The US Food and Drug Administration has approved deucravacitinib (Sotyktu) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, according to a statement from Bristol Myers Squibb.
Announced on September 9, approval of the first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor is based on the results of the phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which compared deucravacitinib against placebo therapy and twice-daily apremilast in more than 1600 adult patients with moderate-to-severe plaque psoriasis.
“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California, in the aforementioned statement. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”
With large amounts of anticipation surrounding its potential approval and availability expected in September 2022, excitement surrounding deucravacitinib has reached a fever pitch in the dermatology community, not just for its potential in plaque psoriasis but in other conditions as well. Currently, deucravacitinib is also being examined in phase 1 or phase 2 trials for use as a treatment of other conditions, including psoriatic arthritis, systemic lupus erythematosus, and ulcerative colitis.
Both the pivotal POETYK PSO-1 and POETYK PSO-2 trials were multicenter, randomized, double-blind, placebo- and active comparator-controlled trials. With 664 and 1020 patients enrolled in POETYK PSO-1 and POETYK PSO-2, investigators had information related to more 1684 adult patients with moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy.
In the trials, use of deucravacitinib provided superior efficacy compared to placebo and apremilast at both 16 and 24 weeks, with responses persisting through 52 weeks. At week 16 of the POETYK PSO trials, the most common adverse reactions in patients on deucravacitinib were upper respiratory infections (19.2%), blood creatine phosphokinase increase (2.7%), herpes simplex (2.0%), mouth ulcers (1.9%), folliculitis (1.7%) and acne (1.4%).
“The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments. This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis,” said Samit Hirawat, MD, Chief Medical Officer, Bristol Myers Squibb. “We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases.”
In their release, Bristol Myers Squibb pointed out deucravacitinib is not recommended for use in combination with other potent immunosuppressants and is contraindicated in those with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in deucravacitinib.
The announcement of the approval came just hours before a September 10 presentation of the 2-year results from the POETYK PSO long-term extension (LTE) trial, which assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial. In the trial, use of deucravacitinib was associated with modified non-responder imputation (mNRI) response rates of 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90, and 66.5% for static Physician's Global Assessment 0/1 at 112 weeks.
“The reality we are facing is that dermatologists and individuals with psoriasis alike have identified the need for more effective and tolerable oral therapies, as psoriasis is a chronic, systemic, immune-mediated disease that is associated with serious comorbidities,” said Dr. Mark Lebwohl, MD, Dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine, Mount Sinai (New York), who was also a participant in the Publication Steering Committee for the long-term extension study, in the September 10 release from Bristol Myers Squibb. “These new long-term results showing durable efficacy through up to two years of continuous treatment further support the use of once-daily Sotyktu for people with moderate-to-severe plaque psoriasis and address the need for more effective oral treatment options.”