Dermatologists welcome new oral therapy for psoriasis

Pharma News: A first-in-class oral treatment for moderate-to-severe plaque psoriasis has been Therapeutics Goods Administration (TGA) registered.

When Bristol Myers Squibb acquired Celgene in 2019 for $74 billion, it opted to keep the dermatology and immunology drug Sotyktu (deucravacitinib), as opposed to Otezla.

Bristol Myers Squibb’s (BMS) registration of Sotyktu, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks.

“Australians living with moderate-to-severe plaque psoriasis face significant quality of life burdens. Sotyktu has the potential to become a new standard of care oral treatment for these patients,” said Associate Professor Peter Foley, Dermatologist and Director of Research, Skin Health Institute.

According to Associate Professor Foley, approval of new treatment options is meaningful given how widely prevalent psoriasis, particularly plaque psoriasis, is in Australia.

“The registration of Sotyktu is important for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional systemic treatments,” said Associate Professor Foley.

Dr Melinda Munns, Medical Director for BMS Australia and New Zealand said this TGA registration represents an important milestone in our commitment to immunology.

“BMS scientists designed Sotyktu to selectively target TYK2, a kinase involved in signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in psoriasis pathogenesis. We believe Sotyktu is a breakthrough treatment for patients with this condition. The potential use of Sotyktu in other immune-mediated diseases in the future is something we’re excited by,” said Dr Munns.

Psoriasis is a chronic, systemic immune-mediated disease that substantially impacts patients’ physical health, quality of life and work productivity. It affects approximately 1.6 million people in Australia. Up to 90 percent of patients with psoriasis have plaque psoriasis, which is characterised by distinct, round or oval plaques typically covered by silvery white scales.