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Abstract Number: 1257

Improvements in Abnormal Laboratory Tests Are Associated with Clinical Outcomes in Patients with Active Systemic Lupus Erythematosus

Kathryn Connelly1, Rangi Kandane-Rathnayake1, Alberta Hoi2, Worawit Louthrenoo3, Laniyati Hamijoyo4, Jiacai Cho5, Aisha Lateef6, Shue-Fen Luo7, Yeong-Jian Wu8, Zhanguo Li9, Yuan An9, Sandra Navarra10, Leonid Zamora10, Sargunan Sockalingam11, Yanjie Hao12, Zhuoli Zhang12, Yasuhiro Katsumata13, Masayoshi Harigai13, Shereen Oon14, Madelynn Chan15, YI-HSING CHEN16, Sang-Cheol Bae17, Sean O’Neill18, Kathryn Gibson18, Fiona Goldblatt19, Jun Kikuchi20, Tsutomu Takeuchi21, Kristine (Pek Ling) Ng22, Nicola Tugnet23, B.M.D.B. Basnayake24, Yoshiya Tanaka25, C.S. Lau26, Mandana Nikpour27, Vera Golder1 and Eric Morand28, 1Monash University, Clayton, Australia, 2Department of Rheumatology, Monash Health & Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia, 3Maharaj Nakorn Chiangmai, Chiang Mai, Thailand, 4University of Padjadjaran, Bandung, Indonesia, 5National University Health System (NUHS), Singapore, Singapore, 6National University Hospital, Singapore, Singapore, 7Chang Gung Memorial Hospital, Taipei, Taiwan, 8Chang Gung Memorial Hospital, Taoyuan County, Taiwan, 9People's Hospital, Peking University Health Science Center, Beijing, China (People's Republic), 10University of Santo Tomas Hospital, Manila, Philippines, 11University of Malaya, Kuala Lumpur, Malaysia, 12Peking University First Hospital, Beijing, China (People's Republic), 13Tokyo Women's Medical University School of Medicine, Tokyo, Japan, 14Melbourne Health, Parkville, Australia, 15Tan Tock Seng Hospital, Singapore, Singapore, 16Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), 17Hanyang University Medical Center, Seoul, Republic of Korea, 18Liverpool Hospital, Sydney, Australia, 19Flinders Medical Centre, Adelaide, Australia, 20Keio University School of Medicine, Tokyo, Japan, 21Div. Rheumatology, Keio University, Tokyo, Japan, 22North Shore Hospital, Auckland, New Zealand, 23Auckland District Health Board, Auckland, New Zealand, 24Teaching (General) Hospital, Kandy, Sri Lanka, 25University of Occupational and Environmental Health, Kitakyushu, Japan, 26University of Hong Kong, Hong Kong, Hong Kong, 27University of Melbourne at St Vincent's Hospital, Melbourne, Australia, 28School of Clinical Sciences at Monash Health, Monash University Faculty of Medicine, Nursing and Health Sciences, Monash Medical Centre Clayton, Melbourne, Australia

Meeting: ACR Convergence 2021

Keywords: longitudinal studies, Outcome measures, Systemic lupus erythematosus (SLE)

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Session Information

Date: Monday, November 8, 2021

Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster III: Outcomes (1257–1303)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Laboratory tests are routine in the management of SLE. In clinical trial endpoints, data from laboratory tests contribute to responder status, but this is captured using discrete thresholds rather than continuous data. We investigated whether the trajectory of abnormal laboratory tests in patients with active SLE, measured as continuous data, corresponds with conventional measures of clinical improvement.

Methods: We used clinical and laboratory data from a large multinational prospectively followed longitudinal cohort. Eligible patients had active disease (SLEDAI-2K ≥6), and at least one abnormal routine laboratory test (haemoglobin, white cell count, lymphocytes, platelets, ESR, albumin, C3, C4, anti-dsDNA, and urine protein, red cells or white cells), at a visit designated as baseline. At 12 months thereafter, for each laboratory test we classified improvement from individual patient baselines as complete response (CR; 100% improvement i.e. restoration to normal range), partial response (PR; ≥ 20-< 100% improvement) or no response (NR; < 20% improvement)) and assessed associations with a range of improvement outcomes: modified SLE responder index (omitting BILAG criteria) (mSRI4), physician global assessment (PGA) improvement ≥ 0.3, attainment of lupus low disease activity state (LLDAS (Golder, 2019)), SLE flare index (SFI) and SLICC/ACR damage index accrual (SDI increase >0), using logistic regression.

Results: 1,525 patients were included, with separate subsets for each individual abnormal laboratory test. Most patients were female (93%), Asian (88%) and had established SLE. Associations (odds ratios, 95% confidence intervals and significance) of laboratory variable CR and PR with clinical outcomes at 12 months are shown in Figure 1. Improvement in proteinuria, albumin, haemoglobin, ESR and platelets had the strongest associations with clinical improvement measures, including increased odds of LLDAS attainment and protection against damage accrual. In contrast, serology was associated only with the less stringent outcomes of PGA improvement and mSRI4. White cell count and lymphocytes had the weakest associations with improvement measures. Although CR had stronger associations, PR of certain laboratory tests also conferred benefit.

