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Effect of Dupilumab on Sexual Desire in Adult Patients with Moderate to Severe Atopic Dermatitis.

ABSTRACT: Background: Atopic dermatitis (AD) is a chronic inflammatory condition causing itching skin, with a significant psychosocial impact on patients and relatives. AD affects 15 to 30% of children and 2 to 10% of adults. AD significantly affects patients' quality of life (QoL) given the chronicity and symptoms of the disease. Most AD patients have reported that the disease affects daily life, resulting in limited social contact and a strong impact on sexual health (SH), especially in moderate-severe cases. Materials and methods: We performed a prospective study from 1 May 2020 to 1 May 2022; the aim of the study was to evaluate the impact of moderate to severe AD on sexual desire, seduction, and partner relationships, and describe how it varies following dupilumab therapy. We used the Sexual Desire Inventory-2 (SDI-2), a validated instrument consisting of 14 items; moreover, we used a second questionnaire with eight items, an unvalidated instrument created specifically for this study, to obtain the assessment of the influence of AD on the body image, sexuality, and self-perception of those affected. Results and Conclusions: The impact of AD on sexual desire assessed using SDI-2 showed a significant improvement in both sexes during dupilumab treatment from the baseline to W4 and W16. Similar results were obtained with our questionnaire.

SUBMITTER: Napolitano M

PROVIDER: S-EPMC9782472 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Effect of Dupilumab on Sexual Desire in Adult Patients with Moderate to Severe Atopic Dermatitis.

Napolitano Maddalena M Fabbrocini Gabriella G Kastl Sara S Battista Teresa T Di Guida Adriana A Martora Fabrizio F Picone Vincenzo V Ventura Virginia V Patruno Cataldo C

Medicina (Kaunas, Lithuania) 20221123 12

<i>Background</i>: Atopic dermatitis (AD) is a chronic inflammatory condition causing itching skin, with a significant psychosocial impact on patients and relatives. AD affects 15 to 30% of children and 2 to 10% of adults. AD significantly affects patients' quality of life (QoL) given the chronicity and symptoms of the disease. Most AD patients have reported that the disease affects daily life, resulting in limited social contact and a strong impact on sexual health (SH), especially in moderate- ...[more]

PMID: 36556910

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Project description:BackgroundDevelopment of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to monoclonal antibodies may adversely impact pharmacokinetics, efficacy, and/or safety.ObjectiveTo describe incidence, titer, and persistence of dupilumab ADAs and NAbs, and their effects on pharmacokinetics, efficacy, and safety in patients with atopic dermatitis (AD).MethodsThis analysis included seven phase 3 randomized, placebo-controlled (N=2,992) and two long-term open-label extension (N=2,287) trials of subcutaneous dupilumab in adults and pediatric patients with moderate-to-severe AD. ADA, NAb, and dupilumab concentration in serum were assessed using validated immunoassays. ADA impacts on efficacy (EASI) and safety were assessed.ResultsTreatment-emergent ADAs were observed in up to 8.6% (aged ≥18 years), 16.0% (12-17 years), 5.3% (6-11 years), and 2.0% (6 months to 5 years) dupilumab-treated patients. Among dupilumab-treated patients, ≤3.7% had persistent responses, <1% had high titers (≥10,000), and ≤5.1% were NAb-positive. NAbs were more common in patients with moderate- and high-titer ADA responses. High-titer ADAs, while infrequent, were the variable most associated with lower dupilumab concentrations in serum and loss of efficacy, independent of NAb status. Efficacy was generally similar in ADA-positive and -negative patients. For most patients with high- or moderate-titer ADAs, titers decreased and efficacy improved over time with continued dupilumab treatment. ADA-positive and -negative patients had similar incidences of treatment-emergent and serious treatment-emergent adverse events. One patient with high-titer ADAs developed serum sickness.ConclusionIn patients with AD, ADAs and NAbs had minimal impact on dupilumab concentration, efficacy, and safety, except for high-titer ADAs in a small number of patients.Clinical trial registrationClinicalTrials.gov, identifiers (NCT02277743, NCT02277769, NCT02260986, NCT02395133, NCT01949311, NCT03054428, NCT03345914, NCT02612454, and NCT03346434).

Project description:ImportanceModerate to severe atopic dermatitis (AD) is a chronic inflammatory skin disease that often requires continuous long-term systemic management. Long-term safety and efficacy data for treatment options are critically important.ObjectiveTo assess the safety and efficacy of dupilumab treatment for up to 5 years in adults with moderate to severe AD.Design, setting, and participantsThe 5-year LIBERTY AD open-label extension study was conducted from September 2013 to June 2022 at 550 sites in 28 countries. The study enrolled adult patients with moderate to severe AD who had participated in previous dupilumab clinical trials. Data were analyzed from August 2022 to February 2023.ExposuresAt enrollment, patients initiated a regimen of subcutaneous dupilumab, 200 mg, weekly (400-mg loading dose). The regimen was amended in June 2014 to dupilumab, 300 mg, weekly (600-mg loading dose) based on a dose-ranging study and again in November 2019 to dupilumab, 300 mg, every 2 weeks to align with the regulatory regimen approvals.Main outcomes and measuresThe primary end points were the incidence and rate of treatment-emergent adverse events (TEAEs). Key secondary end points included incidence and rate of serious TEAEs and adverse events of special interest, proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear), and proportion of patients with 75% or more improvement in the Eczema Area and Severity Index (EASI) from the parent study baseline.ResultsA total of 2677 patients were enrolled and treated in the open-label extension study; 1611 (60.2%) were male, and the mean (SD) age was 39.2 (13.4) years. A total of 334 patients (12.5%) completed treatment up to week 260. The most common reasons for withdrawal were due to regulatory approval of dupilumab in compliance with the study protocol (810 of 1380 [58.7%]), patient withdrawal (248 of 1380 [18.0%]), and adverse events (116 of 1380 [8.4%]). Exposure-adjusted rates of TEAEs were generally stable or declined throughout the study. Common TEAEs (incidence of 5% or greater) included nasopharyngitis, worsening AD, upper respiratory tract infection, conjunctivitis, conjunctivitis allergic, headache, oral herpes, and injection-site reaction. At week 260, 220 of 326 patients (67.5%) achieved an IGA score of 0 or 1 and 288 of 324 (88.9%) achieved 75% or greater improvement in the EASI. The mean (SD) EASI score was 16.39 (14.60) at baseline and 2.75 (5.62) at end of study.Conclusions and relevanceIn this study, there was sustained safety and efficacy of continuous long-term dupilumab treatment for adults with moderate to severe AD.

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Effect of Dupilumab on Sexual Desire in Adult Patients with Moderate to Severe Atopic Dermatitis.

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Effect of Dupilumab on Sexual Desire in Adult Patients with Moderate to Severe Atopic Dermatitis.

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