Randomized study of the efficacy of monoclonal antibodies in patients with refractory psoriasis

BACKGROUND: The main vector of psoriasis therapy is suppression of proliferative activity of keratinocytes, normalization of their differentiation, neutralization of immune inflammation in the dermis and normalization of cytokine balance.

AIM: of the study was to study the efficacy and tolerability of an IL-17A inhibitor (secukinumab) as monotherapy and in combination with methotrexate in patients with moderate and severe psoriasis vulgaris.

MATERIALS AND METHODS: The severity of psoriasis was assessed by the Psoriasis Prevalence and Severity Index (Psoriasis Area and Severity Index, PASI). To assess the damage to the nail plates of the hands and feet in psoriasis, the NAPSI index (Nail Psoriasis Severity Index) was used. In order to assess the quality of life of patients with psoriasis, a Russian-language version of the dermatological quality of life index (DQLI) was used. Patients' quality of life was assessed before the prescribed therapy and at 12 weeks of treatment. Assessment of the severity of itching and its impact on the daily life of patients was carried out according to the Prurindex questionnaire.

RESULTS: All patients were divided into two groups by a randomized method. The first group included 25 patients who received therapy with secukinumab in the age category of 55 (30–67) years. The second group included 25 patients aged 56 (34–69) years of moderate and severe psoriasis who were treated with secukinumab after initiation (300 mg) 150 mg subcutaneously in combination with methotrexate 15 mg intramuscularly for 24 weeks. Thus, in the first group PASI 90 was achieved after 24 weeks ― in 69%, PASI 100 ― in 31% patients; in the second group ― PASI 90 ― in 68%, PASI 100 ― in 32% patients respectively. In both groups, it was possible to maintain clinical remission (PASI ≥90) in 87.3% of patients throughout the year. During therapy in patients of both groups, there was a decrease in DLQI values from 25.6±3.7 to 3.5±3.1 (p <0.01) in the first group and from 23.3±3.7 up to 3.1±2.6 in the second group.

CONCLUSIONS: Treatment of patients with moderate and severe psoriasis vulgaris with secukinumab has shown its high efficacy and safety. Moreover, it was estimated that the combination of secukinumab and methotrexate is comparable in effectiveness to secukinumab monotherapy. It has been established that the use of secukinumab as monotherapy and in combination with methotrexate significantly improves the quality of life of patients with moderate and severe psoriasis vulgaris.