Long-Term Anifrolumab Treatment Normalizes Hematologic Parameters and Several Serologic Markers in Patients With Systemic Lupus Erythematosus

Objective To evaluate the long-term effects of anifrolumab on hematologic and serologic parameters over four years.Methods This analysis included 536 patients with moderate-to-severe systemic lupus erythematosus (SLE) who received intravenous anifrolumab 300 mg (n = 358) or placebo (n = 178) in the 52-week, phase 3 TULIP-1/2 trials (NCT02446912 and NCT02446899) and continued the same treatment in the 3-year, long-term extension (LTE, NCT02794285), or would have done if not discontinued early; 369 patients entered the LTE. Changes from baseline to week 208 in lymphocytes, hemoglobin, platelets, neutrophils, complement C3, C4, anti-double-stranded DNA (dsDNA), and Igs were analyzed descriptively. British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52 was analyzed by treatment and lymphocyte, hemoglobin, and platelet normalization in responders versus nonresponders, regardless of treatment.Results Numerically greater improvements from baseline in lymphocyte, hemoglobin, platelet, and neutrophil levels were observed with anifrolumab over placebo. Comparing anifrolumab versus placebo, lymphocyte and hemoglobin normalization rates were higher and platelet normalization was comparable. BICLA response was associated with lymphocyte, hemoglobin, and platelet normalization over four years, regardless of treatment. Conversely, BICLA responses were higher with anifrolumab versus placebo, irrespective of baseline lymphocyte, hemoglobin, and platelet levels. Improvements in anti-dsDNA, C3, C4, and Igs from baseline were greater with anifrolumab versus placebo.Conclusion The normalization of hematologic parameters and sustained improvements in serologic markers support the long-term efficacy of anifrolumab in patients with moderate-to-severe SLE. Clinical response to anifrolumab was associated with improvements in biomarkers, suggesting restoration of overall immune health.