Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis.

PURPOSE: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis. METHODS: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups. RESULTS: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60. CONCLUSIONS: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

Temporary tattoos to simulate skin disease: report and validation of a novel teaching tool.

PURPOSE: Dermatology is a visual specialty requiring examination and description of skin lesions and the development of analytic skills to establish a diagnosis. Student education in dermatology is challenged by several factors. Although 10% to 15% of a general practitioner's consultations are related to the skin, dermatology is often underrepresented in undergraduate medical curriculums. In addition, more serious lesions, such as malignant melanoma (MM), are promptly biopsied and may not be available for students' examination. The authors carried out this study to learn whether a novel educational tool, a temporary tattoo, could successfully simulate an MM. METHOD: Eighty-one dermatologists and 14 dermatology residents participated in this validity study of a tattoo applied to the arm of a standardized patient (SP) to simulate an MM. The study was conducted at the 82nd Annual Canadian Dermatology Association Conference held in June 2007 in Toronto, Canada. RESULTS: A correct diagnosis was made by 93.8% (76/81) of the dermatologists and 90.5% of the participants (86/95) overall. The tattoo was also evaluated as being very realistic on a five-point Likert scale. CONCLUSIONS: The validation of the tattoo shows potential for use in medical education, such as SP visits and examinations. This teaching tool can be used to simulate a variety of skin lesions, providing a way to visually examine a lesion on the skin of an SP, which would enhance the medical student's learning experience.