Bristol Myers Squibb announced positive results from the Phase 3b/4 Psoriatyk Scalp study evaluating deucravacitinib in the treatment of patients with moderate to severe scalp psoriasisincluding those with less extensive psoriasis.
The primary endpoint – reports a note – was achieved, with a statistically significant improvement in the scalp-specific Physician’s Global Assessment (ss-Pga) of 0 or 1 (clear/almost clear) at 16 weeks, with a number of patients achieved three times greater ss-Pga 0/1 with deucravacitinib treatment compared to those treated with placebo (48.5% vs. 13.7%). The new Psoriatyk Scalp efficacy and safety results, patient-reported outcomes, and 23 other abstracts were presented at the European Academy of Dermatology and Venereology (Eadv) Congress in Amsterdam, which took place September 25-28.
“Approximately 80% of patients with plaque psoriasis have scalp involvement and typically experience itching, flaking, pain and bleeding, which significantly reduce their quality of life,” says Mark Lebwohl, dean of Therapeutic Clinic at Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai – These new findings confirm that deucravacitinib is a safe and effective once-daily oral treatment for people with moderate to severe psoriasis involving high impact areas such as the scalp.”
Additionally, the 52-week, multicenter, randomized, double-blind, placebo-controlled Phase 3b/4 study met key secondary endpoints at week 16, with a significantly higher proportion of patients achieving at least one 90% improvement in Psoriasis Scalp Severity Index (Pssi) response and change from baseline (Cfb) in scalp pruritus with deucravacitinib treatment compared to placebo. Greater improvements were reported by patients receiving deucravacitinib compared to placebo, respectively, in achieving minimal clinically important difference (MCID) for specific scalp pruritus (41.7% versus 9.8%), pain (26.2%) % vs 11.8%) and scaling (53.4% vs 19.6%), as well as for numeric rating scale (NRS) scores for whole body itching (39.8% vs 13.7% ).
The safety profile of deucravacitinib in the Psoriatyk Scalp study was consistent with those previously reported from clinical trials of deucravacitinib in psoriasis, the statement continues. The most common adverse events associated with deucravacitinib treatment in the study were nasopharyngitis (14.6%), upper respiratory tract infection (11.7%), acne (9.7%), migraine (7.8%), Covid-19 (5 .8%) and pustular acne (5.8%).
An interim analysis of the Registry of Psoriasis Health Outcomes: a Longitudinal Real-World Collaboration Study (RePhlect) evaluated 118 patients, 108 of whom had moderate to severe plaque psoriasis. The analysis demonstrated that the 6-month efficacy of continuous deucravacitinib treatment of patients from the real-world registry was consistent with the efficacy results observed in the Poetyk Pso clinical trials in patients with moderate to severe plaque psoriasis. The results show that patients in the overall group achieved a statistically significant mean reduction in disease severity measures (67.9% achieved a Psoriasis Area and Severity Index or Pasi score ≤3; mean baseline Pasi score 6.3 , change from baseline -4.1), the percentage of body surface area (Bsa) affected score (64.1% of patients achieved a Bsa ≤3%; mean score at baseline 9.3, change from baseline -5, 8) and Investigator’s Global Assessment or Iga score (46.8% achieved an Iga score of 0/1; mean baseline Iga score 2.7, change from baseline -1.2) from baseline to follow-up . Similar results were observed in the subgroup of patients with moderate to severe plaque psoriasis.
“These data further demonstrate the safety and efficacy of deucravacitinib in the treatment of psoriasis in high-impact areas, such as the scalp – highlights Daniel Quirk, Senior Vice President, Worldwide Immunology and Neuroscience medical affairs, Bristol Myers Squibb – and includes the first analysis from our RePhlect registry, providing evidence highlighting the benefit in a real-world setting of deucravacitinib in the treatment of moderate to severe plaque psoriasis. We believe that deucravacitinib has the potential to be a systemic therapy that clinicians can rely on treatment of adult patients with moderate to severe plaque psoriasis, especially with scalp involvement. Overall, these promising results support once-daily deucravacitinib as a potential standard of care as we continue to drive Tyk2 innovation.”
Psoriasis is a chronic, immune-mediated, widely spread systemic disease that significantly compromises patients’ health, quality of life and productivity in the workplace. It represents a serious global problem, with at least 100 million people worldwide affected by some form of this disease, including approximately 14 million in Europe and 7.5 million in the United States. About a quarter of patients with psoriasis have the moderate-severe form. Up to 90% of patients with psoriasis have the vulgar form, or plaque psoriasis, characterized by distinct oval or round plaques typically covered with whitish scales. Although effective systemic therapies are available, many patients with moderate to severe psoriasis are undertreated or treated adequately and are dissatisfied with current therapies.
Psoriasis is associated with several comorbidities that affect patients’ well-being, such as psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, and depression. Scalp psoriasis, which occurs in approximately 80% of patients with plaque psoriasis, is associated with itching, scaling, pain, and bleeding and significantly affects health-related quality of life. Scalp psoriasis can be difficult to treat with topical agents, and there is limited data available on the effectiveness of systemic agents in treating moderate to severe scalp disease.
Deucravacitinib is also the subject of clinical trials in multiple immune-mediated diseases.
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