Op0149 Discordance in Clinical Response and Patient-Reported Outcomes in Moderate-Severe Sle: Results From the British Isles Lupus Assessment Group-Biologics Register (Bilag-Br)

Background: Rates of clinical response to medical therapies may be suboptimal in patients with SLE, and furthermore such responses may be discordant with patient reported outcomes. Objectives: To compare the proportion of active SLE patients with a response to therapy at 12 months using clinician assessment and patient reported outcomes. To investigate discordant outcomes between health-related quality of life (HR-QoL) and clinical response of patients with moderate-severe SLE in the UK. Methods: Patients with active disease (1xBILAG A or 2xBILAG B) commencing rituximab (RTX), belimumab or a standard of care medication (SoC) for SLE in the BILAG-BR were analysed over 12 months. Major clinical response (MCR) was defined as no BILAG-A or BILAG-Bs at follow-up, SLEDAI-2K ≤4 and prednisolone ≤7.5mg daily. Significant improvement (SI) was defined as ≤1 BILAG-B at follow-up, reduction in SLEDAI-2K and reduced daily prednisolone (less than baseline dose, ≤10mg daily if baseline dose 10-20mg, and ≤15mg if baseline dose ≥20mg). Data from the short form-36 (SF-36) were used to calculate mental (MCS) and physical component scores (PCS). Minimum clinically important difference in MCS and PCS was defined as 2.5. In patients with a SI, discordance between PCS and MCS was assessed using multivariate logistic regression. Missing data were imputed using random forest in R V4.2.2 (package: missForest V.1.5). Results: 782 patients with SLE (Female=705 90.2%, median age IQR: 39.7 31.0-49.7 years; RTX=595, belimumab=95, SOC=92) with active SLE and sufficient follow up data were recruited between 2010-2022. Ancestry was 443 (56.7%) White, 128 (16.4%) Black, 97 (12.4%) South Asian and 37 (4.7%) Chinese/ East Asian. 679 (86.8%) patients were taking prednisolone at baseline (median dose IQR: 8 5-12 mg daily). At 12 months, MCR was achieved in 106 (13.6%), and a further 279 (35.7%) demonstrated SI. Patients with SI at 12 months showed greater mean (SD) improvements their MCS (3.2 8.5 vs 1.3 8.4, p=0.0016) and PCS (6.1 7.5 vs 3.3 6.0, p), compared to those without SI. Of those who achieved SI, MCS improved in 235 (56.5%) and PCS in 311 (74.8%). The association of clinical factors with discordance of disease activity with MCS and PCS measures are described in Table 1. Discordant MCS was associated with lower baseline SLEDAI-2K score, East-Asian ancestral background, higher baseline SLICC-damage index and higher socio-economic deprivation. Discordant PCS was associated with lower baseline steroid dose, and belimumab therapy. Conclusion: We found significant discordance between clinical response and change in HR-QoL in this moderate severe SLE population. Almost half of patients achieving SI fail to demonstrate a clinically significant improvement in their psychological wellbeing. Several factors may help identify patients with discordant outcomes and could be targeted to support more holistic care for patients with SLE. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: Sarah Dyball Novartis, UCB, Mia Rodziewicz UCB, Emily Sutton: None declared, Ben Parker Eli Lilly, Roche, Fresenius-Kabi, AbbVie, Genzyme/Sanofi, GSK, Ian N. Bruce AstraZeneca, GSK, UCB, AstraZeneca, Eli Lilly, GSK, Merck Serono, UCB, ILTOO, Genzyme/Sanofi, GSK, Roche, UCB, Novartis.