Quality of life and patient-reported symptoms in a Phase 4, real-world study of tildrakizumab in patients with moderate-to-severe psoriasis: Week 28 interim analysis

Abstract

Background

Tildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis. Little real-world evidence is available regarding the effects of tildrakizumab on patients’ health-related quality of life (HRQoL) and patient-reported symptoms.

Objective

This real-world study of tildrakizumab evaluated changes in HRQoL and clinical symptoms in patients with psoriasis.

Materials and methods

In this Week (W)28 interim analysis of a 64-week Phase 4 study (NCT03718299), patients received tildrakizumab 100 mg at W0, W4, and every 12 weeks thereafter. Endpoints were improvement from baseline in Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores through W28.

Results

Of 55 patients enrolled, 53 were assessed at W28. Mean (standard deviation [SD]) total PGWBI score improved from baseline to W28 (change, 3.7 [12.4]; p = .033), as did the positive well-being (1.0 [2.9]; p = .018) and general health (1.5 [2.2]; p < .001) domain scores. Mean (SD) DLQI score improved by −3.9 (4.3) at W4 and by −7.6 (5.1) at W28 (p < .001). Patient-reported symptoms improved starting at W4 (p < .001).

Conclusion

Tildrakizumab treatment improved HRQoL and patient-reported symptoms in patients with psoriasis in a real-world setting. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03718299

Keywords:

• Health-related quality of life (HRQoL)
• psoriasis
• Psychological General Well-Being Index (PGWBI)
• patient-reported outcomes
• tildrakizumab

Acknowledgements

We thank Drs. Tina Bhutani, John Koo, and Stephen J Rozzo for contributions to the studies. Portions of these data were previously presented at the American Academy of Dermatology 2022 Annual Meeting (AAD 2022) in Boston, MA, on March 25–29, 2022, and at the 2022 Winter Clinical Dermatology Conference in Koloa, HI, on January 14–19, 2022.

Disclosure statement

NB is an adviser, consultant, and investigator for AbbVie, Almirall, Arcutis, Beiersdorf, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, Cara, Dermavant, EPI Health, Ferndale, Galderma, InCyte, ISDIN, Johnson & Johnson, LaRoche-Posay, LEO Pharma, Lilly, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharma, and Verrica. JH has been a speaker, adviser, and consultant for AbbVie, Amgen, Celgene, Lilly, Janssen, and Novartis; an adviser for Galderma, Mayne, and Sanofi Regeneron; an adviser and consultant for Ortho Dermatologic; and a speaker and adviser for Sun Pharma. BS is an employee of Sun Pharmaceutical Industries, Inc. JGV reports nothing to disclose.

Data availability statement

Data and other documents will be made available after publication, with no end date, to anyone who submits a reasonable request to the study sponsor.

Additional information

Funding

The study was funded by Sun Pharma. Analyses were funded by Sun Pharma. Medical writing and editorial support were provided by Elisabetta Lauretti, PhD, of AlphaBioCom, a Red Nucleus company, and funded by Sun Pharma.