6 results on '"Kenneth B. Gordon"'
Search Results
2. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis
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Linda Stein Gold, Tianyu Zhan, Gabriela Alperovich, Howard Sofen, Benjamin Lockshin, Kenneth B. Gordon, Andrew Blauvelt, Patricia C. Lee, Jerry Bagel, Ziqian Geng, and Ahmed M. Soliman
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Adult ,Moderate to severe ,medicine.medical_specialty ,Injections, Subcutaneous ,Dermatology ,Severity of Illness Index ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Autoinjector ,Psoriasis ,medicine ,Humans ,Prefilled Syringe ,030203 arthritis & rheumatology ,Plaque psoriasis ,Risankizumab ,business.industry ,Syringes ,Antibodies, Monoclonal ,Usability ,medicine.disease ,Treatment Outcome ,business - Abstract
Risankizumab is approved for treatment of moderate to severe plaque psoriasis. Availability of a patient-controlled single self-injection of risankizumab may improve adherence and long-term management of psoriasis.To investigate efficacy, safety, and usability of a new risankizumab 150 mg/mL formulation administered as a single subcutaneous injection via prefilled syringe (PFS) or autoinjector (AI).Efficacy, safety, usability, and acceptability of risankizumab 150 mg/mL PFS or AI were investigated in adults with moderate to severe psoriasis in two phase 3 studies. Study 1 was a multicenter, randomized, double-blinded, placebo-controlled study that investigated 150 mg/mL risankizumab PFS; study 2 was a multicenter, single-arm, open-label study that investigated 150 mg/mL risankizumab AI.At week 16, risankizumab 150 mg/mL demonstrated efficacy vs. placebo (Psoriasis Area and Severity Index ≥90% improvement (PASI 90), 62.9% vs. 3.8%; static Physician Global Assessment (sPGA) 0/1, 78.1% vs. 9.6%; bothThe efficacy, safety, and usability of 150 mg/mL risankizumab delivered as a single PFS or AI injection support use of this new formulation in patients with moderate to severe plaque psoriasis.NCT03875482 and NCT0387508.
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- 2021
3. Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis
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Alan M. Mendelsohn, Yang Zhao, Simon Lowry, Alan Menter, Jeffrey J. Crowley, Stephen J. Rozzo, J. Parno, Stephen K. Tyring, Boni E. Elewski, and Kenneth B. Gordon
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Adult ,Male ,Moderate to severe ,medicine.medical_specialty ,medicine.drug_class ,Tildrakizumab ,Dermatology ,Antibodies, Monoclonal, Humanized ,Monoclonal antibody ,Interleukin-23 ,Severity of Illness Index ,Etanercept ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Psoriasis ,medicine ,Humans ,In patient ,030203 arthritis & rheumatology ,Plaque psoriasis ,business.industry ,Middle Aged ,medicine.disease ,Treatment Outcome ,Female ,business ,Immunosuppressive Agents - Abstract
Background: Tildrakizumab is a high-affinity, humanized, IgG1 κ, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis.Objectives: This analysis examined whether ...
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- 2019
4. The experience of pain and redness in patients with moderate to severe plaque psoriasis
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Donald M. Bushnell, Hema N. Viswanathan, Mona L. Martin, Dina Chau, Lionel Pinto, and Kenneth B. Gordon
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Adult ,Male ,Washington ,Moderate to severe ,medicine.medical_specialty ,Colorado ,Georgia ,Pain ,severity ,Signs and symptoms ,Dermatology ,Severity of Illness Index ,California ,Cognition ,Psoriasis Symptom Inventory ,Surveys and Questionnaires ,Psoriasis ,medicine ,Humans ,In patient ,Qualitative Research ,Aged ,Skin ,Plaque psoriasis ,business.industry ,Psoriasis signs and symptoms ,Middle Aged ,medicine.disease ,Arthralgia ,Quality of Life ,Physical therapy ,Female ,Self Report ,Patient Participation ,business ,Skin lesion ,Qualitative research - Abstract
Introduction: The Psoriasis Symptom Inventory is a patient-reported outcome instrument that assesses severity of psoriasis signs and symptoms. In early qualitative research, patients reported pain related to psoriasis skin lesions and redness of affected areas of skin as key symptoms. Methods: Individual concept elicitation interviews and cognitive interviews were conducted in adults with moderate to severe plaque psoriasis. Interviews were audio-recorded and transcribed. Concepts were identified, coded and grouped by similar content using Atlas.ti software. Results were evaluated using qualitative research methods. Results: Of 30 patients recruited, 20 patients participated in concept elicitation interviews and 10 participated in cognitive interviews. Concept codes for skin pain and descriptions of color comprised 11% and 15%, respectively, of all symptom-related expressions. Of 90 pain-related expressions, 22 were about pain related to unconscious scratching and 68 were about pain from the psoriasis lesions. Of 199 color-related expressions, 72 were about red or reddish lesion color. Patients with darker skin tones were found to interpret redness consistently. Discussion: These results provide further support to content validity of pain and redness concepts in the Psoriasis Symptom Inventory. Conclusions: Symptoms of skin pain and redness are highly relevant to patients with psoriasis.
