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Author Papp, K. A. ♦ Menter, M. A. ♦ Abe, M. ♦ Elewski, B. ♦ Feldman, S. R. ♦ Gottlieb, A. B. ♦ Langley, R. ♦ Luger, T. ♦ Thaci, D. ♦ Buonanno, M. ♦ Gupta, P. ♦ Proulx, J. ♦ Lan, S. ♦ Wolk, R.
Source World Health Organization (WHO)-Global Index Medicus
Content type Text
Publisher Wiley-Blackwell (on behalf of British Association of Dermatologists)
File Format HTM / HTML
Language English
Difficulty Level Medium
Subject Domain (in DDC) Natural sciences & mathematics ♦ Chemistry & allied sciences ♦ Life sciences; biology ♦ Physiology & related subjects ♦ Biochemistry ♦ Natural history of organisms ♦ Technology ♦ Medicine & health ♦ Human physiology ♦ Pharmacology and therapeutics ♦ Diseases ♦ Manufacture for specific uses ♦ Precision instruments & other devices
Subject Domain (in MeSH) Eukaryota ♦ Organisms ♦ Skin and Connective Tissue Diseases ♦ Pathological Conditions, Signs and Symptoms ♦ Diseases ♦ Heterocyclic Compounds ♦ Chemical Actions and Uses ♦ Chemicals and Drugs ♦ Diagnosis ♦ Therapeutics ♦ Analytical, Diagnostic and Therapeutic Techniques and Equipment ♦ Physiological Phenomena ♦ Biological Sciences ♦ Persons ♦ Persons
Subject Keyword Discipline Dermatology ♦ Piperidines ♦ Administration & Dosage ♦ Protein Kinase Inhibitors ♦ Psoriasis ♦ Drug Therapy ♦ Pyrimidines ♦ Pyrroles ♦ Administration, Oral ♦ Adolescent ♦ Adult ♦ Aged ♦ Chronic Disease ♦ Dose-response Relationship, Drug ♦ Drug Administration Schedule ♦ Female ♦ Humans ♦ Male ♦ Middle Aged ♦ Adverse Effects ♦ Treatment Outcome ♦ Young Adult ♦ Clinical Trial, Phase Iii ♦ Journal Article ♦ Multicenter Study ♦ Randomized Controlled Trial ♦ Research Support, Non-u.s. Gov't
Abstract BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. OBJECTIVES: To determine the 16-week efficacy and safety of two oral tofacitinib doses vs. placebo in patients with moderate-to-severe chronic plaque psoriasis. METHODS: Patients in two similarly designed phase III studies (OPT Pivotal 1, NCT01276639, n = 901; OPT Pivotal 2, NCT01309737, n = 960) were initially randomized 2 : 2 : 1 to tofacitinib 10 or 5 mg or placebo, twice daily. Coprimary efficacy end points (week 16) included the proportion of patients achieving Physician's Global Assessment (PGA) of 'clear' or 'almost clear' (PGA response) and the proportion achieving ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75). RESULTS: Across OPT Pivotal 1 and OPT Pivotal 2, 745 patients received tofacitinib 5 mg, 741 received tofacitinib 10 mg and 373 received placebo. At week 16, a greater proportion of patients achieved PGA responses with tofacitinib 5 and 10 mg twice daily vs. placebo (OPT Pivotal 1, 41·9% and 59·2% vs. 9·0%; OPT Pivotal 2, 46·0% and 59·1% vs. 10·9%; all P < 0·001). Higher PASI 75 rates were observed with tofacitinib vs. placebo (OPT Pivotal 1, 39·9%, 59·2% and 6·2%, respectively, for tofacitinib 5 and 10 mg twice daily and placebo; OPT Pivotal 2, 46·0%, 59·6% and 11·4%; all P < 0·001 vs. placebo). Adverse event (AE) rates appeared generally similar across groups; rates of serious AEs, infections, malignancies and discontinuations due to AEs were low. Twelve patients reported herpes zoster across the tofacitinib treatment groups in both studies vs. none in the respective placebo groups. The most common AE across groups was nasopharyngitis. CONCLUSIONS: Oral tofacitinib demonstrated significant efficacy vs. placebo during the initial 16 weeks of treatment in patients with moderate-to-severe psoriasis. Safety findings were consistent with prior studies.
Description Country affiliation: Canada
Author Affiliation: Papp KA ( Probity Medical Research and K Papp Clinical Research Inc., 135 Union Street East, Waterloo, ON, N2J 1C4, Canada.); Menter MA ( Baylor Research Institute, Dallas, TX, U.S.A.); Abe M ( Gunma University Hospital, Maebashi, Gunma, Japan.); Elewski B ( University of Alabama, Tuscaloosa, AL, U.S.A.); Feldman SR ( Wake Forest Baptist Health, Winston-Salem, NC, U.S.A.); Gottlieb AB ( Tufts Medical Center, Boston, MA, U.S.A.); Langley R ( Dalhousie University, Halifax, NS, Canada.); Luger T ( University of Münster, Münster, Germany.); Thaci D ( University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.); Buonanno M ( Pfizer Inc., Groton, CT, U.S.A.); Gupta P ( Pfizer Inc., Groton, CT, U.S.A.); Proulx J ( Pfizer Inc., Groton, CT, U.S.A.); Lan S ( Pfizer Inc., Groton, CT, U.S.A.); Wolk R ( Pfizer Inc., Groton, CT, U.S.A.)
ISSN 00070963
Educational Role Student ♦ Teacher
Age Range above 22 year
Educational Use Reading ♦ Research ♦ Self Learning
Interactivity Type Expositive
Education Level UG and PG
Learning Resource Type Article
Publisher Date 2015-10-01
Publisher Place Great Britain (UK)
e-ISSN 13652133
Journal British Journal of Dermatology
Volume Number 173
Issue Number 4


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Source: WHO-Global Index Medicus