Secukinumab use in patients with moderate to severe psoriasis, psoriatic arthritis and ankylosing spondylitis in real-world setting in Europe: Baseline data from SERENA study

INTRODUCTION: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. METHODS: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. RESULTS: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m2) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89-1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. CONCLUSION: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting

Introducing a simplified titration scheme for dimethylfumarate (DMF) in patients with moderate-to-severe psoriasis: a case series

Dimethylfumarate (DMF) is approved for the treatment of moderate to severe psoriasis. In clinical practice, DMF tolerability is improved by slowly up-titrating the dose. Time-to-onset of gastrointestinal complaints (a common adverse event [AE]) is ∼4 weeks, coinciding with the increase in dose to one 120-mg tablet. The average DMF dose during maintenance treatment is also often lower than the maximum indicated dose of 720 mg/day. Here, a simplified dose-escalation strategy is described, where twice-daily DMF was up-titrated to a maximum of 720 mg/day (if required) in week 7. Ten patients received DMF according to the new scheme (maximum dose: 720 mg/day [n = 5], 480 mg/day [n = 3; escalation halted early due to good efficacy], and ≤240 mg/day [n = 2] by week 12). Mean Psoriasis Area Severity Index (PASI) decreased from 7.2 to 0.9 between weeks 0 and 24. Absolute Psoriasis Area Severity Index (aPASI) was ≤3 for 7 and 6 patients at weeks 12 and 24, respectively. Affected BSA and DLQI demonstrated similar improvements. Treatment was terminated in 3 patients due to AEs (diarrhea and lymphopenia). In this case series, simplified DMF dosing was largely well-tolerated and provided similar efficacy to the current scheme. Higher doses were reached more quickly and the dosing regimen was simpler for patients (twice instead of three times daily)

Response to fumaric acid esters for plaque type psoriasis in real-world practice is largely independent of patient characteristics at baseline – a multivariable regression analysis from the German Psoriasis Registry PsoBest

Objectives Fumaric acid esters (FAEs) are a well-established treatment option for long-term therapy of moderate to severe plaque psoriasis. This study examines effectiveness of FAEs for the treatment of plaque psoriasis in real-world practice at 12 months and if patient characteristics affect the odds of clinical response. Methods A descriptive, multivariable logistic regression analysis was conducted in a cohort drawn from the German registry PsoBest. Baseline patient characteristics were assessed as potential treatment effect modifiers. Results 444 patients (mean age 47.0 years, 39.0% female) were eligible for response analysis using nonresponder imputation at month 12. Of these, 39.6% achieved clinical response, i.e. Psoriasis Area and Severity Index (PASI) ≤ 3 or skin clearance. In logistic regression analysis (R2 = 0.114), only baseline PASI was a significant factor: patients with PASI 20. Neither sex, age, body weight, disease duration, comorbidity nor pretreatment had an impact on the odds of response (p > .05). Conclusions FAEs showed a favorable response at 12 months, largely independent of patient characteristics

Chronic hand eczema in Germany: 5-year follow-up data from the CARPE registry

Background: The CARPE registry was set up in 2009 to prospectively investigate the management of patients with chronic hand eczema (CHE). Objectives: To report comprehensive follow-up data from the CARPE registry. Patients and methods: We investigated sociodemographic and clinical characteristics, provision of medical care, physician-assessed outcomes, and patient-reported outcomes (PROs). Data were collected between 2009 and 2016, with up to 5 years of follow-up, and are reported descriptively. Results: Overall, 1281 patients were included in the registry (53.7% female). Mean age was 47.0 years. Of the patients, 793 and 231 completed the 2-year follow-up and 5-year follow-up, respectively. At baseline, 5.4% had changed or given up their job because of CHE, the average duration of CHE was 6.1 years, and, in 22.4%, the CHE was severe according to physician global assessment. Systemic treatment (alitretinoin, acitretin, and methotrexate) was prescribed at least once to 39.0% of the patients during the course of the follow-up. Disease severity, quality of life and treatment satisfaction improved over time, and the proportion of patients receiving systemic treatments decreased. Conclusions: Under continued dermatological care, substantial improvements in disease severity and PROs over time was achieved during the course of the CARPE registry, even in patients with long-standing and severe hand eczema

S3 guideline Atopic dermatitis: Part 2 - Systemic treatment.

The present S3 guideline was created based on the European English-language S3 guideline, with special consideration given to the medical conditions in the German-speaking region, and with additions from the previous German-language version, in accordance with the criteria of the AWMF. This second part of the guideline addresses the systemic therapy of atopic dermatitis (AD). It covers topics such as the indication for systemic therapy in children, adolescents, and adult patients with AD. Furthermore, it addresses all medications approved for AD, such as the biologics dupilumab and tralokinumab, the Janus kinase inhibitors abrocitinib, baricitinib, and upadacitinib, as well as conventional immunosuppressive therapies with systemic glucocorticosteroids and ciclosporin. Additionally, it discusses systemic off-label therapies. The first part of the guideline, published separately, includes the definition and diagnostic aspects of AD, describes topical therapy, non-drug therapy approaches, and addresses aspects related to special patient groups