Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial
Por:
Thaci, D, Strober, B, Gordon, KB, Foley, P, Gooderham, M, Morita, A, Papp, KA, Puig, L, Menter, MA, Colombo, MJ, Elbez, Y, Kisa, RM, Ye, JN, Napoli, AA, Wei, L, Banerjee, S, Merola, JF, Gottlieb, AB
Publicada:
1 feb 2022
Ahead of Print:
1 ene 2022
Resumen:
Introduction Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. Methods Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. Results Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient's life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. Conclusion Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition.
Plain Language Summary Psoriasis is a skin disease that affects up to 2% of the population. In psoriasis, red, scaly lesions develop on the skin driven by an aberrant immune response. Psoriasis impacts not only physical and mental health but also quality of life (QoL). Deucravacitinib is being investigated as a treatment for psoriasis. We performed a Phase 2 dose-ranging, placebo-controlled, 12-week study of deucravacitinib in adults with moderate to severe psoriasis. Patients in the USA, Australia, Canada, Germany, Japan, Latvia, Mexico, and Poland participated. The study showed that oral treatment with deucravacitinib was effective using a disease severity score (percentage of patients with >= 75% reduction from baseline in Psoriasis Area and Severity Index score) at Week 12-placebo 7% and deucravacitinib 67%-75% for the three highest dosages-and was generally well tolerated. We further analyzed the association between efficacy and a QoL measure, the Dermatology Life Quality Index (DLQI), in patients who received placebo or the most effective dosages of deucravacitinib (>= 3 mg twice daily). Deucravacitinib was effective at the three dosage levels tested. Skin improvement occurred early during treatment and was mirrored by improvements in DLQI score during the 12 weeks of treatment. Although some patients did not have complete clearance of their psoriasis, a large percentage of those patients still achieved considerable improvement in QoL as measured by achieving a DLQI score of 0/1 (i.e., no effect at all on the patient's QoL).
Filiaciones:
Thaci, D:
Univ Lubeck, Inst & Comprehens Ctr Inflammat Med, Ratzeburger Allee 160, D-23538 Lubeck, Germany
Strober, B:
Yale Univ, Cent Connecticut Dermatol Res, New Haven, CT USA
Gordon, KB:
Med Coll Wisconsin, Milwaukee, WI 53226 USA
Foley, P:
Univ Melbourne, Skin Hlth Inst, Prob Med Res, St Vincents Hosp Melbourne, Melbourne, Vic, Australia
Gooderham, M:
Queens Univ & Prob Med Res, SKiN Ctr Dermatol, Peterborough, ON, Canada
Morita, A:
Nagoya City Univ, Grad Sch Med Sci, Nagoya, Aichi, Japan
Papp, KA:
Clin Res & Prob Med Res, Waterloo, ON, Canada
Puig, L:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona, Spain
Menter, MA:
Baylor Univ, Med Ctr, Dallas, TX USA
Colombo, MJ:
Bristol Myers Squibb, Princeton, NJ USA
Elbez, Y:
Bristol Myers Squibb, Princeton, NJ USA
Kisa, RM:
Bristol Myers Squibb, Princeton, NJ USA
Ye, JN:
Bristol Myers Squibb, Princeton, NJ USA
Napoli, AA:
Bristol Myers Squibb, Princeton, NJ USA
Wei, L:
Bristol Myers Squibb, Princeton, NJ USA
Banerjee, S:
Bristol Myers Squibb, Princeton, NJ USA
Merola, JF:
Harvard Med Sch, Brigham & Womens Hosp, Boston, MA 02115 USA
Gottlieb, AB:
Icahn Sch Med Mt Sinai, New York, NY 10029 USA
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