and that these definitions are associated with poor outcomes.


REFERENCES:

[1]Golder, V., et al., Lupus low disease activity state as a treatment endpoint for systemic lupus erythematosus: a prospective validation study. The Lancet Rheumatology, 2019. 1 (2): p. e95-e102.

[2]Koelmeyer, R., et al., High disease activity status suggests more severe disease and damage accrual in systemic lupus erythematosus. Lupus Sci Med, 2020. 7 (1).

[3]van Vollenhoven, R.F., et al., Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Annals of the Rheumatic Diseases, 2012. 71 (8): p. 1343-1349.


Acknowledgements: The APLC acknowledges all the Data Collectors and Patients for their valuable contributions to research.


Disclosure of Interests: Rangi Kandane-Rathnayake: None declared, Worawit Louthrenoo: None declared, Alberta Hoi Consultant of: Abbvie and GSK, Grant/research support from: AstraZeneca, GSK, BMS, Janssen, and Merck Serono, Vera Golder: None declared, Yi-Hsing Chen Speakers bureau: Pfizer, Novartis, Abbvie, Johnson & Johnson, BMS, Roche, Lilly, AstraZeneca, Sanofi, MSD, Guigai, Astellas, Inova Diagnostics, UCB, Agnitio Science Technology, United Biopharma, Thermo Fisher, Consultant of: Pfizer, Novartis, Abbvie, Johnson & Johnson, BMS, Roche, Lilly, AstraZeneca, Sanofi, MSD, Guigai, Astellas, Inova Diagnostics, UCB, Agnitio Science Technology, United Biopharma, Thermo Fisher, Gilead, Grant/research support from: Pfizer, Norvatis, BMS, Abbevie, Johnson & Johnson, Roche, Sanofi, Guigai, Roche, Boehringer Ingelheim, UCB, MSD, Astra-Zeneca, Astellas, Gilead, Shue Fen Luo: None declared, Yeong-Jian Jan Wu Speakers bureau: Pfizer, Lilly, Novartis, Abbvie, Aisha Lateef: None declared, Jiacai Cho: None declared, Laniyati Hamijoyo Speakers bureau: Pfizer, Novartis, Abbot, Chak Sing Lau Shareholder of: Pfizer, Sanofi, and Janssen, Sandra Navarra Speakers bureau: Pfizer, Johnson & Johnson, Novartis, Astellas, Grant/research support from: Astellas, Johnson & Johnson, Leonid Zamora: None declared, Zhanguo Li Speakers bureau: Eli, Lilly, Novartis, GSK, AbbVie, Paid instructor for: Pfizer, Roche, Johnson., Consultant of: Lilly, Pfizer, Grant/research support from: Pfizer, Yuan An: None declared, Sargunan Sockalingam Speakers bureau: Pfizer, Roche, Novartis, Grant/research support from: Roche and Novartis, Yasuhiro Katsumata Speakers bureau: Chugai Pharmaceutical Co., Ltd., Glaxo-Smithkline K.K., and Sanofi K.K., 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., and Teijin Pharma Ltd., Consultant of: AbbVie, Boehringer-ingelheim, Bristol Myers Squibb Co., Kissei Pharmaceutical Co.,Ltd. and 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., and Teijin Pharma Ltd., Yanjie Hao: None declared, Zhuoli Zhang Speakers bureau: Norvatis, GSK, Pfizer, Jun Kikuchi: None declared, Tsutomu Takeuchi Speakers bureau: AbbVie AYUMI Pharmaceutical Corp. Bristol-Myers Squibb Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan, Gilead Sciences, Inc. Mitsubishi-Tanabe Pharma Corp. Pfizer Japan Inc. Sanofi K.K., Consultant of: Astellas Pharma, Inc. Chugai Pharmaceutical Co, Ltd. Eli Lilly Japan, Mitsubishi-Tanabe Pharma Corp., Grant/research support from: AbbVie, Asahikasei Pharma Corp. Chugai Pharmaceutical Co, Ltd. Mitsubishi-Tanabe Pharma Corp. Sanofi K.K., BMDB Basnayake: None declared, Fiona Goldblatt: None declared, Madelynn Chan Speakers bureau: AbbVie, Novartis, Consultant of: Pfizer, Eli-Lilly, Kristine Ng Speakers bureau: Abbvie, Novartis, Janssen, Sang-Cheol Bae: None declared, Shereen Oon: None declared, Sean O’Neill Consultant of: GSK, Kathryn Gibson Speakers bureau: UCB, Consultant of: Novartis, Janssen, Grant/research support from: Novartis, Sunil Kumar: None declared, Nicola Tugnet: None declared, Yoshiya Tanaka Speakers bureau: Daiichi-Sankyo, Eli Lilly, Novartis, YL Biologics, Bristol-Myers, Eisai, Chugai, Abbvie, Astellas, Pfizer, Sanofi, Asahi-kasei, GSK, Mitsubishi-Tanabe, Gilead, Janssen, Grant/research support from: Abbvie, Mitsubishi-Tanabe, Chugai, Asahi-Kasei, Eisai, Takeda, Daiichi-Sankyo, Mandana Nikpour Speakers bureau: Actelion, GSK, Janssen, Pfizer, UCB, Paid instructor for: UCB, Consultant of: Actelion, 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, Paid instructor for: Eli Lilly, Consultant of: AstraZeneca, Amgen, Biogen, BristolMyersSquibb, Eli Lilly, EMD Serono, Genentech, Janssen, Grant/research support from: AstraZeneca, BristolMyersSquibb, Eli Lilly, EMD Serono, Janssen.

Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 218
Session: Epidemiology: Big Questions - Big studies (Poster Tours)