Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies.

Background: Secukinumab, a fully human, monoclonal antibody targeting interleukin-17A, is approved for moderate-to-severe HS in adults. This study evaluated pharmacokinetics (PK), high-sensitivity C-reactive protein (hsCRP) changes, and safety of secukinumab over 52 weeks in SUNSHINE and SUNRISE Phase 3 trials.

Methods: An exploratory analysis of pooled Phase-3 trials evaluated serum PK and safety of secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W).

The Hidradenitis Suppurativa Symptom and Impact Diary: Development and psychometric evaluation of a novel set of patient reported outcomes for hidradenitis suppurativa.

Background: Hidradenitis suppurativa (HS) is associated with a substantial disease burden. Given the complex nature of HS-related symptoms, patient-reported outcome (PRO) measures are important to ensure that the patient experience is captured when evaluating the efficacy of treatments in clinical trials.

Objectives: To develop the Hidradenitis Suppurativa Symptom and Impact Diary (HSSID©), a novel PRO measure for use in clinical trials to assess the symptoms and impacts of HS in adult patients, and to validate its psychometric properties.

Assessing Long-Term Pain Reduction with Secukinumab in Moderate to Severe Hidradenitis Suppurativa: A Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Trials.

Introduction: Hidradenitis suppurativa (HS) is a chronic, painful skin disease associated with a high disease burden. Disease-related pain is frequently reported as the most troublesome symptom of HS. The SUNSHINE and SUNRISE phase 3 trials previously reported that secukinumab improved control of pain in patients with moderate to severe HS.

Cumulative life course impairment: Evidence for hidradenitis suppurativa.

Hidradenitis suppurativa (HS) adversely affects quality of life, education, work, relationships and mental health. The debilitating effects of HS can compound over a patient's lifetime and have lasting repercussions. The cumulative life course impairment (CLCI) model analyses the disease factors that could affect the life course trajectory of a patient, including effects on major life decisions and opportunities, such as relationships, career path, education and starting a family.

Hidradenitis Suppurativa Epidemiology.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful skin abscesses, fistulizing sinus tracts, and scarring. Despite its devastating negative effects on patients' health, quality of life, performance, and mental health, HS epidemiology is not well understood. This study aims to better characterize the epidemiology of HS, including incidence, prevalence, various demographic distributions, and risk factors.

Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study.

Background: Hidradenitis suppurativa is a disabling inflammatory skin disease.

Objective: To investigate the efficacy and safety of upadacitinib, a selective Janus kinase inhibitor.

Methods: In this phase 2, randomized, placebo-controlled, double-blind clinical trial (NCT04430855), adults with moderate-to-severe hidradenitis suppurativa were randomized 2:1 to once-daily upadacitinib 30 mg or placebo.

North American clinical practice guidelines for the medical management of hidradenitis suppurativa in special patient populations.

Background: Hidradenitis suppurativa (HS) affects different patient populations that require unique considerations in their management. However, no HS guidelines for these populations exist.

Objective: To provide evidence-based consensus recommendations for patients with HS in 7 special patient populations: (i) pregnancy, (ii) breastfeeding, (iii) pediatrics, (iv) malignancy, (v) tuberculosis infection, (vi) hepatitis B or C infection, and (vii) HIV disease.

Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial.

Background: The SUNSHINE and SUNRISE phase III trials demonstrated sustained clinical efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) through 52 weeks. Patients completing the core trials could enter a 4-year extension trial.

Objectives: To evaluate the long-term efficacy, safety/tolerability and maintenance of clinical response to secukinumab through week 104 in the extension trial.

Treatment Satisfaction in Patients with Hidradenitis Suppurativa: A Real-World Survey from the EU5 and USA.

Introduction: Hidradenitis suppurativa (HS) is a debilitating, inflammatory skin disorder. Treatment strategies in patients with HS are challenging; real-world evidence in a HS population is warranted for greater disease understanding. The objective of this analysis was to describe real-world treatment patterns and treatment satisfaction in patients with HS.

Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports.

Background And Objective: Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy.

Data wobbles in hidradenitis suppurativa clinical trials and potential contributing factors: a retrospective review.

Background: In some hidradenitis suppurativa (HS) clinical trial study arms, there is an unexpected decline in efficacy between the penultimate visit and the prespecified primary endpoint week, which we have termed a "wobble."

Objective: We aimed to establish how often study arms in HS programs wobble.

Methods: In a retrospective review, we identified HS clinical trials listed on ClinicalTrials.

Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized double-blind placebo-controlled clinical trial.

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a considerable disease burden. Existing treatment options are limited and often suboptimal; a high unmet need exists for effective targeted therapies.

Objectives: To explore the effects of spesolimab treatment in patients with HS.