Background Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin-17A and shows long-lasting efficacy and safety in plaque psoriasis. More evidence is required to optimize secukinumab dosing according to clinical response. Objectives GAIN compared the efficacy and safety of secukinumab 300 mg every 2 weeks (q2w) with 300 mg every 4 weeks (q4w) in patients achieving >= 75% improvement in Psoriasis Area and Severity Index (PASI 75) but not PASI 90 after 16 weeks. Methods In total, 772 patients with moderate-to-severe plaque psoriasis received secukinumab 300 mg subcutaneously at baseline and weeks 1, 2, 3 and 4, then q4w until week 16. At week 16, patients with PASI >= 75 to PASI < 90 were randomized 1: 1 to continue q4w dosing (n = 162) or switch to q2w (n = 163) to week 32. The primary endpoint was superiority of q2w to q4w dosing for PASI 90 response at week 32. Results PASI 90 response at week 32 was numerically greater with secukinumab 300 mg q2w than with secukinumab 300 mg q4w in suboptimal responders, but this did not reach statistical significance (64 center dot 4% vs. 57 center dot 4%; odds ratio 0 center dot 64, 95% confidence interval 0 center dot 39-1 center dot 07; P = 0 center dot 087). Although the primary endpoint was not met, absolute PASI was significantly lower at week 32 in q2w vs. q4w patients (2 center dot 11 vs. 2 center dot 84, P = 0 center dot 024). Significantly more patients with q2w vs. q4w dosing showed minimal disease activity (Investigator's Global Assessment score 0 or 1: 73 center dot 0% vs. 64 center dot 1%, P < 0 center dot 05) and improved quality of life (Dermatology Life Quality Index score 0 or 1: 58 center dot 9% vs. 50 center dot 6%, P < 0 center dot 05) at week 32. No new or unexpected safety signals arose. Conclusions Most patients achieved PASI 90 response with secukinumab q4w. There was potential benefit of q2w dosing in some suboptimal responders. Continued q4w treatment can improve response even after 16 weeks.

Background Assessment of psoriasis is exclusively done measuring severity using somatic scores such as the psoriasis area and severity index or patient-reported outcomes such as the dermatology life quality index. There is no established tool to measure a patient's individual psoriasis activity over time. Objectives Development of a new tool to classify psoriasis activity types. Methods Open patient interviews were performed and adapted in several steps and by using different groups of patients. Wording of the tool's axis and description how to use it was optimized with the input of patients. The final ActiPso tool was used in a prospective study in psoriasis patients. Results Four activity types could be identified describing psoriasis intensity (e.g. severity, itch, pain) over one typical year and an event/trigger type describing flares. In the study in 586 psoriasis patients of the 536 patients eligible for analysis 40.9% self-classified as type 1 ('stable'), 22.6% as type 2 ('unstable'), 30.6% as type 3 ('winter type') and 6.0% as type 4 ('summer type'), respectively. Flares of psoriasis as identified by the event/trigger type were reported in 36.1% of patients with activity type 1, 67.8% with type 2, 73.8% of type 3 and 59.4% of type 4, respectively. Conclusions Interviewed patients were able to describe their course of psoriatic disease and to name potential triggering factors. By doing so, activity types of psoriasis were defined for the first time and the importance of events/triggers for flares described and integrated into ActiPso types as a basis for advanced patient-centric management. A limitation of ActiPso is that in regions with no seasonal variations types 3 and 4 may not apply.

Background Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate-to-severe psoriasis. Trial protocols specify transition periods and prohibit concomitant psoriasis medication. Data are therefore needed on secukinumab effectiveness and safety in routine clinical practice. Objectives The PROSPECT study assesses prior and concomitant psoriasis treatments and transition periods in subjects receiving secukinumab. Here, we report interim effectiveness and safety data for secukinumab in the context of prior and concomitant treatments. Methods PROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate-to-severe psoriasis with a decision to receive secukinumab 300 mg were included. Results Of 1988 subjects, 1238/1988 (62.4%) were male, and mean age was 48.1 +/- 13.7 years. Mean baseline Psoriasis Area and Severity Index (PASI) score was 17.7 +/- 12.5. 90.9% of subjects had prior systemic treatment. Concomitant treatment was recorded in 44.3% of subjects. Median duration of transition period was 14.0, 30.0 and 44.5 days from prior topical, conventional systemic and biologic treatments. At Week 24, PASI75/90/100 was reached by 86.1%, 68.5% and 39.7% of subjects who started secukinumab treatment at baseline. No unexpected safety signals were observed. Conclusion PROSPECT provides a large prospective real-world analysis of secukinumab treatment and includes prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. Secukinumab effectiveness and safety were comparable to that seen in the phase 2/3 secukinumab clinical trial programme.

Background Dry skin is a frequent and multifaceted condition which can be associated with skin irritation, itch, patient discomfort and manifest skin disease. In spite of being frequent, little is known about the epidemiology of dry skin in the population. Objective To determine the prevalence of dry skin in the German adult population. Methods Data of 48 630 employed persons were assessed on a cross-sectional level in whole-body examinations by experienced dermatologists during company-based skin screenings conducted in 343 German companies. Next to the current dermatologic findings, age, gender, allergies, atopic diseases and the skin type were assessed. Results In total, n = 14 300 persons (29.4%) were rated as having xerotic skin. Older age but not gender was associated with xerosis. In the regression analyses controlling for age and gender, dry skin was a significant predictor for: axillary dermatitis (OR: 4.51; CI 2.70-7.54), atopic eczema (OR: 3.99; CI 3.42-4.65), exsiccation eczema (OR: 2.96; CI 2.40-3.65), psoriasis (OR: 1.57; CI 1.38-1.78), plantar warts (OR: 1.42; CI 1.26-1.60), seborrhoeic dermatitis (OR: 1.28; CI 1.16-1.42) and atopic disposition (OR: 1.17; CI 1.12-1.22). Conclusion Dry skin is a frequent condition in the adult general population and needs special attention. Known risk factors may facilitate identifying patients at risk for deterioration.

