Tildrakizumab in Combination With Topical Halcinonide 0.1% Ointment for Treating Moderate to Severe Plaque Psoriasis

August 2023 | Volume 22 | Issue 8 | 766 | Copyright © August 2023


Published online July 31, 2023

doi:10.36849/JDD.6830

Jerry Bagel MD MS, Kristin Novak CCMA CCRC, Elise Nelson LPN CCRC

Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ

Abstract
Background: This prospective, open-label study evaluated the effectiveness and safety of tildrakizumab plus topical halcinonide ointment in psoriasis patients.
Methods: Adults (age greater than or equal to 18 years) with moderate to severe plaque psoriasis (body surface area [BSA] greater than or equal to 10%, physician's global assessment [PGA] greater than or equal to 3, psoriasis area severity index [PASI] greater than or equal to 12) received tildrakizumab (100 mg; s.c.) at weeks 0, 4, and 16. Patients with BSA >3% at week 16 received additional halcinonide 0.1% twice daily for 4 weeks (week 20) and were followed for another 4 weeks (week 24); those with BSA less than or equal to 3% were followed to week 24.
Results: Twenty-five patients were enrolled (mean age 52.6 years; 68% male). The proportion of all patients achieving BSA less than or equal to 3% was 52.2% at week 16, 73.7% at week 20 (after 4 weeks of adjunctive halcinonide in patients with BSA >3% at week 16), and 84.2% at week 24 (4 weeks after halcinonide discontinuation). PASI 75 was attained in 60.9% of all patients at week 16, and 73.7% at weeks 20 and 24. In patients adding halcinonide, improvements from baseline in mean BSA, PGA, and PGA x BSA increased from week 16 (55%, 29%, and 64%, respectively) to week 20 (78%, 51%, and 88%, respectively), and were maintained through week 24. Quality of life improved with tildrakizumab monotherapy and further with adjunctive halcinonide. Adverse events (AEs) were infrequent. No serious AEs or discontinuations due to AEs were noted.
Conclusion: Tildrakizumab plus topical halcinonide ointment is safe and effective in controlling psoriasis for patients inadequately responding to tildrakizumab monotherapy.

Bagel J, Novak K, Nelson E. Tildrakizumab in combination with topical halcinonide 0.1% ointment for treating moderate to severe plaque psoriasis. J Drugs Dermatol. 2023;22(8):766-772. doi:10.36849/JDD.6830

INTRODUCTION

Psoriasis is a chronic inflammatory skin disease prevalent in approximately 3% of adults in the United States.1 It is characterized by marked inflammation and increased epidermal thickness resulting from infiltration of the skin with activated T cells and abnormal proliferation and differentiation of keratinocytes. Moderate to severe psoriasis is associated with a number of comorbidities including metabolic syndrome, cardiovascular and cerebrovascular diseases, depression, and anxiety.2 Patients may also develop mental health conditions2 and have reduced quality of life.3 

No cure is currently available for psoriasis and treatments focus on controlling symptoms. Therapeutic options include topical therapy for limited psoriasis, and phototherapy, systemic medications, and biologic agents for extensive psoriasis.4 For plaque psoriasis, the National Psoriasis Foundation suggests an acceptable treatment response of less than or equal to 3% affected body surface area (BSA) and a target response of BSA less than or equal to 1% after treatment for 3 months.5 

Among biologic agents, tildrakizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to interleukin-23 (IL-23) and inhibits its receptor interaction.6,7 Randomized controlled trials showed that tildrakizumab monotherapy was efficacious compared with placebo for psoriasis treatment and well tolerated in patients with chronic moderate to severe plaque psoriasis.8-13

For patients lacking an adequate response to biologics alone, combinations of biologic therapy with other psoriasis treatments can be used for improvement.14-18 For example, topical medications have been shown to augment clinical responses without causing additional adverse effects when applied with biologics.17,18 A phase 3b, randomized trial showed that significantly more patients with moderate to severe psoriasis attained an adequate response after treatment with etanercept plus topical clobetasol propionate foam vs etanercept monotherapy for 12 weeks.19 Another randomized, controlled study found faster clearance of psoriasis lesions with a combination of adalimumab plus topical calcipotriol/betamethasone compared with adalimumab alone.20 Safety outcomes were not affected by addition of topical medications in these studies.19, 20 

In the present, real-world study, topical halcinonide 0.1% ointment - a highly potent corticosteroid for relieving 
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