Sue Cheng

Management of Exacerbations and Rescue Therapy in the Phase 3 Myasthenia Gravis Inebilizumab Trial

Richard J. Nowak, Kimiaki Utsugisawa, Michael Benatar, Emma Ciafaloni et autres

Importance: Uncontrolled generalized myasthenia gravis (gMG) can lead to exacerbations that often warrant rescue therapy (RT) use, especially in moderate to severe cases. Inebilizumab, a monoclonal antibody that depletes cluster of differentiation 19+ B cells, demonstrated efficacy and safety in patients with …

us, jp, gb, dk (code pays fourni par la source)

Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy, Pharmacodynamics, and Immunogenicity in AChR+ Cohort (Week 52) (S14.009)

Kristen Clarkson, Kimiaki Utsugisawa, Michael Benatar, Emma Ciafaloni et autres

To evaluate the efficacy, pharmacodynamics, and immunogenicity of inebilizumab, a monoclonal antibody targeting CD19+ B-cells, in acetylcholine receptor antibody-positive (AChR+) generalized Myasthenia Gravis (gMG).

us, jp, gb, dk (code pays fourni par la source)

Results from the 32‐week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis

Joseph Frank Merola, Lyn Guenther, Charles W Lynde, Kim Alexander Papp et autres

BACKGROUND: Genital psoriasis is highly prevalent among patients with psoriasis, is often stigmatized, causes pain and discomfort and negatively impacts quality of life. Apremilast is an oral phosphodiesterase 4 inhibitor approved for treating psoriasis and has demonstrated safety and efficacy in treating …

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A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis

Richard J. Nowak, Michael G Benatar, Emma Ciafaloni, James F. Howard et autres

BACKGROUND: Autoimmune generalized myasthenia gravis is a disease that manifests with fluctuating muscle weakness. Inebilizumab is a monoclonal antibody that depletes CD19+ B cells, which are central to disease pathogenesis. METHODS: In this phase 3, double-blind, randomized, placebo-controlled trial, we enrolled participants …

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Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy and Safety Results in Patients with Generalized MG (PL5.005)

Richard J. Nowak, Kimiaki Utsugisawa, Michael G Benatar, Emma Ciafaloni et autres

To investigate the efficacy and safety of inebilizumab, a monoclonal antibody targeting CD19+ B-cells, in generalized myasthenia gravis (gMG).

us, jp, gb, dk (code pays fourni par la source)

Long-term Safety of Apremilast From a Pooled Analysis of 15 Randomized, Placebo-controlled Studies of Psoriasis, Psoriatic Arthritis, and Oral Ulcers Associated With Behçet’s Syndrome

Philip J. Mease, Gülen Hatemi, Maria M. Paris, Sue Cheng et autres

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Efficacy of Apremilast in Patients with Moderate-to-Severe Genital Psoriasis: Body Surface Area Subgroup Results from the Phase 3 DISCREET Trial

Joseph Frank Merola, Lawrence Charles Parish, Lyn Guenther, Charles W Lynde et autres

Key Takeaways• Regardless of baseline BSA, APR patients had consistent improvements in genital psoriasis symptoms and severity and quality of life at week 16• Patients with limited BSA and genital psoriasis benefited from systemic treatment with APR

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Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial

Joseph Frank Merola, Lawrence Charles Parish, Lyn Guenther, Charles W Lynde et autres

BACKGROUND: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg …

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43250 Efficacy of Apremilast in Patients With Moderate-to-Severe Plaque Psoriasis Across Weight and BMI Subgroups: Analysis From ESTEEM 1 and ESTEEM 2

Richard G B Langley, Nehal N. Mehta, Jeffrey Crowley, Cynthia Deignan et autres

ca, us (code pays fourni par la source)

40666 Long-term Safety of Apremilast From a Pooled Analysis of 15 Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Oral Ulcers Associated With Behçet’s Syndrome

Philip J. Mease, Gülen Hatemi, Maria M. Paris, Sue Cheng et autres

us, tr (code pays fourni par la source)

40665 Efficacy of Apremilast in Patients With Moderate-to-Severe Genital Psoriasis: Body Surface Area Subgroup Results From the Phase 3 DISCREET Trial

Joseph Frank Merola, Lawrence Charles Parish, Lyn Guenther, Charles W Lynde et autres

us, ca, fr, de (code pays fourni par la source)

Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behçet’s Syndrome

Philip J. Mease, Gülen Hatemi, Maria M. Paris, Sue Cheng et autres

BACKGROUND: Since US FDA approval in 2014, apremilast has consistently demonstrated a favorable benefit-risk profile in 706,585 patients (557,379 patient-years of exposure) worldwide across approved indications of plaque psoriasis, psoriatic arthritis, and Behçet's syndrome; however, long-term exposure across these indications has not …

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