Secukinumab demonstrates superiority over narrow-band ultraviolet B phototherapy in new-onset moderate to severe plaque psoriasis patients: Week 52 results from the STEPIn study.

BACKGROUND: Biologic treatments have been studied mainly in patients with a long-term history of psoriasis and previous treatment failures. OBJECTIVES: The purpose of this primary analysis of the STEPIn study is to determine whether early intervention with secukinumab in patients with new-onset moderate to severe plaque psoriasis is superior to standard of care treatment with narrow band ultraviolet B (nb-UVB) phototherapy. METHODS: The STEPIn study is a randomized, open-label, multicentre study to investigate early intervention with 52 weeks of secukinumab 300 mg administered subcutaneously versus standard treatment with nb-UVB phototherapy in patients with new-onset (≤12 months) moderate to severe plaque psoriasis (NCT03020199). The primary and additional secondary endpoints were ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at Week 52 and Investigator's Global Assessment (IGA mod 2011) 0/1 response at Week 52, respectively. RESULTS: In the secukinumab and nb-UVB study arms, 77/80 and 76/80 randomized patients received at least one dose of study treatment, respectively. The primary endpoint was achieved: 91.1% (70/77) of patients achieved a PASI 90 response at Week 52 in the secukinumab arm versus 42.3% (32/76) in the nb-UVB arm (p < 0.0001, odds ratio [OR] estimate [95% confidence intervals, CI] = 16.3 [5.6, 46.9]). The additional secondary endpoint was also achieved: 85.7% of patients achieved an IGA 0/1 response at Week 52 in the secukinumab arm versus 36.8% in the nb-UVB arm (p < 0.0001). The safety data were consistent with the safety profiles of secukinumab and nb-UVB with no new or unexpected safety signals. CONCLUSIONS: Secukinumab was superior to nb-UVB in treating patients with new-onset moderate to severe plaque psoriasis. The high and sustained skin clearance observed indicates that biologic treatment for psoriasis may be more effective if used early in the disease course.

The role of topical therapies along the psoriasis patient journey: An overview from the Symposium 'Tailoring topical psoriasis treatments to patients' needs and expectations' of the 30th EADV Congress 2021.

This article summarizes a presentation titled 'The role of topical therapies along the psoriasis patient journey' held at the Satellite Symposium of the 30th European Academy of Dermatology and Venereology Congress. During this session, the role of topical treatments in the management of psoriasis was presented, with a particular focus on the current unmet needs and data gaps. Psoriasis plays a significant role in a patient's daily life, impacting them not only physically but also psychologically and socially. The disease burden increases with duration and severity. Topical therapies are the keystone of the management of psoriasis. About 70%-80% of patients present a mild-to-moderate form of psoriasis that can be successfully treated with topical agents. According to a German recommendation, patients with mild psoriasis should initiate a topical therapy in combination with skin care products. In the real-life setting, the calcipotriol/betamethasone dipropionate (CAL/BDP) fixed combination was the most prescribed topical treatment for beyond-mild patients in Germany, Spain and the United Kingdom. Healthcare professionals also often or very often prescribed topicals as an alternative to non-biologic systemics in certain situations, such as patient preference (51%), contraindication (50%) and to limit side effects (26%). Adjunctive topical therapy to patients using systemic therapy is used to optimize treatment outcomes and improving the quality of life for patients. Topical treatments can be also effective in severe forms of psoriasis. However, there are still some gaps and unmet needs on topical therapy. Ineffectiveness, patient dissatisfaction and adherence are the largest barriers to treatment success. Main strengths of topical treatments include the availability of various topical ingredients and galenics, the adaptability to different anatomical areas and the possible combination with phototherapy and systemics. Moreover, patients in specific situations can benefit from switching to topical treatments (e.g. pregnancy or surgery).

Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial.

