Real-World Effectiveness and Safety of Anifrolumab in Egyptian Patients with Moderate-to-Severe Systemic Lupus Erythematosus: A Retrospective Multicenter Study.

Background and

Objectives

Real-world data on anifrolumab in Egyptian patients with moderate-to-severe systemic lupus erythematosus (SLE) remain limited. This study aimed to evaluate the real-world effectiveness and safety of anifrolumab in Egyptian patients with moderate-to-severe SLE. Materials and

Methods

This retrospective, multicenter, observational cohort study reviewed the medical records of 80 adults with moderate-to-severe SLE who had received at least 6 doses (≥20 weeks) of intravenous anifrolumab 300 mg every 4 weeks as part of routine clinical care at 13 Egyptian tertiary rheumatology centers; medical record review and data extraction were performed between May and July 2026. Outcomes were assessed at baseline and final follow-up and included disease activity, lupus low disease activity state (LLDAS), glucocorticoid use, flare status, laboratory parameters, and adverse events.

Results

Patients were predominantly female (98.8%), with a mean age of 30.4 ± 9.8 years. Disease activity improved, with SLEDAI-2K decreasing from 11 to 4 (p < 0.001), PGA from 2.7 to 0.5 (p < 0.001), LLDAS increasing from 0% to 51.3% (p < 0.001), and flares decreasing from 95.0% to 18.8% (p < 0.001). Glucocorticoid burden also declined, with oral glucocorticoid use falling from 95.0% to 83.8% (p = 0.021), median prednisone dose from 20 mg/day to 5 mg/day (p < 0.001), intravenous methylprednisolone use from 50.0% to 6.3% (p < 0.001), and 63.8% achieving prednisone doses ≤ 7.5 mg/day (p < 0.001). Laboratory improvement included hemoglobin, leukocyte count, lymphocyte count, platelet count, C3, C4, anti-dsDNA, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), while serum creatinine did not change significantly (p = 0.904). No serious adverse events were reported.

Conclusions

Anifrolumab was associated with significant short-term improvement in clinical and laboratory disease activity, marked steroid sparing, and reduced flare burden in Egyptian patients with moderate-to-severe SLE, with acceptable short-term tolerability.