Background Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care. Objective This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and Swiss Dermatology Network of Targeted Therapies (SDNTT) with respect to treatment choice, age and gender. Methods The German and Swiss psoriasis registries observe patients recruited at first-time use of systemic drugs. Within 10 years, clinical [Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)] and patient-reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis data set includes n = 4894 patients from PsoBest and n = 449 from SDNTT with mean follow-up time of 7.5 months. Results A total of 5343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years +/- 14.5, PASI 14.2 +/- 9.7, BSA 22.7 +/- 19.7, DLQI 11.3 +/- 7.2). The most important patient needs were to 'get better skin quickly' and to 'be healed of all skin defects'. Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side-effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy. Conclusion Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analysing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.

BackgroundSecukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe psoriasis. However, as per study protocols, transition periods from prior psoriasis treatments of a defined minimal length were required and use of concomitant psoriasis medication was prohibited. There is therefore a lack of data on the effect of shorter transition periods and concomitant psoriasis treatment with other pharmacologically active substances on the effectiveness and safety of secukinumab in routine clinical practice. ObjectivesThe PROSPECT study was designed to assess prior and concomitant use of psoriasis treatments in subjects receiving secukinumab and the duration of transition periods from prior treatments to secukinumab. Here, we report the baseline characteristics and the duration of transition period in an interim analysis of the first 805 subjects. MethodsPROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate to severe psoriasis with a decision to receive secukinumab were included. ResultsThe majority of subjects were male (491/796, 61.7%), with a mean age of 47.7 years (SD 13.7). The baseline Psoriasis Area and Severity Index (PASI) was available for 92.4% (744/805) of subjects, and mean baseline PASI was 17.5 (SD 13.1); 93.4% (752/805) of subjects had signs of high disease severity. Use of concomitant treatment increased with the number of signs. Within the last 12 months prior to inclusion, 10%, 40%, and 28% of subjects had received topical, conventional systemic, or biologic treatments as their last prior psoriasis therapy, respectively, and 22% of subjects had not received any psoriasis therapy. Discontinuation of prior treatment due to adverse events was high in subjects with conventional systemic treatment (93/413, 22.5%) compared to biologic treatment (5/210, 2.4%). The median duration of the transition period was 14.0, 30.5, and 38.0 days for prior topical, conventional systemic, and biologic treatments, respectively. ConclusionPROSPECT is the first study to investigate prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. The majority of the subjects had a high disease burden and use of concomitant treatment increased with disease severity. The duration of the transition period depended on prior treatment.

IntroductionInequality between age groups has been demonstrated in the prescription of biologics, yet systematic real-world data about age-related differences in psoriasis care are missing.ObjectiveTo investigate disparities in psoriasis characteristics by age groups and to identify potential impact on psoriasis health care.Patients and MethodsData analysis included 3615 patients from the German psoriasis registry PsoBest, which observes adult patients with moderate-to-severe psoriasis or psoriatic arthritis (PsA) on systemic treatment over a time period of 10 years.ResultsWith 2376 participants (65.7%), the majority of patients was assigned to the age group 35-64, followed by 776 (21.4%) and 463 (12.8%) for the age groups 18-34 and 65+, respectively. Psoriasis vulgaris was the most frequent form of psoriasis with nearly 90% patients affected. Appearance of psoriasis forms did not differentiate significantly between the age groups except for erythrodermic psoriasis, which was more frequent in the elderly than in patients aged 35-64 (1.9%, P 0.048). Nail psoriasis appeared significantly more often in patients aged 35-64 (55.5%, P 0.001) and also showed the highest number of nails involved (6.9 3.3). PsA was less frequent in the age group 18-34 (9.5%, P 0.001). This group showed the highest rate of scalp psoriasis (85.8%) compared to the elder age groups (P 0.001). Biologicals were used significantly less in younger patients (16.2%) compared to the age groups 35-64 (23.9%, P 0.001) and 65+ (21.8%, P 0.042).ConclusionMiddle-aged patients show higher rates of PsA and nail psoriasis, which may explain age-dependent disparities in health care including the use of systemic treatment.

BackgroundPsoriasis vulgaris (PV) is an autoimmune-related chronic inflammatory disease, which appears mostly in skin, but also affects the vascular and metabolic system. The incidence of PV is 2-3% in the general population and there is still no possibility to cure. Trigger factors have been identified to initiate and maintain inflammation in the skin, which is characterized by Th1-, Th17- and Th22- cells.ObjectiveWe hypothesize that the damage-associated molecular pattern (DAMP) molecule high mobility group box 1 (HMGB1) plays a role in the pathogenesis of PV. HMGB1 is a DNA-binding protein located in the nucleus, which acquires cytokine-like properties once released from the cell upon necrotic cell death or actively secreted by immune cells in inflammation and cancer.MethodsWe recruited 90 psoriatic patients under and without therapy with mild, intermediate and severe progression of disease, defined by the Psoriasis Area Severity Index. Serum levels of HMGB1 in patients with PV were detected by enzyme-linked immunosorbent assay (ELISA).ResultsOur results show an increased level of HMGB1 in the sera of patients with PV in comparison to healthy donors. Furthermore, our analyses reveal that HMGB1 levels are significantly increased with disease progression and are downregulated after standard therapies for PV have been conducted.ConclusionOur data provide insights into a possible role of HMGB1 for inflammation in PV.