Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus

The aim – evaluation of the efficacy and safety of anifrolumab (AFM) therapy in patients with severe and moderate systemic lupus erythematosus (SLE) in real clinical practice.

Material and methods. A prospective observational study (6 months) involving 14 patients with SLE (13 women and 1 man; mean age 37.5±14 years) treated in the rheumatology department of the Research Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. Ochapovsky. All patients included in the study were prescribed anifrolumab (Safnelo) 300 mg parenterally once every 4 weeks.

Results. Already after 3 months, regression of skin rashes was noted in all patients according to the CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) 10.0 [4.0; 11.0] vs 2.0 [2.0; 4.0] (p=0.013). Against the background of AFM therapy, relief of articular syndrome was noted in 90% of patients in the form of a decrease in the number of painful joints 1.5 (0.0; 10.0) vs 0.5 (0.0; 4.0) (p=0.041). Three months after the start of AFM therapy, a decrease in the SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000) activity index was registered in all patients. Its median decreased from 8.0 [6.0; 8.0] to 5.0 [4.0; 7.0] (p=0.007), and after 6 months – to 2.0 [0.0; 6.0] (p=0.005). Six months after the initiation of AFM therapy, 2 (16%) patients managed to achieve a decrease in SLEDAI-2K to 0, which corresponds to the indicators of clinical and laboratory remission of SLE. The criteria for low LLDAS (Lupus Low Disease Activity State) activity after 6 months of therapy were met by 8 (66%) out of 12 patients. Against the background of AFM therapy, positive dynamics of immunological activity was noted after 3 months – a decrease in the level of anti-dsDNA by 37%, the titer of ANF by 33%. Positive dynamics of hematological syndrome was observed against the background of AFM therapy. By the 3rd month of therapy, the proportion of patients with leukopenia less than 4×10⁹/l decreased from 21% to 0%, with lymphopenia less than 1×10⁹/l from 21% to 16%, with thrombocytopenia less than 100×10⁹/l from 8% to 0%, with hemolytic anemia from 8% to 0%. According to the LupusQol questionnaire, which assesses the quality of life associated with the disease, positive dynamics were recorded on all scales 6 months after the start of AFM treatment. Addition of AFM to standard therapy allowed to reduce the dose of glucocorticosteroids by 33% after 3 months from initiation and by 50% after 6 months.

Conclusions. Anifrolumab is a highly effective drug for the treatment of patients with severe and moderate systemic lupus erythematosus, has a favorable tolerability and safety profile.

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