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OBJECTIVES: There are limited real-life data regarding the efficacy and safety of rituximab (RTX) as a remission-maintenance agent in microscopic-polyangiitis (ΜPA) and granulomatosis-with-polyangiitis (GPA). We aimed to estimate the incidence and risk factors for relapses, as well serious-adverse-events (SAEs) in MPA/GPA patients during RTX-maintenance. METHODS: Retrospective cohort of newly-diagnosed/relapsing GPA/MPA patients who received RTX-maintenance (≥1 RTX-cycle, ≥6 months follow-up) following complete-remission (Birmingham-Vasculitis-Activity-Score-version-3 = 0 plus prednisolone ≤7.5 mg/day) with induction regimens. SAEs included serious-infections, COVID-19-associated hospitalizations, deaths, cardiovascular-events, malignancies and hypogammaglobulinemia. Incidence-rates (IR) and relapse-free survival through Kaplan-Meier plots were estimated. Cox-regression was conducted to investigate factors associated with the time-to-relapse. RESULTS: 101 patients were included; 48% females, 69% GPA, 53% newly diagnosed, median age: 63 years. During follow-up (294.5 patient-years, median: 3 RTX-cycles), 30 relapses (57% major) occurred among 24 patients (24%, IR 10.2/100 patient-years). Kidney involvement (adjusted-Hazard-Ratio/aHR: 0.20; 95% CI: 0.06-0.74, p= 0.016), prior induction with RTX plus cyclophosphamide (vs RTX monotherapy: aHR = 0.02; 95% CI: 0.001-0.43, p= 0.012) and shorter time-interval until complete-remission (aHR = 1.07; 95% CI: 1.01-1.14, p= 0.023) were associated with decreased relapse-risk. We recorded 17 serious-infections (IR 5.8/100 patient-years), 11 COVID-19-associated hospitalizations (IR 3.7/100 patient-years), 4 malignancies (IR 1.4/100 patient-years), 6 cardiovascular-events (IR 2/100 patient-years) and 10 deaths (IR 3.4/100 patient-years). CONCLUSION: In this real-world study, relapses during RTX-maintenance occurred in approximately in 1 out of 4 patients. Kidney involvement, induction with RTX plus cyclophosphamide and earlier achievement of complete-remission were associated with lower relapse-risk. Serious-infections rate was consistent with previous reports, whereas an increased rate of COVID19-associated hospitalizations was observed.
RESUMO
BACKGROUND/OBJECTIVE: Data on risk factors predicting uveitis development in spondyloarthritis (SpA) is scarce. Our aim was to examine associations between demographic, clinical and/or laboratory characteristics of SpA with the occurrence and the course of uveitis, including ocular damage and recurrence rate. METHODS: Characteristics (at disease diagnosis and ever-present) from axSpA and Psoriatic arthritis (PsA) patients followed in 3 tertiary rheumatology-clinics were retrospectively recorded. Comparisons were made between patients with and without uveitis, as well as between those with uveitis-rate [episodes/year] above the median uveitis-rate in the whole cohort ("recurrent"-uveitis) and the remaining uveitis patients ("non-recurrent uveitis"). In multivariable models, age, gender and variables significantly different in univariate analyses were included. RESULTS: 264 axSpA and 369 PsA patients were enrolled. In axSpA, uveitis occurred in 11.7% and was associated with HLA-B27 (OR = 4.15, 95%CI 1.16-14.80, p = 0.028) and ever-present peripheral arthritis (OR = 3.05 (1.10-8.41, p = 0.031). In contrast, uveitis in PsA occurred only in 2.7% of patients and was associated with SpA family-history (OR = 6.35 (1.29-31.27), p = 0.023) axial disease at diagnosis (OR = 5.61 [1.01-28.69], p = 0.038) and disease duration (OR = 1.12 [1.04-1.21], p = 0.004). Median uveitis recurrence rate was comparable between axSpA and PsA (0.205 and 0.285 episodes/year, respectively). No associations were found between recurrent uveitis and demographic/clinical/laboratory characteristics. Ocular damage (e.g. synechiae) was seen in 16.1% of axSpA and 30% of PsA patients, all of them with recurrent uveitis. CONCLUSION: Uveitis occurred more commonly in axSpA than in PsA patients, while uveitis recurrence rate was similar. Permanent ocular damage may occur more often in PsA than axSpA.