Conclusion: Improvements in abnormal laboratory tests were predictive of clinical outcomes at 12 months, with a discrepancy between tests currently incorporated in clinical trial endpoints, such as serology, and those with the strongest associations with clinical outcomes. Associations with improved clinical outcomes were associated with improvement thresholds less stringent than complete resolution for some tests. The selection, weighting and threshold-based use of laboratory tests in lupus trial endpoints should be revised.

Figure 1: Associations of partial and complete improvement in abnormal laboratory tests between baseline and 12 months, and corresponding clinical improvement outcomes.


Disclosures: K. Connelly, Janssen, 6; R. Kandane-Rathnayake, None; A. Hoi, AstraZeneca, 2, 5, Janssen, 6, Abbvie, 6; W. Louthrenoo, None; L. Hamijoyo, None; J. Cho, None; A. Lateef, None; S. Luo, None; Y. Wu, None; Z. Li, None; Y. An, None; S. Navarra, Biogen, 2, Boehringer Ingelheim, 6, Pfizer, 6, Novartis, 6, Johnson & Johnson, 6; L. Zamora, None; S. Sockalingam, None; Y. Hao, None; Z. Zhang, None; Y. Katsumata, Glaxo-Smithkline K.K., 6, Sanofi K.K., 6, AstraZeneca K.K., 6, Chugai Pharmaceutical Co., Ltd., 6, Pfizer Japan Inc., 6, Astellas Pharma Inc., 6, Mitsubishi Tanabe Pharma Corporation, 6, Janssen Pharmaceutical K.K., 6; M. Harigai, None; S. Oon, Janssen, 6; M. Chan, DKSH, 1, 6, Johnson & Johnson, 1, AbbVie, 12, EULAR Congress 2021 registration fee; Y. CHEN, None; S. Bae, None; S. O’Neill, None; K. Gibson, Eli Lilly, 3; F. Goldblatt, None; J. Kikuchi, None; T. Takeuchi, Astellas Pharma, 2, 5, 6, Chugai Pharmaceutical, 2, 5, 6, Asahi Kasei Pharma, 5, Mitsubishi Tanabe, 2, 5, 6, AbbVie, 5, 6, Daiichi Sankyo, 5, 6, Eisai, 5, 6, Shionogi, 5, Takeda, 5, UCB Japan, 5, Eli Lilly Japan, 2, 6, AYUMI, 6, Bristol-Myers Squibb, 6, Gilead Sciences, Inc., 6, Novartis, 6, Pfizer Japan, 6, Sanofi, 6, Dainippon Sumitomo, 6; K. Ng, None; N. Tugnet, None; B. Basnayake, None; Y. Tanaka, Daiichi-Sankyo, 2, 5, 6, Eli Lilly, 6, Novartis, 6, YL Biologics, 6, Bristol-Myers Squibb, 6, Eisai, 5, 6, Chugai, 5, 6, AbbVie, 2, 5, 6, Astellas, 6, Pfizer, 6, Sanofi, 2, 6, Asahi-kasei, 5, 6, GSK, 2, 6, Mitsubishi-Tanabe, 5, 6, Gilead, 6, Janssen, 6, Takeda, 5, Ayumi, 2, Taisho, 2; C. Lau, None; M. Nikpour, None; V. Golder, None; E. Morand, Amgen, 2, AbbVie, 2, Biogen, 2, Bristol Myers Squibb, 2, 5, AstraZeneca, 2, 5, 6, Genentech, 2, Servier, 2, Capella Biosciences, 2, Eli Lilly, 5, 6, EMD Serono, 5, 6, Janssen, 2, 5, UCB, 2, GlaxoSmithKline, 2, 5.

To cite this abstract in AMA style:

Connelly K, Kandane-Rathnayake R, Hoi A, Louthrenoo W, Hamijoyo L, Cho J, Lateef A, Luo S, Wu Y, Li Z, An Y, Navarra S, Zamora L, Sockalingam S, Hao Y, Zhang Z, Katsumata Y, Harigai M, Oon S, Chan M, CHEN Y, Bae S, O’Neill S, Gibson K, Goldblatt F, Kikuchi J, Takeuchi T, Ng K, Tugnet N, Basnayake B, Tanaka Y, Lau C, Nikpour M, Golder V, Morand E. Improvements in Abnormal Laboratory Tests Are Associated with Clinical Outcomes in Patients with Active Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/improvements-in-abnormal-laboratory-tests-are-associated-with-clinical-outcomes-in-patients-with-active-systemic-lupus-erythematosus/. Accessed January 30, 2023.
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