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.

Systemic treatment with corticosteroids in psoriasis--health care provision far beyond the S3-guidelines.

BACKGROUND: The basis of induction therapy for psoriasis in Germany is the S3-guideline which for moderate to severe psoriasis recommends the systemic agents fumaric acid esters, methotrexate, cyclosporine and the biologicals infliximab, etanercept, adalimumab and ustekinumab. Systemic glucocorticosteroids (GCS) are not proposed. QUESTION: To what extend are systemic glucocorticosteroids prescribed in psoriasis therapy? METHODS: The database of a German nationwide statutory health insurance 2007 was analyzed. Prescriptions of systemic glucocorticosteroids were identified by ATC-encoding. Psoriasis patients with comorbidities requiring systemic glucocorticosteroid medication were analyzed separately. RESULTS: Among 1,423,308 continuously insured patients in 2007 n = 34,728 (2.4 %) were patients with psoriasis. The most prescribed systemic agents were corticosteroids (2774 patients), followed by methotrexate (853), fumaric acid esters (342), retinoids (110) and cyclosporine A (105). Even after excluding patients with psoriatic arthritis, systemic corticosteroids were still the most often prescribed systemic drugs. The average number of DDD (Defined Daily Doses) per insured patient was 120 (general practitioners), 141 (internists) and 68 (dermatologists). These results were confirmed by a control analysis with IMS data. CONCLUSIONS: In Germany, psoriasis is often treated with systemic corticosteroids though these are not recommended by the S3-guideline. General practitioners and internists are the main prescribers.

Rational for statin use in psoriatic patients.

Psoriasis represents a common skin disease which is clinically manifested by chronic cutaneous lesions. It has been observed that psoriasis is associated with an increased risk of cardiovascular diseases, which is contributed to the inappropriate lipid metabolism. Statins are commonly used in clinical practice to lower cholesterol concentration and, accordingly, decrease the individual risk of developing a cardiovascular episode. There have been reports that statin administration could also result in better management of psoriasis. The observed beneficial effects are contributed to the effects on lipid metabolism, including that in skin, as well as anti-inflammatory and immunomodulatory properties of statins. Simvastatin and atorvastatin were found to improve the clinical outcome in patients with psoriatic skin lesions. Clinically, the effectiveness of this novel treatment was confirmed by the significant reduction in PASI score. To date several cases have been reported in which atorvastatin or pravastatin worsened psoriasis. Based on these results, it seems that statins represent a promising class of medications which could be extensively used in psoriasis.

National and multinational guidelines in Europe: results from an online survey on awareness of different national and European psoriasis guidelines.

Guidelines can be developed on a national or multinational level. There are discussions concerning the relevance of different guidelines at different regional levels. Guidelines' evaluation can be approached by looking at the items "awareness", "agreement", "adoption" and "adherence". To assess the awareness of national and European (EDF/EADV) guidelines as a means of guidelines' evaluation. Online survey in five selected European countries (Germany [D], Spain [E], France [F], Italy [I], and the United Kingdom [UK]) among 257 dermatologists assessing awareness of different guidelines (European [EDF/EADV], German, Spanish, French, British). Participants were volunteers registered with a field market research company database. Mean awareness of EDF/EADV guidelines in all countries was 54 %, with lower results in the UK (33 %) and Germany (37 %) and higher awareness in Spain (63 %) and Italy (79 %). Awareness of the national guidelines was very high within the respective countries (mean 92 %). The European guidelines where always the best known guidelines after the respective national guidelines. The most important tools for dissemination of all guidelines were the original publication (63 %) and scientific presentations (46 %).This study identified widespread interest in guidelines as assessed by the grade of awareness. Awareness of European guidelines was higher in countries with late development of national guidelines (i.e. Spain and Italy) compared to countries with early development of own national guidelines such as Germany and the UK. National guidelines can reach almost complete awareness within their respective countries. The original publication is still the most important dissemination tool for guidelines.