Actas dermo-sifiliograficas最新文献

Background: Recurrent aphthous stomatitis (RAS) and Behçet's disease (BD) are part of the Behçet spectrum disorders (BSD), sharing genetic traits and characterized by recurrent ulcers. No systemic treatment is approved for RAS or incomplete BD, despite significant quality-of-life impacts.

Objective: To evaluate the efficacy of roflumilast, a PDE4 inhibitor, in BSD patients and compare responses between RAS and BD.

Methods: This analytical observational study included a total of 33 patients with BSD (22, RAS; 11, BD) from 5 Spanish centers, followed over 52 weeks. Data were collected retrospectively and prospectively, assessing flare-ups, ulcers, pain, and duration. Statistical models compared outcomes across treatment periods.

Results: Roflumilast significantly reduced all studied response variables, with no loss of long-term efficacy. Differences between RAS and BD were minimal and clinically irrelevant. Adverse events occurred in 63% of patients, mostly mild and self-limiting, with tolerability improved through dose adjustments. Two patients (6.25%) dropped out due to adverse events.

Conclusion: Roflumilast is effective for managing BSD, offering a safe option to address unmet needs in RAS and BD. Its favorable safety profile and long-term efficacy support its use in the routine clinical practice.

Background: The safety and efficacy profile of dupilumab in the management of atopic dermatitis (AD) are established in clinical trials. However, long-term real-world persistence data in Spain are limited.

Objective: The primary endpoint of the study was to assess the 4-year persistence of dupilumab in routine clinical practice in patients with moderate-to-severe AD. Secondary endpoints included the analysis of safety and efficacy profile during the same period of time.

Methods: We conducted a retrospective cohort study of dispensation registries and health records from 5 hospitals. Adults with moderate-to-severe AD starting on dupilumab treatment were followed for 4-years. Dupilumab persistence was estimated using Kaplan-Meier analysis. Efficacy was measured by changes in EASI and IGA scores. Significant adverse events (AEs) leading to discontinuation were recorded.

Results: A total of 251 patients included (mean age, 46 years; 59.4%, men; 64.5% with at least 1 atopic comorbidity; mean time from AD diagnosis, 14.5 years). Of these, 196 (78.1%) had been on ≥ 2 systemic therapies before starting dupilumab. Baseline EASI and IGA values averaged 27.9 and 4.0, respectively. Persistence rates were 90%, 80%, 78%, and 73% after 1, 2, 3, and 4-years, respectively. By 16 weeks, 47.8% and 54.7% of patients achieved EASI ≤ 3 or IGA ≤ 1, increasing to 76.3% and 77.2% by 52 weeks, and reaching 90.9% in the group followed for > 3 years. A total of 38 patients (13.5%) discontinued dupilumab, mainly due to inefficacy (5.6%) and AEs (1.2%).

Conclusion: Dupilumab effectively reduced AD severity within the first few weeks, with most patients achieving mild/minimal disease activity or complete clearance by year 1. The observed safety profile was consistent with known data. High persistence rates up to 4-years suggest satisfaction with dupilumab long-term safety and efficacy profilen in managing moderate-to-severe AD.

Background/objective: There is no consensus on the response rates of secukinumab, as findings from phase III trials differ from those reported in clinical-practice studies. This study aimed to assess the mid-term safety and efficacy profile of secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS).

Methods: This retrospective, multicenter study included patients with moderate-to-severe HS treated with secukinumab (300 mg every four weeks) between 2020 and 2024. Eligible patients were aged ≥ 18 years, with a clinical diagnosis of moderate-to-severe HS, and a minimum follow-up of 24 weeks. Key exclusions included patients treated with nonstandard secukinumab dosing regimens or those with insufficient clinical data. The primary endpoints were achievement of HiSCR50 (≥ 50% reduction in the combined count of nodules and abscesses) at weeks 16 and 24). Secondary endpoints included achieving a ≥ 55% reduction in the International HS Severity Score (IHS4-55) and adverse events.

Results: A total of 263 patients (49.4%, women; 50.6%, men; mean age, 41.8 ± 13.2 years) were included. The most common HS phenotype was mixed (49.4%), and 55.1% had Hurley stage III disease. At weeks 16 and 24, a total of 57.4% and 63.6% of patients achieved HiSCR50, respectively. The mean IHS4 score dropped significantly from 16.7 ± 10.0 at baseline to 7.6 ± 5.6 at week 24 (p < 0.0001). At weeks 16 and 24, 52% and 56% of patients achieved an IHS4-55 response. Secukinumab was discontinued in 14.5% of patients because of lack of efficacy or adverse events.

Conclusions: Secukinumab demonstrated a significant safety and efficacy profile for patients with moderate-to-severe in a real-world setting, with better outcomes than those reported in earlier clinical trials. Response evaluation at both week 16 and 24 is crucial due to variations in treatment effectiveness.