Bristol Myers Squibb’s Deucravacitinib Impresses in Phase 3 Psoriasis Trial

By Daniel Ojeda, Ph.D.

On November 3rd, Bristol Myers Squibb reported results for Deucravacitinib in Phase 3 clinical trial in patients with moderate to severe plaque psoriasis. Treatment with Deucravacitinib resulted in more patients achieving 75 percent improvement in Psoriasis Area and Severity Index (PASI 75) and a static Physician’s Global Assessment (sPGA) score compared to placebo. Additionally, in patients that reached a PASI 75, Deucravacitinib was superior to Otezla.

Psoriasis is an immune-mediated skin disease that affects more than 8 million people in the US and over 125 million people worldwide. This disease is caused by the production of skin cells at a faster rate than normal, which in turn results in the appearance of red, itchy lesions most commonly in the lower back, knees, and elbows of patients. Currently, there is no cure for this chronic inflammatory disease.

Treatments for Psoriasis

Currently, treatments available to treat psoriasis focus on controlling the symptoms. The most commonly prescribed medication for psoriasis are corticosteroid ointments and creams. However, they are normally prescribed to treat mild to moderate disease versions. For the treatment of moderate to severe psoriasis, a growing number of antibody therapies include drugs such as Humira by AbbVie and Stelara, by Johnson & Johnson. One of the biggest drawbacks of these medications is the need to inject the medicine and the risk of severe infections.

Treatments for psoriasis that can be taken orally include methotrexate, which is less effective than injected medications and can lead to low immune cell count and liver damage. Otezla by Amgen is the only other orally available therapy to treat psoriasis. There is an unmet need for more orally available therapeutics with fewer side effects.

Deucravacitinib

Deucravacitinib (BMS-986165) is an orally available, selective inhibitor for the tyrosine kinase 2 (TYK2). The TKY2 protein is responsible for the induction of molecules crucial for inflammatory and immune responses. This drug’s efficacy is currently being evaluated in the POETYK PSO-1 clinical trial, which is a multicenter, randomized, double-blind, placebo- and active comparator-controlled trial.

The trial includes approximately 600 patients, and the full evaluation of the results is still underway. However, preliminary results show that Deucravacitinib treatment was more effective in reducing the psoriasis area by 75% or more and achieving an sPGA score of clear or almost clear when compared to placebo control. Additionally, at Week 16 of the study, more patients reached PSAI 75 and sPGA while taking Deucravacitinib than Otezla. However, more detailed information on the number of patients and the extent of the difference will be available in the first quarter of 2021.

Dr. Samit Hirawat, Executive Vice President, Chief Medical Officer, Global Drug Development, Bristol Myers Squibb, said, “We are encouraged by the efficacy and the safety profile observed in the POETYK PSO-1 study, which supports the strong potential we see for Deucravacitinib, our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis,” He added, “We recognize there is a significant unmet need for new therapeutic options for people with immune-mediated diseases, such as psoriasis, and are committed to pursuing potential new medicines that will give physicians additional choices to effectively treat and manage their patients.”

Related Article: Cosentyx Bags EU Approval for First-Line Treatment of Pediatric Psoriasis

References

1. https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Announces-Deucravacitinib-BMS-986165-Demonstrated-Superiority-to-Placebo-and-Otezla-apremilast-in-Pivotal-Phase-3-Psoriasis-Study/default.aspx
2. https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840
3. https://www.psoriasis.org/psoriasis-statistics/#:~:text=Prevalence&text=1%5D-,125%20million%20people%20worldwide%E2%80%942%20to%203%20percent%20of%20the,the%20World%20Psoriasis%20Day%20consortium.
4. https://www.psoriasis.org/oral-treatments/
5. https://clinicaltrials.gov/ct2/show/NCT03624127

Author

Daniel Ojeda