Importance: About 1% of children and adolescents worldwide are affected by plaque psoriasis. Objective: To evaluate the long-term efficacy and safety of ixekizumab for pediatric patients with moderate to severe psoriasis. Design, Setting, and Participants: This multicenter randomized clinical trial (IXORA-PEDS) evaluated pediatric patients with plaque psoriasis. Participants were aged 6 years to younger than 18 years; had moderate to severe psoriasis, which was defined as Psoriasis Area and Severity Index (PASI) of 12 or higher, static Physician's Global Assessment (sPGA) score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline; were candidates for phototherapy or systemic therapy; or had psoriasis that was not adequately controlled by topical therapies. Data analysis, which followed the intention-to-treat principle, was conducted from May to October 2021. Interventions: Pediatric patients were randomized 2:1 to receive either a weight-based dose of ixekizumab every 4 weeks or placebo. After a 12-week placebo-controlled period, patients entered a 48-week, open-label ixekizumab maintenance period (weeks 12-60), followed by an extension period that lasted through 108 weeks. A substudy evaluated the randomized withdrawal of ixekizumab after week 60. Main Outcomes and Measures: Efficacy outcomes at week 108 included the percentage of patients achieving 75% (PASI 75), 90% (PASI 90), or 100% (PASI 100) improvement from baseline; an sPGA score of 0 or 1 or score of 0; and improvement of 4 points or higher from baseline in the Itch Numeric Rating Scale. Safety outcomes included assessments of adverse events (AEs), including treatment-emergent AEs, serious AEs, and AEs of special interest, as well as improvement from baseline in a range of challenging body areas. Missing data for categorical outcomes were imputed using modified nonresponder imputation. Results: A total of 171 patients (mean [SD] age, 13.5 [3.04] years; 99 female children [57.9%]) were randomized to either ixekizumab (n = 115) or placebo (n = 56). Of 166 patients who entered the maintenance period, 139 (83.7%) completed week 108 of the trial. Primary and gated secondary end points were sustained through week 108, with patients achieving PASI 75 (91.7% [n = 86]), PASI 90 (79.0% [n = 74]), PASI 100 (55.1% [n = 52]), sPGA 0 or 1 (78.3% [n = 74]), and sPGA 0 (52.4% [n = 49]). Fifty-five patients (78.5%) reported an Itch Numeric Rating Scale improvement of 4 points or higher. In patients who received ixekizumab, at week 108, clearance of nail psoriasis was reported in 68.1% (n = 28), clearance of palmoplantar psoriasis was reported in 90.0% (n = 10), clearance of scalp psoriasis was reported in 76.2% (n = 83), and clearance of genital psoriasis was reported in 87.5% (n = 24). There were no new safety findings during weeks 48 to 108 of the trial, including no new cases of inflammatory bowel disease or candida infection. Conclusions and Relevance: Results of this study showed improvements across patient-reported outcomes and objective measures of complete skin clearance of psoriasis among pediatric patients who received ixekizumab, and these response rates were sustained through week 108 of the trial. Safety of ixekizumab was consistent with previously reported findings in this population and the known safety profile of this treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT03073200.

Calcipotriol/betamethasone dipropionate aerosol foam for the treatment of psoriasis vulgaris: case series and review of the literature.

An aerosol foam formulation of a once-daily, fixed-dose combination of a synthetic vitamin D3 analog/synthetic corticosteroid (calcipotriol [Cal] 50 µg/g and betamethasone dipropionate [BD] 0.5 mg/g) has recently been introduced for the topical treatment of plaque psoriasis in adults. Data from several sources - randomized controlled trials, case reports (as highlighted in this review), and real-world evidence (RWE) - underscore the considerable and rapid clinical response, effectiveness, and favorable safety and tolerability of Cal/BD aerosol foam in mild-to-moderate psoriatic patients previously treated with class 3 or 4 topical corticosteroids, in patients unsatisfied with ongoing phototherapy in combination with topical therapy and in patients with moderate-to-severe psoriasis. In addition, our case series, considered together with other RWE, highlights that Cal/BD aerosol foam is more effective and with greater levels of patient preference and acceptability than comparator preparations. Thus, Cal/BD aerosol foam offers several treatment advantages, including relief of itch, and is an appropriate first-line topical therapy for consideration in patients with psoriasis of any severity.

Hidradenitis Suppurativa After Radical Surgery-Long-Term Follow-up for Recurrences and Associated Factors.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic debilitating skin disease in inverse body areas. Wide excision is recommended in Hurley Stages II to III, but the rate and symptoms of recurrences in long-term follow-up remain unclear. OBJECTIVE: To analyze the allocation of recurrences regarding the operative field, the onset and quality of HS symptoms as well as factors associated with recurrences in long-term follow-up. MATERIAL AND METHODS: Forty-eight patients with Hurley Stage III disease who had undergone 91 wide excisions from 2010 to 2015 were clinically examined regarding postoperative complications and allocation and quality of recurrences. To determine the risk of recurrence, possible surgery, and lifestyle-related associated factors were investigated. RESULTS: Postoperative recurrences of HS were seen in 54.2%. Most recurrences (inflamed nodules) were detected in a <1-cm margin around the operative field (18.7%). Surgery under tumescence local anesthesia showed symptoms in 40.6% compared with 28.6% under general anesthesia. Increased alcohol consumption (p = .027) but not body mass index (p = .11) or smoking behavior (p = .45) had significant effect on relapse of HS. CONCLUSION: Caution must be given especially in surgery with local anesthesia only. Half of patients with HS showed long-term follow-up signs of recurrence after wide excision, most frequently nearby the operation field.