Background/Purpose: The risks and benefits of long-term hydroxychloroquine (HCQ) use in systemic lupus erythematosus (SLE), versus tapering or stopping, remain uncertain. We aimed to identify predictors of a poor outcome once HCQ is tapered or discontinued in SLE.

Methods: We studied a clinical cohort of adult patients meeting ACR classification criteria for SLE. From January 2002 and December 2018, we identified the first visit with HCQ exposure for each patient. We then determined those tapering (sub-cohort 1) or discontinuing (sub-cohort 2) HCQ at a follow-up visit. This follow-up visit represented time zero for the remaining analyses. The primary outcome was time to the first of the following events: a) increase of >4 points in the SLE Disease Activity Index (SLEDAI-2K); b) hospitalization for SLE; and/or c) augmented SLE therapy (i.e. an increase in HCQ, or a new start/increase in corticosteroids or immunosuppressants). Cox regression was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) to determine if baseline characteristics (age at SLE diagnosis, sex, education and race/ethnicity) were associated with our outcome.

Results: We identified 228 patients tapering HCQ (sub-cohort 1) and 188 stopping HCQ (sub-cohort 2). Most patients were female (90%) and white (70%), and the mean±SD age at SLE diagnosis was 32±13 years. The mean±SD follow-up time from our time zero was 6.7±4.4 years in sub-cohort 1 and 5.6±4.7 in sub-cohort 2. Within the first year of observation, 167 (73%) patients who tapered HCQ and 133 (71%) patients who discontinued HCQ had at least one poor outcome. The most common poor outcome was need for therapy augmentation (70% after tapering and 64% after stopping HCQ), followed by SLEDAI-2K increase >4 (37% after tapering and 32% after stopping HCQ) and hospitalization for SLE (7% after tapering and 8% after stopping HCQ). Patients with higher age at SLE diagnosis and those with SLEDAI-2K ≥4 and/or requiring prednisone/mycophenolate at baseline were more likely to experience poor outcomes after HCQ discontinuation (Table 1). Patients with renal damage were more likely to have an increase in disease activity after tapering HCQ (adjusted HR: 2.02; 95%CI: 1.13, 3.62).

Conclusion: Though some SLE patients do well after tapering or discontinuing HQN, others have poor outcomes including SLE-related hospitalization. Our results suggest caution in tapering or discontinuation of HCQ in some groups of SLE patients, such as those with renal damage, unstable disease activity, or requiring prednisone/mycophenolate. The identification of these predictors is an important approach to promote personalized medicine.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/identification-of-sle-subgroups-at-risk-for-poor-outcomes-after-hydroxychloroquine-taper-or-discontinuation/