ABSTRACT
Background: Patients with systemic lupus erythematosus (SLE) are at an increased risk of infection relative to the general population. We aimed to describe the frequency and risk factors for serious infections in patients with moderate-to-severe SLE treated with rituximab, belimumab, and standard of care therapies in a large national observational cohort. Method(s): The British Isles Lupus Assessment Group Biologics Register (BILAG-BR) is a UK-based prospective register of patients with SLE. Patients were recruited by their treating physician as part of their scheduled care from 64 centres across the UK by use of a standardised case report form. Inclusion criteria for the BILAG-BR included age older than 5 years, ability to provide informed consent, a diagnosis of SLE, and starting a new biological therapy within the last 12 months or a new standard of care drug within the last month. The primary outcome for this study was the rate of serious infections within the first 12 months of therapy. Serious infections were defined as those requiring intravenous antibiotic treatment, hospital admission, or resulting in morbidity or death. Infection and mortality data were collected from study centres and further mortality data were collected from the UK Office for National Statistics. The relationship between serious infection and drug type was analysed using a multiple-failure Cox proportional hazards model. Finding(s): Between July 1, 2010, and Feb 23, 2021, 1383 individuals were recruited to the BILAG-BR. 335 patients were excluded from this analysis. The remaining 1048 participants contributed 1002.7 person-years of follow-up and included 746 (71%) participants on rituximab, 119 (11%) participants on belimumab, and 183 (17%) participants on standard of care. The median age of the cohort was 39 years (IQR 30-50), 942 (90%) of 1048 patients were women and 106 (10%) were men. Of the patients with available ethnicity data, 514 (56%) of 911 were White, 169 (19%) were Asian, 161 (18%) were Black, and 67 (7%) were of multiple-mixed or other ethnic backgrounds. 118 serious infections occurred in 76 individuals during the 12-month study period, which included 92 serious infections in 58 individuals on rituximab, eight serious infections in five individuals receiving belimumab, and 18 serious infections in 13 individuals on standard of care. The overall crude incidence rate of serious infection was 117.7 (95% CI 98.3-141.0) per 1000 person-years. Compared with standard of care, the serious infection risk was similar in the rituximab (adjusted hazard ratio [HR] 1.68 [0.60-4.68]) and belimumab groups (1.01 [0.21-4.80]). Across the whole cohort in multivariate analysis, serious infection risk was associated with prednisolone dose (>10 mg;2.38 [95%CI 1.47-3.84]), hypogammaglobulinaemia (<6 g/L;2.16 [1.38-3.37]), and multimorbidity (1.45 [1.17-1.80]). Additional concomitant immunosuppressive use appeared to be associated with a reduced risk (0.60 [0.41-0.90]). We found no significant safety signals regarding atypical infections. Six infection-related deaths occurred at a median of 121 days (IQR 60-151) days from cohort entry. Interpretation(s): In patients with moderate-to-severe SLE, rituximab, belimumab, and standard immunosuppressive therapy have similar serious infection risks. Key risk factors for serious infections included multimorbidity, hypogammaglobulinaemia, and increased glucocorticoid doses. When considering the risk of serious infection, we propose that immunosupppressives, rituximab, and belimumab should be prioritised as mainstay therapies to optimise SLE management and support proactive minimisation of glucocorticoid use. Funding(s): None.Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
ABSTRACT
Background/AimsRheumatology departments were required to switch rapidly from faceto-face (F2F) to remote consultations during the COVID-19 pandemicin the UK. We conducted a patient satisfaction survey on the switch toinform future service development.MethodsAll patients [new (NP), follow-up (FU)] were identified between 1st to5th June 2020. Patients who attended or did not attend (DNA) a prebooked F2F consultation or cancelled were excluded. Of theremainder, half the patients was surveyed by phone using astandardised questionnaire and the other half was posted the samequestionnaire. Both groups were offered the opportunity to completethe survey online. Patients were surveyed on the organisation andcontent of the consultation, whether they were offered a subsequentF2F appointment and future consultation preference.Results233 consultations were scheduled during the study period. After 53exclusions (34 pre-booked F2F, 16 DNA, 3 cancellations), 180 eligibleconsultations were surveyed (85 via mailshot, 95 by telephone). 75/180patients (42%) responded within 1 month of the telephone consultation(20 NP, 47 FU, 8 missing).The organisation of the switch was positively perceived (Table).Patients were highly satisfied with 4 of the 5 consultation domains butwere undecided whether a physical assessment would have changedthe outcome of the consultation (Table).After the initial phone consultation, 7 of 20 NP and 19 of 47 FU werenot offered subsequent F2F appointments at the clinicians' discretion.Of those not offered subsequent F2F appointments, proportionallymore NP (3/7, 43%) would have liked one, compared to FU (5/19, 26%). Reasons included communication difficulties and a desire for adefinitive diagnosis. 48/75 (64%) would be happy for future routine FUto be conducted by phone ''most of the time" or "always'';citingpatient convenience and disease stability. Caveats were if physicalexamination was required or if more serious issues (as perceived bythe patient) needed F2F discussion.ConclusionPatients were generally satisfied with telephone consultations andmost were happy to be reviewed again this way. NPs should beoffered F2F appointments for first visits to maximise patient satisfaction and time efficiency.