Retrospective Analysis in Patients With Moderate to Severe Plaque Psoriasis Treated With Tildrakizumab: Real-Life Clinical Data

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Abstract

Background: Interleukin (IL)-23 antagonists have shown great efficacy with minimal side effect profile in clinical trial data for the treatment of moderate to severe plaque psoriasis. As of yet, there have been no published data regarding real-world patients who have received tildrakizumab therapy. Objectives: To analyze real-world efficacy and safety of tildrakizumab in patients with moderate to severe plaque psoriasis. Methods: A retrospective chart review was performed at a large urban academic medical center for all patients treated with tildrakizumab for moderate to severe plaque psoriasis. Demographic information, Psoriasis Area and Severity Indexs(PASIs) from initial presentation and 12-month follow-up, comorbidities, and any possible adverse events were collected and analyzed statistically. Results: 30 patients on tildrakizumab therapy were included in the analysis. Overall, the mean ± standard deviation of the PASIs was 15.8 ± 11.8 at initial visit and 1.5 ± 2.9 at 12-month follow-up (P < .001). No serious adverse events were reported. Conclusions: Tildrakizumab has shown efficacy in clinical trials and this real-world cohort for the treatment of moderate to severe plaque psoriasis with a good safety profile. Future studies should be done to assess the efficacy of tildrakizumab compared with other IL-23 inhibitors.

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Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review

April W. Armstrong, Charlotte Read (2020)

Approximately 125 million people worldwide have psoriasis. Patients with psoriasis experience substantial morbidity and increased rates of inflammatory arthritis, cardiometabolic diseases, and mental health disorders.

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Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.

Anish Mehta, Kristine Nograles, Kenneth KY Liu … (2017)

Tildrakizumab is a high-affinity, humanised, IgG1 κ antibody targeting interleukin 23 p19 that represents an evolving treatment strategy in chronic plaque psoriasis. Previous research suggested clinical improvement with inhibition of interleukin 23 p19. We did two phase 3 trials to investigate whether tildrakizumab is superior to placebo and etanercept in the treatment of chronic plaque psoriasis.

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Long‐term efficacy and safety of tildrakizumab for moderate‐to‐severe psoriasis: pooled analyses of two randomized phase III clinical trials (re SURFACE 1 and re SURFACE 2) through 148 weeks †

K Reich, R.B. Warren, L. Iversen … (2019)

Summary Background Tildrakizumab is a specific anti‐interleukin‐23p19 monoclonal antibody approved for the treatment of plaque psoriasis. Objectives To evaluate the long‐term efficacy and safety of tildrakizumab treatment for patients with moderate‐to‐severe psoriasis for up to 148 weeks. Methods Pooled analysis from two double‐blind, randomized controlled trials: reSURFACE 1 and reSURFACE 2. Efficacy was assessed for responders (≥ 75% improvement in Psoriasis Area and Severity Index; PASI 75) and partial responders (PASI 50–75) to tildrakizumab 100 mg and 200 mg at week 28 who were maintained on the same dose (administered every 12 weeks), and for partial responders or nonresponders (PASI < 50) to etanercept 50 mg at week 28 who, after a 4‐week washout, were switched to tildrakizumab 200 mg (administered at weeks 32 and 36, and every 12 weeks thereafter). Safety was assessed in the all‐patients‐as‐treated population. Three different methods of imputing missing data were used: nonresponder imputation (NRI), multiple imputation and observed cases. The Clinicaltrials.gov numbers are NCT01722331 (reSURFACE 1) and NCT01729754 (reSURFACE 2). Results At week 148 (NRI), 72·6%, 53·8% and 28·9% of tildrakizumab 100‐mg responders and 80·2%, 59·9% and 32·6% of tildrakizumab 200‐mg responders had PASI 75, 90 and 100 responses, respectively. For partial responders to tildrakizumab 100 mg and 200 mg, the proportions of patients achieving PASI 75, 90 and 100 responses were 32·5%, 25·0% and 10·0%; and 47·1%, 27·5% and 12·8%, respectively. For patients who were partial responders or nonresponders to etanercept, the proportions of patients achieving PASI 75, 90 and 100 responses were 66·9%, 43·8% and 14·9% at week 148. Rates of discontinuations due to adverse events [tildrakizumab 100 mg: 1·7 per 100 patient‐years (PYs); tildrakizumab 200 mg: 1·2 per 100 PYs] and exposure‐adjusted rates of serious adverse events (5·9 per 100 PYs; 5·5 per 100 PYs), severe infections (1·1 per 100 PYs; 1·1 per 100 PYs), malignancies (0·6 per 100 PYs; 0·4 per 100 PYs) and major adverse cardiovascular events (0·4 per 100 PYs; 0·5 per 100 PYs) were low. Conclusions Tildrakizumab was well tolerated and efficacy was well maintained in week 28 responders who continued tildrakizumab treatment through 3 years, or improved among etanercept partial responders or nonresponders who switched to tildrakizumab. What's already known about this topic? Tildrakizumab 100 mg and 200 mg are efficacious and well tolerated with short‐term use in the treatment of patients with moderate‐to‐severe plaque psoriasis. What does this study add? High levels of efficacy are maintained for up to 3 years of psoriasis treatment with tildrakizumab. There is a favourable long‐term safety profile with both tildrakizumab 100 mg and 200 mg, with a low incidence of adverse events of special interest through 3 years.

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Author and article information

Contributors

Nancy W. Wei: (View ORCID Profile)

Journal

Title: Journal of Psoriasis and Psoriatic Arthritis

Abbreviated Title: Journal of Psoriasis and Psoriatic Arthritis

Publisher: SAGE Publications

ISSN (Print): 2475-5303

ISSN (Electronic): 2475-5311

Publication date Created: April 2022

Publication date (Electronic): March 29 2022

Publication date (Print): April 2022

Volume: 7

Issue: 2

Pages: 55-59

Affiliations

[1 ]The Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA

Article

DOI: 10.1177/24755303221077211

SO-VID: 75de6dc1-e0bb-4630-a63f-a3092fd69845

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http://journals.sagepub.com/page/policies/text-and-data-mining-license

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