In patients with moderate to severe systemic lupus erythematosus (SLE), improvements in disease activity, health-related quality of life (QOL), fatigue, and pain were reported with anifrolumab, according to study results published in Lancet Rheumatology.
Researchers sought to evaluate the clinical meaningfulness of a British Isles Assessment Group-based Composite Lupus Assessment (BICLA) response by using patient-reported outcomes collected from BICLA responders vs nonresponders among patients with moderate to severe SLE.
A post-hoc analysis of the phase 3 TULIP-1 (ClinicalTrials.gov Identifier: NCT02446912) and TULIP-2 (ClinicalTrials.gov Identifier: NCT02446899) studies was conducted.
Patients with moderate to severe SLE were randomly assigned to receive anifrolumab 300 mg or placebo intravenously once every 4 weeks for a total of 48 weeks. All participants were aged between 18 and 70 years and met the American College of Rheumatology (ACR) classification criteria for SLE.
A total of 726 patients were enrolled in the TULIP studies, 366 of whom were in the placebo group (n=184 in TULIP-1 and n=182 in TULIP-2) and 360 of whom were in the anifrolumab group (n=180 in TULIP-1 and n=180 in TULIP-2). The mean participant age was 41.8±11.9 years; 93% of the patients were women and 66% were White. Overall, 39% of the participants were BICLA responders and 61% were BICLA nonresponders.
The BICLA responders vs nonresponders reported greater mean improvements from baseline at week 52 in Patient Global Assessment (PGA), Short Form 36 Health Survey (SF-36), Lupus Quality of Life, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and pain Numerical Rating Scale scores (nominal P <.0053 for all).
Compared with BICLA nonresponders, a greater percentage of BICLA responders reported improvements that were greater than or equal to the minimum clinically important difference across all SF-36 domains: Physical Component Summary (15% vs 60%, respectively), Mental Component Summary (15% vs 51%, respectively), and Role Physical (19% vs 70%, respectively); Lupus Quality of Life domains: physical health (15% vs 58%, respectively) and intimate relationships (11% vs 41%, respectively); and with regard to FACIT-F (15% vs 56%, respectively).
A greater percentage of BICLA responders vs nonresponders also had scores that were equal to or greater than normative values across all SF-36 domains and FACIT-F at week 52. Further, patients who received treatment with anifrolumab vs placebo reported greater numerical improvements in PGA, SF-36, Lupus Quality of Life, FACIT-F, and pain Numerical Rating Scales scores.
Study limitations included that the interpretation of the results was by the post-hoc nature of the analysis, and in the BICLA responder analyses, the groups were compared based on postrandomization characteristics, which may have been associated with an imbalance in baseline characteristics and stratification factors.
The researchers concluded, “These results support the importance of the BICLA response definition in terms of patients’ experiences and impacts of their disease, as well as for other clinical responses, such as sustained oral glucocorticoid tapering, fewer flares, and less medical resource [utilization].”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Strand V, O’Quinn S, Furie RA, et al. Clinical meaningfulness of a British Isles Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab. Lancet Rheumatol. 2022;4(3):e198-e207. doi:10.1016/S2665-9913(21)00387-8