Background After achieving low disease activity/remission, immunosuppressant (IS) therapy might be stopped, but information on whether and how this should be done is limited.
Objectives To determine if stopping IS in patients in remission is possible without triggering flare.
Methods Analysis was conducted on all patients seen in The Lupus Clinic in whom IS was tapered and stopped. Inclusion criteria: 1) in clinical remission (no activity in the clinical SLEDAI-2K descriptors and absence of proteinuria or lupus related thrombocytopenia and leukopenia) and 2) prednisone ≤7.5mg/day.
Three time points are identified in each patient: 1) Tapering start - defined as the first visit with a decrease of at least 25% in the dose of IS 2) IS Stop - defined as the day when IS was completely stopped 3) Study end - defined as the date of flare or last clinic visit following IS stop. Study endpoints: Flare - Introduction of new IS or any increase of prednisone dosage in the context of clinically active lupus. Flare was evaluated within the first 2 years from IS stop and also at any time after IS stop. Descriptive statistics were used. Patients who flared within 2 years were compared to those who did not (t-test and χ2 tests). Kaplan-Meier curve was used to evaluate the time to flare after IS stop.
Results Of the 1678 patients registered at the Lupus Clinic, 973 were ever on IS and 99 stopped IS [56 azathioprine (AZA); 25 methotrexate (MTX), 18 mycophenolate mofetil (MMF)]. At tapering start, mean age was 40.4± 13.1 and mean disease duration was 11.4±9.4 years. The length of time from tapering start to IS stop was 1.5±1.7 years (Median=0.9). Of the 99 patients, 25 flared within 2 years (16 on AZA; 7 on MTX and 2 on MMF; p=0.31). 46 of the patients had follow up available beyond 2 years; 32 were followed beyond 3 years, 26 beyond 4 years and 24 beyond 5 years. 17 patients experienced a flared after year 2.
Comparing patients who flared within 2 years to those who did not, the percentage of patients with positive serology at the time of IS stop was greater in those who flared, 68 compared to 41% (Table 1). Time from Tapering start to IS stop was 1.8±1.8 years in the no flare group and 0.9±0.9 years in the flare group (p=0.002). Using KM curve for time to flare (Figure 1) showed that at 1, 2, 3, 4 and 5 years, the percent of patients who flared was 17%, 30%, 46%, 49% and 51% respectively.
Conclusions Within 2 years, successful stopping of IS is possible in about 70% of clinically stable patients. Half were successful within 3 year and this proportion was stable up to 5 years. Patients who discontinued IS slowly are less likely to flare within 2 years. At the time of IS stop, serologically active patients were more likely to flare on follow-up visits.
Disclosure of Interest None declared