Background and Objectives: Biological therapy is widely used for the treatment of severe psoriasis. The objective of this study was to evaluate the efficacy and safety of biological therapy for patients with severe psoriasis. Materials and Methods: A retrospective study of 79 patients with severe psoriasis, who have been treated with biological therapy between 2012 and 2018, was conducted. During this study, the following data were collected and evaluated: sex, age, body mass index (BMI), duration of illness, the results of treatment with biological therapy, concomitant therapy, Psoriasis Area and Severity Index (PASI) and adverse events. Results: In total, 74.7% (n = 59) of subjects were male. Their overall average age was 47.4 ± 11.4 (range: 18-73) years. Their baseline BMI was 27.6 ± 5.9, which increased to 29.6 ± 4.5 after 6 years of treatment. The mean duration of psoriasis was 25.7 ± 12.5 years. In total, 39.2% (n = 31) of subjects received infliximab, 36.7% (n = 29)-etanercept, 24.1% (n = 19)-ustekinumab. The treatment duration for infliximab, etanercept and ustekinumab was 201.6 ± 86.8, 156.2 ± 137.4 and 219.1 ± 95.7 weeks (p < 0.01), respectively. Overall, 65.8% (n = 52) of subjects were also on methotrexate; 30.8% (n = 16) of them discontinued it due to clinical improvement (31.3% (n = 5)), impaired liver function (31.3% (n = 5)), and intolerance (25% (n = 4)). Baseline PASI was 20.8 ± 8.8. PASI 50 was achieved by 96.2% (n = 76) of patients at week 11, PASI 75 by 86.1% (n = 68) at week 16, PASI 90 by 54.4% (n = 43) at week 35, and PASI 100 by 13.9% (n = 11) at week 33. The overall incidence rate of adverse events was 0.362 per patient year of follow-up. Conclusion: Biological therapy is an effective and safe treatment for patients with severe psoriasis.
Keywords: PASI; biological therapy; efficacy; safety; severe psoriasis.