Background and objectives There is only one biologic agent approved for use in SLE, but some are used off-label in various settings. To obtain information systematically regarding this, members of the SLICC group initiated the International Registry for Biologics in SLE (IRBIS). The objective of this study was to analyse the use of biologics in SLE, and assess results achieved with the most commonly used off-label biologic, rituximab (RTX). Materials and methods IRBIS investigators were asked to provide retrospective data on all patients treated with a biologic for SLE at their center. Standardised case report forms were used to collect demographic, disease-specifi c and treatment data at the time of biologic initiation and at yearly follow-up. Data from the fi rst 23 reporting centers are presented. Results Three hundred and fi fty-nine patients were treated off-label with RTX, and additional groups of patients were exposed to belimumab (n=44), epratuzumab (n=21), abatacept (n=4), etanercept (n=3) and adalimumab (n=1). For the RTX treated group, age (mean±SD) was 41.3±13.3 and 91% were female. The majority (76%) were Caucasian, and smaller proportions were Southeast Asian, Asian/Indian, AfricanAmerican, Latino, Afro-Caribbean or other (each <10%). Disease duration when RTX was initiated was 9.2±7.8 years. SLEDAI at start was 11.3±7.6, SLICC-damage index 1.4±1.5 and glucocorticoid dosage 17.0±15.2 mg. Most patients (78%) had been treated with one or two different immunosuppressives (ISs) prior to RTX, and the remaining with three to fi ve ISs. Two dosing regimens were used for RTX: 375 mg/m2x4 (52%) and 1000 mgx2 (48%). The major organ manifestations leading to RTX treatment were lupus nephritis (LN, 48%), haematological (21%), musculoskeletal, skin disease, CNS and other (each <10%). At 1-year follow-up both SLEDAI and GC dose had decreased (4.2±3.5 (n=106) and 7.9±7.0mg (n=89), respectively, paired samples, p<0.0001 for both comparisons). Exclusion of patients started on additional ISs (n=24) did not change SLEDAI or GC dose signifi cantly. SLEDAI at baseline was higher in LN than in non-LN patients but similar at follow-up. Overall, the 1000 mgx2 was more often used but both dosing regimens appeared equally effective in LN. Conclusions RTX was the off-label biologic most commonly used in this multi-center international lupus cohort and was used for LN as well as for other SLE manifestations. At oneyear-follow-up both lupus activity and concomitant glucocorticoid dosage had decreased even when no other IS treatments had been introduced. The two RTX dosing regimes appeared equally effective for LN treatment, but fi rm conclusions cannot be made from these observational data.on 29 August 2018 by guest. Protected by copyright.
Background Only one biologic agent has been approved for use in SLE, but some are used off-label in various settings. To obtain information systematically regarding this, members of the SLICC group initiated the International Registry for Biologics in SLE (IRBIS). The entire registry contains data from 28 centers. Objectives To analyse the use of biologics in SLE, and assess the results achieved over the first two years after initiation. Methods IRBIS investigators provided retrospective data on all patients treated with a biologic for SLE at their center. Standardized case report forms were used to collect demographic, disease-specific and treatment data at the time of biologic initiation and at yearly follow-ups. Here, data is presented from 13 reporting centers for which two-year follow-up data were available. Results Based on the complete data set, 455 patients were treated with rituximab (84%), belimumab (10%), epratuzumab (5%), and anti-tumor necrosis factor agents (abatacept, etanercept and adalimumab, each <1%). The major organ manifestations leading to biologic treatment were lupus nephritis (LN, 44%), hematological (17%), musculoskeletal (16%), skin disease (10%), CNS (4%) and other (9%). Reasons for choosing the biologic were disease-control (73%), steroid-sparing (5%) or both (23%). At biologic initiation mean disease duration (±SD) was 9.5±7.9 years, and mean age was 42.2±12.5. Most patients (91%) were female. Prior to biologic treatment, most patients (91%) had been treated with one or more immunosuppressants (IS). Just over half (57%) had used 1-2 IS drugs, 21% had used three, and 13% had used 4-6 IS drugs. At two-year follow-up (n=120), SLE disease activity (SLEDAI) and glucocorticoid (GC) dose was significantly lower versus baseline (mean±SD SLEDAI: 9.4±5.3 to 3.1±2.5; mean±SD GC dose: 10.7±13.9 to 4.8±5.9 mg; paired analyses, p<0.0001 for both comparisons). SLICC damage-index remained unchanged. At baseline, concomitant GC was used in 91% of patients compared to 61% at follow-up. There was a slight trend to decreasing use of IS drugs from baseline (57%) to follow-up (51%). In almost half of patients (48%) there was at least one adverse event reported over the indicated follow-up period. However, only 5% were related to the biologic agent. Serious adverse events were serious opportunistic infections (n=4), posterior reversible encephalopathy syndrome (PRES, 3), serious allergic reactions (4), serious infections (6) and death (6). Conclusions Rituximab was the biologic used most commonly in this multi-center international lupus cohort and was used for a range of SLE manifestations. At two-year follow-up both lupus activity and concomitant glucocorticoid dosage had decreased. Over time, GC use decreased, with a trend for a decrease in IS drug use as well. Disclosure of Interest None Declared
Background Rituximab (Mabthera; RTX) has not been approved for use in SLE, but uncontrolled observations have suggested efficacy in some patients and the medication can be used off-label in many European countries. We previously reported that based on data from the International Registry for Biologics in SLE (IRBIS), and additional data from investigators, between 0.5 and 1.3% of European patients with SLE have been treated, off-label, with RTX. Objectives To compare characteristics of SLE patients treated off-label with RTX to those of SLE patients treated with conventional, non-biologic immunosuppressives (ISs) at the same specialty centers. Methods Investigators participating in IRBIS, initiated by the SLICC group, provided the data for this study. Data previously submitted to the IRBIS registry by 28 centers in 11 European countries were complemented with additional clinical information from the participating sites. Comparator patients were those started on any conventional IS; not necessarily naïve for previous ISs. Results In this European study, 175 patients were analyzed; 103 were treated off-label with RTX and 72 with conventional ISs. The most frequently used ISs were mycophenolate mofetil (43%) and azathioprine (33%). For both groups, about 90% were female, 90% were Caucasians and 85% were non-smokers. Organ manifestations leading to treatment with RTX were lupus nephritis in 58%, hematological lupus in 16%, musculoskeletal in 11%, skin disease in 6%, CNS in 7%, and other manifestations in 7%. For patients started on ISs, the corresponding percentages were 53%, 11%, 22%, 6%, 7%, and 6%. These distributions were not statistically different. Reason for treatment initiation with RTX was mainly disease control while steroid sparing was frequently the main reason for conventional ISs. At treatment initiation mean disease duration (±SD) was 9.1±7.0 for RTX-treated patients and 4.1±6.6 for patients on ISs (p<0.0001); mean ages were 41.2±12.5 and 36.1±11.3, respectively (p=0.007). There were significant differences between the groups for SLEDAI scores (12.2±7.0 vs. 9.4±7.0, p=001) and SLICC damage index (1.6±3.4 vs. 0.57±1.0, p=0.014). Conclusions Both RTX and conventional ISs are used mostly in lupus nephritis. No organ manifestion was more likely to be treated with RTX, however, patients started on RTX were somewhat older, had significantly longer disease duration, higher disease activity and more damage compared to patients started on conventional ISs. These data support the view that RTX is used for selected patients with later-stage, more severe SLE. Acknowledgements Supported by a research grant from Roche Disclosure of Interest None Declared
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