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The new data on this drug’s effects on maintenance of clinical response indicates the strength of the treatment for individuals with the immune-mediated skin disease.
Clinical response rates of individuals with moderate-to-severe plaque psoriasis treated with deucravacitinib (Sotyktu) may remain stable with 3 years of continuous treatment, according to new data from Bristol Myers Squibb presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin.1
The new findings resulted from a 3-year extension study—the POETYK PSO long-term extension (LTE) trial—assessing deucravacitinib treatment for adult subjects with plaque psoriasis. The new extension trial was preceded by the 2 global phase 3 studies titled POETYK PSO-1 and POETYK PSO-2.
“These new, positive, three-year results reinforce the long-term efficacy and well-established safety profile of once-daily Sotyktu, the first and only TYK2 inhibitor available, and add to our confidence in its role as an oral treatment of choice for adults with moderate-to-severe plaque psoriasis,” April Armstrong, MD, MPH, POETYK PSO clinical investigator and chief of dermatology at UCLA, said in a statement.
Both POETYK PSO-1 and POETYK PSO-2 were worldwide, phase 3 clinical trials which assessed the safety and the efficacy of deucravacitinib versus placebo and versus apremilast in those with moderate-to-severe cases of plaque psoriasis. The multicenter, randomized, double-blind studies involved 666 and 1,020 patients, respectively.
The studies compared 6 mg of deucravacitinib per-day to placebo and 30 mg of apremilast twice-per-day. The POETYK PSO-2 trial also included a randomized withdrawal and retreatment phase following the 24-week mark.
The investigators of both initial trials reported that significantly more deucravacitinib-treated subjects were able to achieve clear/almost clear skin, to achieve a Psoriasis Area and Severity Index (PASI)-75 response, and to achieve a PASI-90 response. These results were also largely maintained through to 52 weeks.
Following the completion of the 52-week trials, those involved had the chance to take part in the ongoing POETYK PSO LTE trial. In the extension study, 1,221 individuals were given open-label deucravacitinib with 6 mg per-day.
At the 148-week mark, the research team found that clinical response rates remained stable with participants’ continuous treatment, noting responses of 73.2% for PASI-75, 48.1% for PASI-90, and 54.1% for static Physician’s Global Assessment (sPGA) 0/1, as assessed through modified nonresponder imputation (mNRI).
The team added that deucravactinib was shown to have maintained a consistent safety profile and not to have any substantial increases in adverse events (AEs) or serious AEs over the course of the study, as well as no new safety concerns.
“For my patients, more days of relief from this chronic disease mean that they can focus on other aspects of their lives, and these POETYK PSO long-term data add to the evidence that we have the ability to offer a new standard of care to patients seeking an oral treatment option,” Armstrong noted in her statement.
In September of 2022, the US Food and Drug Administration (FDA) had approved deucravacitinib for the treatment of individuals with plaque psoriasis. The approval marked a major development in the systemic treatment landscape.2
The drug is an oral medication which is tailored to target tyrosine kinase 2 (TYK2) specifically, thereby obstructing the signaling of crucial cytokines, including interleukin(IL)-23, IL-12, and Type 1 interferons, known to play a major role in the development of several different immune-mediated disorders.