Introduction:

Psoriasis, systemic inflammatory skin disease, has serious adverse consequences for the physical, mental and social well-being of people; its treatments are expensive and with marked adverse effects. Itolizumab, a humanized anti-CD6 monoclonal antibody, acts as an immunomodulator of T cells and plays an important role in its pathogenesis.

Objective:

To evaluate the efficacy and clinical safety of itolizumab in 80 patients with severe psoriasis vulgaris.

Methods:

An expanded clinical use program was carried out, promoted by the Molecular Immunology Center. The clinical response was measured by the severity index and area of psoriasis involvement and for effectiveness these elements were combined with safety, through a complementary clinical analysis of the data generated during the induction phase. Absolute numbers, percent and average and association statistics such as Pearson's correlation tests or Lambda's test were used as summary measures.

Results:

The area of psoriasis involvement analysis showed a rapid and sustained decrease in its values; adverse events related to the administration of the product under investigation prevailed, light onset, very probable and not serious.

Conclusions:

Itolizumab is safe and effective in 96% of severe psoriatic patients during the induction phase.

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