What Is New - Systemic Lupus Erythematosus (SLE)
Take a look at our 'What is new' highlights in systemic lupus erythematosus (SLE)!
May 2023
"Early infection risk in patients with systemic lupus erythematosus treated with rituximab or belimumab from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR): a prospective longitudinal study"
Why WIN?
Patients with systemic lupus erythematosus (SLE) are at an increased risk of infection. Using the British Isles Lupus Assessment Group Biologics Register (BILAG-BR), this real-world prospective observational study adds a significant knowledge regarding the frequency and risk factors for serious infections in patients with moderate-to-severe SLE treated with rituximab, belimumab, and standard of care therapies.
Would you support prioritization of immunosupppressives, rituximab, and belimumab over glucocorticoid use taking into consideration the risk of serious infection?
Yes / No
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Link to original article: https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00091-7/fulltext
April 2023
"Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study"
Why WIN?
A recently published study by Tian et al. offers a comprehensive understanding of the epidemiology of SLE around the world. The authors performed a systematic review and meta-analysis, including 112 studies on SLE epidemiology published over 30 years, from 1992 to 2022. In order to estimate incidence and prevalence data for each individual country globally with or without SLE epidemiological data, a Bayesian hierarchical linear mixed model was applied. The study also includes global, regional, and country-specific estimates of the annual population with newly diagnosed SLE and the overall population with SLE.
Do you think new phenotypic subdivisions could be incorporated in the LN classification system?
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March 2023
"Dissecting the histological features of lupus nephritis highlights new common patterns of injury in class III/IV"
Why WINS?
Renal biopsy is a cornerstone for the management of patients with lupus nephritis (LN), as their treatment is strongly guided by the International Society of Nephrology/Renal Pathology Society (ISN/RPS). The Belimumab International Study in LN (BLISS-LN) collected 353 renal biopsies. By cluster analysis, two main groups were distinguished labeled as membranoproliferative-like and vasculitis-like. This study gives an insight into new phenotypic forms of LN challenging the traditional classes. Consequently, this might be the starting point of further investigations and a new therapeutic paradigm in LN.
Do you think new phenotypic subdivisions could be incorporated in the LN classification system?
Share your response with us using the hashtag #WhatIsNew and tag us @EMEUNET
February 2023
" Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus "
Why WINS?
Treat-to-target (T2T) approach is now recognized in systemic lupus erythematosus (SLE), a highly complex autoimmune disease. The Lupus Low Disease Activity State (LLDAS) is a validated T2T endpoint in the management of SLE. Anifrolumab is a monoclonal antibody directed to the type I interferon (IFN) receptor. In the phase 3 TULIP trial anifrolumab treatment was associated with earlier, more frequent and more sustained attainment of LLDAS. These results highlight the potential utility of anifrolumab in a T2T paradigm for the management of SLE.
Interactive question
Would the use of targeted therapies accelerate the adoption of T2T in lupus? yes/no
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Jan 2023
" Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial "
Why WINS?
Remarkable data on novel treatment for systemic lupus erythematosus (SLE) has been recently presented. Deucravacitinib (DEUC) is an orally selective allosteric tyrosine kinase 2 (TYK2) inhibitor. Targeting TYK2 can interrupt signaling of type 1 interferons (IFNs), interleukin-10 (IL-10), IL-12 and IL-23. Deucravacitinib might be an effective and safe treatment option for lupus patients, according to a multicentre, phase 2, double-blind randomized trial. 363 adult patients with active SLE were enrolled. All study endpoints were met including SRI-4 at week 32 (primary study outcome). Phase 3 studies are now in progress and deucravacitinib could definitely be among the emerging therapeutics for SLE.
Interactive question
Is Deucravacitinib worth paying attention to?
Share your response with us using the hashtag #WhatIsNew and tag us @EMEUNET
December 2022
"Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial"
Why WINS?
Proliferative lupus nephritis (LN) can lead to renal failure. In patients with LN, after the induction phase of immunosuppressive therapy (IST), maintenance IST aims to prevent LN relapses. The optimal duration of maintenance IST remains unknown. While current 2019 EULAR/ERA–EDTA recommendations and 2021 KDIGO guidelines are largely based on experts opinion, WIN-Lupus is the first randomised controlled trial testing different durations of IST in proliferative LN. Non-inferiority of maintenance IST discontinuation after 2‒3 years was not demonstrated and patients who discontinued IST had a higher risk of severe flares of lupus. However, the majority of patients who discontinued IST did not experience a flare. Results from the WIN-Lupus study add a significant knowledge regarding the role of histological reassessment in identifying patients who can be safely weaned off maintenance IST.
Interactive question
What are the challenges of identifying patients who can be safely weaned from IST?
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November 2022
" Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports "
Why WINS?
The data on the use of belimumab in pregnancy and any associated risk of birth defects and pregnancy loss is very limited. This study provides information about birth defects and pregnancy losses among women exposed to belimumab during pregnancy. Overall, among pregnancies ending in live birth, the numbers of birth defects in belimumab exposed pregnancies were 5.6% in clinical trials, 21.7%, ad hoc 95% CI 9.8% to 33.7% and 0% in the BPR prospective and retrospective cohorts, respectively , and 1.1% in the postmarketing/spontaneous reports, with no consistent pattern of malformations. The numbers of pregnancy losses 31.8% in clinical trials, 4.2%, ad hoc 95%CI 0.0 to 9.8% and 50.0% in the BPR prospective and retrospective cohorts, respectively, and 31.4% in the postmarketing/spontaneous reports.
Interactive question
Do you have any cases of exposure to belimumab during pregnancy?
yes / no
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October 2022
" Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus "
Why WINS?
This study evaluates the efficacy of anti-CD19 compassionate-use chimeric antigen receptor (CAR) T cell therapy in 5 patients with SLE refractory to several immunosuppressive drugs with a median SLEDAI of 16. CAR T cells led to improvement of clinical symptoms and laboratory parameters including seroconversion of anti-double-stranded DNA antibodies. All 5 patients achieved remission of SLE according to DORIS criteria after 3 months and the median SLEDAI score after 3 months was 0. Drug-free remission was maintained during longer follow-up median of 8 months after CAR T cell administration. These data suggest that CD19 CAR T cell transfer is highly effective in SLE and provides new therapeutic possibilities to control SLE disease activity using autologous cells however,.
Interactive question
Do you think anti-CD19 CAR-T cell therapy will be a game-changing treatment for SLE patients?
yes / no
Share your response with us using the hashtag #WhatIsNew and tag us @EMEUNET
Sep 2022
"Interleukin-13 Receptor α1-Mediated Signaling Regulates Age-Associated/Autoimmune B Cell Expansion and Lupus Pathogenesis"
Why WINS?
IL-13 receptor α1 (IL-13Rα1) which is an X-linked receptor that transmits IL-4/IL-13 signals, is seemed affecting regulation of Age-associated/autoimmune B cells (ABCs) through interleukin-21 (IL- 21) signaling and its interplay with interferon-γ and IL-4. Human research may be conducted on this pathway to investigate sex differeneces in SLE and the data can translate into a potential target for new drug discoveries in the future.
Interactive question
Can IL-13Rα1 and related signaling pathway be one of the factors to explain sex differences in SLE? Furthermore, can it be a potential target for SLE through ABCs?
yes / no
Share your response with us using the hashtag #WhatIsNew and tag us @EMEUNET
