Association of Modified Systemic Lupus Erythematosus Responder Index Attainment With Long-Term Clinical Outcomes: A Five-Year Prospective Study

Connelly K 1 , Kandane-Rathnayake R 1 , Hoi A 1 , Louthrenoo W 2 , Hamijoyo L 3 , Luo SF 4 Show all authors , Wu YJ 4 , Cho J 5 , Lateef A 5 , Lau CS 6 , Chen YH 7 , Navarra S 8 , Zamora L 8 , Li Z 9 , An Y 9 , Sockalingam S 10 , Hao Y 11 , Zhang Z 12 , Chan M 13 , Katsumata Y 13 , Harigai M 13 , Oon S 14 , Bae SC 15 , O'Neill S 16 , Gibson KA 17 , Basnayake B 18 , Kikuchi J 19 , Takeuchi T 19 , Ng KPL 20 , Tugnet N 21 , Kumar S 22 , Goldblatt F 23 , Law A 24 , Tee M 25 , Tee C 25 , Tanaka Y 26 , Ohkubo N 26 , Tan JY 27 , Karyekar CS 28 , Nikpour M 14 , Golder V 1 , Morand EF 1

Affiliations 

  • 1 School of Clinical Sciences, Monash University, Clayton, Victoria, Australia
  • 2 Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital, Chiang Mai, Thailand
  • 3 Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/Hasan Sadikin General Hospital, Bandung, Indonesia
  • 4 Department of Rheumatology, Allergy and Immunology, Chang Gung Memorial Hospital, Taipei and Keelung, Taiwan
  • 5 Rheumatology Division, University Medical Cluster, National University Hospital, Singapore
  • 6 Department of Medicine, University of Hong Kong, Hong Kong
  • 7 Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan
  • 8 Joint and Bone Center, University of Santo Tomas Hospital, Manila, Philippines
  • 9 Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center, Beijing, China
  • 10 Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 11 Department of Rheumatology and Immunology, Peking University First Hospital, Beijing, China
  • 12 Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital, Singapore
  • 13 Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University School of Medicine
  • 14 Department of Rheumatology, St. Vincent's Hospital, Melbourne, Victoria, Australia
  • 15 Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases and Hanyang University Institute for Rheumatology Research, Seoul, Korea
  • 16 Rheumatology Department, Liverpool Hospital, and University of New South Wales and Ingham Institute of Applied Medical Research, Liverpool, New South Wales, Australia
  • 17 Rheumatology Department, Liverpool Hospital, Liverpool, New South Wales, Australia
  • 18 Division of Nephrology, Teaching Hospital, Kandy, Sri Lanka
  • 19 Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan
  • 20 Waitemata District Health Board, Auckland, New Zealand
  • 21 Auckland District Health Board, Auckland, New Zealand
  • 22 Middlemore Hospital, Auckland, New Zealand
  • 23 Department of Rheumatology, Flinders Medical Centre, Bedford Park, and Rheumatology Unit, Royal Adelaide Hospital, North Terrace, South Australia, Australia
  • 24 Singapore General Hospital, Singapore
  • 25 University of the Philippines, Manila, Philippines
  • 26 The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  • 27 Janssen Asia Pacific, Singapore
  • 28 Janssen Research & Development, Spring House, Pennsylvania
Arthritis Rheumatol, 2023 Mar;75(3):401-410.
PMID: 36122172 DOI: 10.1002/art.42350

Abstract

OBJECTIVE: In trials of systemic lupus erythematosus (SLE), the SLE Responder Index (SRI) is the most commonly used primary efficacy end point but has limited validation against long-term outcomes. We aimed to investigate associations of attainment of a modified version of the SRI (mSRI) with key clinical outcomes in SLE patients with up to 5 years of follow-up.

METHODS: We used data from a large multicenter, longitudinal SLE cohort in which patients received standard of care. The first visit with active disease (defined as SLE Disease Activity Index 2000 [SLEDAI-2K] score ≥6) was designated as baseline, and mSRI attainment (defined as a reduction in SLEDAI-2K ≥4 points with no worsening in physician global assessment ≥0.3 points) was determined at annual intervals from baseline up to 5 years. Associations between mSRI attainment and outcomes including disease activity, glucocorticoid dose, flare, damage accrual, Lupus Low Disease Activity State (LLDAS), and remission were studied.

RESULTS: We included 2,060 patients, with a median baseline SLEDAI-2K score of 8. An mSRI response was attained by 56% of patients at 1 year, with similar responder rates seen at subsequent annual time points. Compared to nonresponders, mSRI responders had significantly lower disease activity and prednisolone dose and higher proportions of LLDAS and remission attainment at each year, and less damage accrual at years 2 and 3. Furthermore, mSRI responder status at 1 year predicted clinical benefit at subsequent years across most outcomes, including damage accrual (odds ratio [OR] range 0.58-0.69, P 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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