Abstract Plaque psoriasis, an autoimmune disease predominantly affecting the skin, is accompanied by itching in 60–90% of the patients, which may seriously affect health-related quality of life (HRQoL). Female gender and high psoriasis area and severity index (PASI) scores are associated with more severe itch. Reduction of itch is one of the most desired treatment outcomes for patients. Tildrakizumab is an interleukin-23p19 inhibitor indicated for the treatment of moderate-to-severe plaque psoriasis with demonstrated long-term efficacy and safety.1 The primary objective of this study is to assess the improvement of itching in patients with plaque psoriasis under tildrakizumab therapy in routine care. The study is a monocentric, national, open, prospective, non-interventional, uncontrolled, single group, post-authorization, observational study carried out at a single study site in Austria for 28 weeks. Itch was assessed by the Numeric Rating Scale (NRS) 0–10 at each visit. Patients with medium-to-severe pruritus were eligible for inclusion in the study. The HRQoL instrument was Dermatology Life Quality Index-Relevant (DLQI-R). Effectiveness was assessed by PASI score. A total of 24 patients were included (58.0% male, mean age of 48 years, 42.0% current smokers). Seven patients had a family history of psoriasis and nine patients reported one or more comorbidities like obesity, dyslipidaemia, hypertension, and diabetes mellitus. The mean itch NRS score decreased from 7.3 at baseline to 2.7 at Week 4 and to 0.4 at Week 28. At baseline, 23 of 24 patients reported an itch NRS ≥4. In only 4 weeks, two-thirds of the patients (66.7%) reached the minimal clinically important difference reduction of ≥4 points, 18 of 23 at Week 16 and all of them at Week 28. At Week 4, after only one injection of tildrakizumab, 30.4% reported an itch NRS 0/1, and at Week 28 all but two patients reported no or minimal itch. The mean DLQI-R score decreased from 12.6 at baseline to 3.2 at Week 28. Mean PASI decreased from 13.2 at baseline to 0.6 at Week 28 which resulted in 91.3% of patients achieving PASI ≤1 at the end of the study. No patients discontinued due to adverse events. In a real-world setting, tildrakizumab quickly and effectively improved itch in psoriasis patients as well as skin symptoms and HRQoL, without safety concerns, and this improvement was maintained through Week 28.
Read full abstract