Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil.

Background: Psoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit.

Objective: The authors assessed the efficacy and safety of risankizumab compared with methotrexate in adults with moderate-to-severe plaque psoriasis.

Cedirogant in adults with psoriasis: a phase II, randomized, placebo-controlled clinical trial.

Background: Dysregulated interleukin (IL)-17/IL-23 signalling contributes to psoriasis pathogenesis. Cedirogant is an inverse agonist of nuclear receptor ROR-gamma isoform 2 (RORyt), a key transcription factor responsible for IL-17 synthesis and a regulator of the T helper 17 cell lineage programme.

Objectives: To evaluate the efficacy and safety of cedirogant to treat moderate-to-severe psoriasis.

Efficacy of long-term risankizumab treatment for moderate-to-severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial).

Background: Psoriasis is an inflammatory skin disease that impacts a heterogeneous group of patients and can have multiple clinical manifestations. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis.

Objectives: To evaluate the long-term efficacy of risankizumab according to baseline patient characteristics, and for the treatment of high-impact disease manifestations (nail, scalp and palmoplantar psoriasis), through 256 weeks of continuous treatment in the phase 3 LIMMitless study.

Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.

Background: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy.

Objective: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis.

Methods: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies.

Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up).

Background: Characterization of upadacitinib use and switching from dupilumab to upadacitinib among patients with moderate-to-severe atopic dermatitis (AD) is needed.

Objective: To evaluate the long-term safety and efficacy of continuous upadacitinib 30 mg and switching to upadacitinib after 24 weeks of dupilumab.

Methods: Adults who completed the phase 3b clinical trial of oral upadacitinib 30 mg vs injectable dupilumab 300 mg (Heads Up) and entered a 52-week open-label extension (OLE) (NCT04195698) were included.

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation.

Introduction: Risankizumab has demonstrated efficacy and safety in phase 3 studies in patients with moderate to severe plaque psoriasis. This randomized clinical trial assessed the efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis in the Russian Federation.

Methods: Patients with moderate to severe plaque psoriasis were randomized 4:1 to 16 weeks of double-blind treatment with risankizumab 150 mg or placebo (period A; dosing at baseline and week 4) followed by an open-label extension (period B) during which all patients received risankizumab 150 mg at weeks 16, 28, and 40 and were followed up to week 52.

Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study.

Introduction: Patients with moderate-to-severe plaque psoriasis who experience poor clinical outcomes, including patients with obesity or prior treatment, need improved treatment options. Risankizumab specifically inhibits interleukin 23 and has demonstrated superior efficacy in active-comparator studies in patients with moderate-to-severe plaque psoriasis. We compared the efficacy of risankizumab with that of secukinumab across patient subgroups.

Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.

Importance: Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease with an unmet need for treatments that provide rapid and high levels of skin clearance and itch improvement.

Objective: To assess the safety and efficacy of upadacitinib vs dupilumab in adults with moderate-to-severe AD.

Design, Setting, And Participants: Heads Up was a 24-week, head-to-head, phase 3b, multicenter, randomized, double-blinded, double-dummy, active-controlled clinical trial comparing the safety and efficacy of upadacitinib with dupilumab among 692 adults with moderate-to-severe AD who were candidates for systemic therapy.

Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab.

Objective: To examine the concurrent validity and discrimination of criteria for modified minimal disease activity (MDA) in peripheral spondyloarthritis (SpA) following filter principles of Outcome Measures in Rheumatology (OMERACT) and to determine predictors of modified MDA response.

Methods: Four modified MDA versions were derived in the ABILITY-2 study using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index or the Leeds Enthesitis Index (LEI) while excluding psoriasis. To assess concurrent validity, modified MDA versions were correlated with Peripheral Spondyloarthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score showing inactive disease (ASDAS ID), and physician global assessment of disease activity.

Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial.

Importance: Risankizumab selectively inhibits interleukin 23, a cytokine that contributes to psoriatic inflammation.

Objective: To evaluate the efficacy and safety of risankizumab vs placebo and continuous treatment vs withdrawal in adults with moderate to severe plaque psoriasis.

Design, Setting, And Participants: Multinational, phase 3, randomized, double-blind, placebo-controlled trial conducted from March 6, 2016, to July 26, 2018.

Sample size considerations for comparing dynamic treatment regimens in a sequential multiple-assignment randomized trial with a continuous longitudinal outcome.

Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignment randomized trial is a research tool which allows for the construction of effective dynamic treatment regimens.

Power analysis in a SMART design: sample size estimation for determining the best embedded dynamic treatment regime.

Sequential, multiple assignment, randomized trial (SMART) designs have become increasingly popular in the field of precision medicine by providing a means for comparing more than two sequences of treatments tailored to the individual patient, i.e., dynamic treatment regime (DTR).

Identifying a set that contains the best dynamic treatment regimes.

A dynamic treatment regime (DTR) is a treatment design that seeks to accommodate patient heterogeneity in response to treatment. DTRs can be operationalized by a sequence of decision rules that map patient information to treatment options at specific decision points. The sequential, multiple assignment, randomized trial (SMART) is a trial design that was developed specifically for the purpose of obtaining data that informs the construction of good (i.