Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice
Costanzo, Antonio (Humanitas Research Hospital (Itàlia))
Llamas-Velasco, Mar (Hospital Universitario de la Princesa (Madrid))
Fabbrocini, Gabriella (University of Naples Federico II)
Cuccia, Aldo (San Donato Hospital)
Rivera, Raquel (Hospital 12 de Octubre (Madrid))
Gaarn Du Jardin, Kristian (Almirall R&D)
Kasujee, Ismail (Almirall R&D)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Carrascosa, José Manuel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	Tildrakizumab (TIL) is an interleukin (IL)-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis with long-term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed. The TRIBUTE study (open-label, Phase IV) assessed the efficacy and impact on health-related quality of life (HRQoL) of TIL 100 mg in adult moderate-to-severe psoriasis patients (naïve to IL-23/Th17 pathway inhibitors) in conditions similar to clinical practice. Key efficacy measure was Psoriasis Area Severity Index (PASI). HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) and Skindex-16. Additional patient-reported outcomes included Pain-, Pruritus- and Scaling-Numerical Rating Scale (NRS), Medical Outcome Study (MOS)-Sleep, Work Productivity and Activity Impairment (WPAI), Patient Benefit Index (PBI) and Treatment Satisfaction Questionnaire for Medication (TSQM). One hundred and seventy-seven patients were enrolled (six patients did not complete the study). After 24 weeks, the proportion of patients achieving PASI scores ≤ 3, PASI 75, PASI 90 and DLQI 0/1 was 88. 4%, 92. 5%, 74. 0% and 70. 4%, respectively. Skindex-16 overall score improved (mean absolute change from baseline, MACB [95%CI]: -53. 3 [-58. 1, -48. 5]). Significant benefits (MACB [95%CI]) were found on pruritus-, pain- and scaling-NRS scores (-5. 7 [-6. 1, -5. 2], -3. 5 [-4. 1, -3. 0] and -5. 7 [-6. 2, -5. 2], respectively), MOS-Sleep (-10. 4 [-13. 3, -7. 4] Sleep problems Index II) and WPAI (-36. 4 [-42. 6, -30. 2] activity impairment, -28. 2 [-34. 7, -21. 7] productivity loss, -27. 0 [-32. 9, -21. 1] presenteeism and -6. 8 [-12. 1, -1. 5] absenteeism). 82. 7% of patients reported PBI ≥ 3 and the mean (SD) global TSQM score was high (80. 5 [18. 5]). Only one serious treatment-emergent adverse event was reported (not-related to TIL). TIL 100 mg treatment after 24 weeks in conditions close to real clinical practice showed a quick and high improvement in psoriasis signs and HRQoL. Patient reported improvements in sleep outcomes and work productivity, relevant benefits and high treatment satisfaction. The safety profile was favourable and consistent with Phase III trials.
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Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Journal of the European Academy of Dermatology and Venereology, Vol. 37 Núm. 10 (october 2023) , p. 2004-2015, ISSN 1468-3083

DOI: 10.1111/jdv.19229
PMID: 37246505

12 p, 341.9 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles