PO:16:225 | Belimumab in refractory and/or non-criteria manifestations of antiphospholipid syndrome: ad interim analysis on Quality-of-Life changes from the BLAST trial

Alessio Conti¹, Lois Ira Capulong¹, Irene Cecchi¹, Elena Rubini¹, Chiara Bova¹, Massimo Radin¹, Alice Barinotti¹, Beatrice Ala¹, Silvia Grazietta Foddai¹, Daniela Rossi¹, Roberta Fenoglio¹, Savino Sciascia¹ | ¹Centro di Eccellenza Universitario per le Malattie Nefrologiche, Reumatologiche e Rare, S.G.Bosco -ASL Città di Torino, Italy

Objectives The Belimumab Antiphospholipid Syndrome Trial (BLAST) is a prospective study designed to assess the safety and tolerability of belimumab over 24 months in patients persistently positive for aPL, as well as its impact on patients' Quality of Life (QoL). This preliminary analysis aims to provide early evidence of improvements in subjective well-being and QoL in patients enrolled in BLAST.

Materials and Methods. In this ad interim analysis, we analyzed the first 14 patients who completed a set of structured questionnaires related to disease activity, fatigue, illness perception, and pain at baseline and after 20 weeks of treatment through Fatigue Severity Scale (FSS), Short Form-36 (SF-36), and Numeric Rating Scale (NRS). FSS included 9 statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue. SF-36 questions were grouped into eight domains: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), emotional well-being (5 items), while the last item pertains to the overall health change. NRS assessed patients' subjective perceptions of their disease activity, pain, and general illness, on a scale from 0 (none) to 10 (worst imaginable).

Results. At week 20, most patients reported a statistically significant improvement regarding their health change status, with scores more than doubling (an increase of 105.6%) compared to baseline. SF-36 scores generally reflected positive outcomes across most domains. Improvements were most frequently observed in general health (23.5%), pain (31%), and vitality (8.2%). Physical functioning (11.8%) and role limitations (both physical, 20.7% and emotional, 25%) showed modest improvements or remained stable. Emotional well-being (5.9%) and social functioning (6.4%) yielded mixed results Percentages reflect the degree of improvement relative to baseline. When referring to fatigue, the results were heterogeneous; seven patients reported increased fatigue, five reported decreased fatigue, one remained unchanged, and one questionnaire was incomplete (results are summarised in Table 1 and the graphs below). According to the NRS, regarding disease activity, the majority of patients (n= 8) reported improvement, while three reported worsening and one reported no change. Pain outcomes were mixed: two patients experienced less pain, three reported increased pain, and seven showed no change in their pain levels. Perceptions of general illness also varied: six patients reported worsening, four reported improvement, and two reported no change. Two patients were classified as non-responders.

Conclusions. Given the inherent limitations of interim analyses, these preliminary findings are encouraging. Ongoing long-term follow-up will be essential to confirm the positive trends observed and to gain a deeper understanding of belimumab’s impact on subjective APS-related outcomes.