Photo Credit: TimoninaIryna
At the 2024 Winter Clinical Derm Conference, April W. Armstrong, MD, MPH, presented as part of the session “Clinical and Therapeutic Pearls in Psoriasis.”
At the 2024 Winter Clinical Dermatology Conference, held January 12-17, 2024 in Honolulu, April W. Armstrong, MD, MPH, presented as part of the session “Clinical and Therapeutic Pearls in Psoriasis.”
Dr. Armstrong published two papers recently that address this topic, which we summarize here:
Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary: A Secondary Analysis of a Randomized Clinical Trial
JAMA Dermatol. 2023, Dec 20. (Online ahead of print).
Significance: The change from baseline score on the Psoriasis Symptoms and Signs Diary (PSSD), a validated patient-reported measure, is commonly used in psoriasis clinical trials. However, there is a lack of established meaningful score change thresholds based on patient-reported assessments.
Objective: This study aims to determine meaningful within-patient score change thresholds for the PSSD using data from the POETYK PSO-1 clinical trial, a phase 3 Program to Evaluate the Efficacy and Safety of Deucravacitinib, a Selective TYK2 Inhibitor. This trial compared deucravacitinib, placebo, and apremilast in adults with moderate to severe plaque psoriasis.
Methods: In this predefined analysis of the multicenter, randomized, double-blind, placebo-controlled trial conducted from August 7, 2018, to September 2, 2020, 666 adults completed the PSSD daily. Meaningful change thresholds were established by relating the mean PSSD score change from baseline to week 16 to category improvements on the Patient Global Impression of Change (PGI-C) and the Patient Global Impression of Severity (PGI-S).
Results: The main outcome focused on the score change from baseline to week 16 on the PSSD, anchored to the PGI-C and PGI-S. Among 666 patients (mean [SD] age, 46.1 [13.4] years; 453 men [68.0%]), three thresholds were identified in an analysis set of 609 patients. A score improvement of at least 15 points from baseline indicated meaningful within-patient change based on the PGI-C. Improvements of 25 points were supported by both the PGI-C and the PGI-S, while a 30-point score change identified patients experiencing greater improvements in their psoriasis symptoms and signs.
Conclusion: This analysis suggests that PSSD score improvements of 15, 25, or 30 points represent incremental enhancements in disease burden that hold significance for patients with psoriasis.
Cost-Effectiveness of Tildrakizumab for the Treatment of Moderate-to-Severe Psoriasis in the United States
J Dermatolog Treat. 2022;33(2):740-748.
Objective: To assess the cost-effectiveness of tildrakizumab compared to other biologic and targeted systemic treatments, as well as a combination of topical therapies, phototherapies, and other conventional systemic therapies, as the initial treatment for moderate-to-severe plaque psoriasis, from the perspective of a United States payer.
Methods: We developed a Markov model with health states based on Psoriasis Area Severity Index (PASI) response rate categories and death. The probabilities of achieving PASI responses were derived from a network meta-analysis utilizing published efficacy data. Health care costs and effectiveness, measured in quality-adjusted life-years (QALYs), were estimated. The incremental costs per QALY gained for each biologic/targeted first-line treatment, in comparison to a mix of conventional treatments, were analyzed to determine relative cost-effectiveness among these therapies.
Results: Over a 10-year period, the incremental cost per QALY gained, when compared to a mix of topical therapies, phototherapies, and other oral systemic therapies, was found to be lowest for brodalumab, infliximab, apremilast, and tildrakizumab. Following closely were secukinumab, ixekizumab, guselkumab, adalimumab, ustekinumab, and etanercept. Tildrakizumab consistently maintained its position relative to the other treatments across various scenarios.
Conclusions: Tildrakizumab emerges as one of the most cost-effective first-line therapies for moderate-to-severe plaque psoriasis, surpassing the cost-effectiveness of secukinumab, ixekizumab, guselkumab, adalimumab, ustekinumab, and etanercept.
