Understanding Psoriasis Clinical Trials Landscape in India with Special Focus on Biologics

Abstract

Psoriasis is a non-communicable disease characterized by inflammation involving cutaneous T cells, dendritic cells, and keratinocytes. Release of cytokines leads to keratinocyte hyperproliferation and scaly plaques, and other manifestations of the disease including psoriatic arthritis, cardiovascular disease, and metabolic syndrome. Emollients; topical therapy with corticosteroids, vitamin D and vitamin D analogues, tar preparations, and dithranol; and phototherapy may help in mild to moderate disease, but as the disease worsens, methotrexate, ciclosporin, acitretin, apremilast (phosphodiesterase 4 inhibitor), biologics, and oral Janus Kinase or JAK inhibitors may be needed. Biologics include monoclonal antibodies that block cytokines or cytokine receptors are indicated in moderate to severe psoriasis. Several biologics are available, including tumor necrosis factor (TNF) inhibitors etanercept, adalimumab, infliximab, and certolizumab; interleukin 12/interleukin 23 inhibitor ustekinumab; interleukin 17 inhibitor secukinumab, ixekizumab and brodalumab; and interleukin 23 inhibitor guselkumab and tildrakizumab. Psoriasis disease has been a focus of clinical research worldwide, and India has also taken active part in clinical research in this area. Clinical trial registry of India shows that both indigenous medicines and allopathy drugs have been tested in clinical trials in India, including biologics such as adalimumab, etanercept, secukinumab, golimumab, ixekizumab, and ustekinumab. In this paper we wish to discuss the evolving landscape of psoriasis clinical trials in India, the evaluation and monitoring measures used, the number of psoriasis patients in India, and the average number of psoriasis patients seen in Indian dermatology clinics.