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- 2015
5. Impact of adalimumab treatment on patient‐reported outcomes: Results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis
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Craig L. Leonardi, Alan Menter, Richard G. Langley, Dennis A. Revicki, Mary Kaye Willian, Alexa B. Kimball, Martin M. Okun, Kenneth B. Gordon, and Miriam Kimel
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Adult ,Male ,medicine.medical_specialty ,Randomization ,Anti-Inflammatory Agents ,Dermatology ,Antibodies, Monoclonal, Humanized ,Placebo ,law.invention ,Double-Blind Method ,Quality of life ,Randomized controlled trial ,law ,Surveys and Questionnaires ,Multicenter trial ,Internal medicine ,Psoriasis ,Adalimumab ,Health Status Indicators ,Humans ,Medicine ,Skin ,Analysis of Variance ,Tumor Necrosis Factor-alpha ,business.industry ,Antibodies, Monoclonal ,Dermatology Life Quality Index ,Middle Aged ,medicine.disease ,humanities ,Treatment Outcome ,Quality of Life ,Physical therapy ,Female ,business ,medicine.drug - Abstract
The effect of adalimumab on patient-reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16-week, double-blind period of a 52-week, Phase III, multicenter trial.Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF-36), the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP), and several patient-rated symptom scales.The adalimumab-treated group reported significantly greater improvements in DLQI total score (p0.001), SF-36 Physical Component Summary score (p0.001), and Mental Component Summary score (p0.001) compared with the placebo-treated group over 16 weeks. Significant differences, favoring adalimumab, were also seen for the DLQI subscale scores (p0.001); SF-36 scale scores (p0.001); WPAI-SHP work impairment (p0.001), activity limitation (p0.001), and overall work impairment scores (p0.001); patient's global assessment of disease severity (p0.001), psoriasis pain (p0.001), and psoriasis-related pruritus (p = 0.002).Adalimumab was efficacious in improving dermatology-specific and general health-related quality of life, work and activity limitations, and psoriasis-related symptoms in patients with moderate to severe psoriasis over a 16-week period.
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- 2007
6. Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy
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Alice B. Gottlieb, Angelika Jahreis, Andrea Wang, Ralph Zitnik, Kenneth B. Gordon, Boni E. Elewski, and Craig L. Leonardi
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,medicine.medical_treatment ,macromolecular substances ,Dermatology ,Gastroenterology ,Receptors, Tumor Necrosis Factor ,Etanercept ,Double-Blind Method ,Psoriasis ,Internal medicine ,medicine ,Humans ,Immunologic Factors ,Etanercept therapy ,Chemotherapy ,business.industry ,Antagonist ,Middle Aged ,medicine.disease ,Surgery ,Clinical trial ,Treatment Outcome ,Cytokine ,Withholding Treatment ,Immunoglobulin G ,Retreatment ,Female ,Tumor necrosis factor alpha ,business ,medicine.drug - Abstract
Although continuous therapy with the tumor necrosis factor (TNF) antagonist, etanercept, has been shown to have a favorable benefit to risk profile in the treatment of moderate to severe plaque psoriasis, it is recognized that patients and practioners may wish for intermittent treatment should life circumstances dictate.To evaluate safety and effect maintenance of etanercept retreatment in psoriasis.Results of a 24-week, randomized, placebo-controlled, double-blind study were previously reported. Patients who responded at week 24 (improved ?50% in psoriasis area and severity index [PASI]) discontinued etanercept until disease relapse (loss of ?50% of week 24 PASI improvement). Patients were retreated with blinded etanercept at the originally randomized dose: 25 mg or 50 mg twice weekly (BIW) or 25 mg once weekly; original placebo patients received 25 mg BIW for the final 12 weeks of the double-blind period and were retreated with etanercept 25 mg BIW.Psoriasis returned gradually, without untoward events, within, on average, 3 months after etanercept discontinuation. Results after 12 weeks of retreatment were similar to those achieved after the initial 12 weeks. The major limitation of this study is that it examines only one round of discontinuation/retreatment.Retreatment with etanercept was effective and well tolerated in psoriasis patients.
- Published
- 2006
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