Safety and Efficacy of Tacrolimus Ointment 0.1% (Protopic™) in Atopic Dermatitis: A Canadian Open-Label Multicenter Study

2004 ◽  
Vol 8 (4) ◽  
pp. 213-219 ◽  
Author(s):  
Jerry Tan ◽  
Richard Langley
Keyword(s):  
Atopic Dermatitis ◽  
Severe Disease ◽  
Multicenter Trial ◽  
Application Site ◽  
Skin Infections ◽  
Open Label ◽  
Safety And Efficacy ◽  
Topical Tacrolimus ◽  
Efficacy Parameters ◽  
Study Sites

Background: Most previously published trials of topical tacrolimus in atopic dermatitis were of relatively short duration and comprised a limited population with moderate-to-severe disease. Objective: The goal of the study was to evaluate the safety and efficacy over a 6-month period of tacrolimus 0.1% ointment in children and adults with a broader severity spectrum of atopic dermatitis. Methods: An open-label multicenter trial in patients 2 years and older was used. Primary safety and tolerability assessments included skin infection and application site adverse events. Efficacy parameters were body surface area involvement, pruritus score, and overall reponse. Results: There were 240 patients recruited at 23 study sites. Significant improvement from baseline was noted for all efficacy endpoints in both pediatric and adult patients. Skin infections occurred in 26% of patients. Burning sensation with product application, reported by 38% of patients, was transient and of mild-to-moderate severity in the majority. Conclusion: Tacrolimus 0.1% ointment was safe, well tolerated, and efficacious in treatment of atopic dermatitis in children and adults over six months.

scholarly journals A Randomized, Open-Label, Multicenter Trial of Topical Tacrolimus for the Treatment of Pruritis in Patients with Atopic Dermatitis

2012 ◽  
Vol 24 (2) ◽  
pp. 144 ◽  
Author(s):  
Satoshi Takeuchi ◽  
Hidehisa Saeki ◽  
Shoji Tokunaga ◽  
Makoto Sugaya ◽  
Hanako Ohmatsu ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Multicenter Trial ◽  
Open Label ◽  
Topical Tacrolimus

scholarly journals Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

2014 ◽  
Vol 41 (4) ◽  
pp. 629-639 ◽  
Author(s):  
Mark C. Genovese ◽  
César Pacheco Tena ◽  
Arturo Covarrubias ◽  
Gustavo Leon ◽  
Eduardo Mysler ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Severe Disease ◽  
Incidence Rates ◽  
Phase Iii ◽  
Inadequate Response ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

scholarly journals Comparison of efficacy and safety between Tacrolimus and Hydrocortisone acetate in 2-5 years old children with atopic dermatitis

2015 ◽  
Vol 10 (1) ◽  
pp. 53-58
Author(s):  
Quazi Salim Yazdi ◽  
Md Shamsul Huda ◽  
Abdul Latif Khan ◽  
Md Sayeed Hasan ◽  
Mushtaq Ahmad ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Armed Forces ◽  
Application Site ◽  
Global Evaluation ◽  
Hydrocortisone Acetate ◽  
Tacrolimus Ointment ◽  
Topical Tacrolimus ◽  
Intense Pruritus ◽  
Group 2 ◽  
Group B

Introduction: Atopic dermatitis is a recurrent inflammatory skin disease with intense pruritus as its hallmark symptom. It often follows a chronic, relapsing course. Objectives: This comparative study was done with an aim to find out the efficacy of Tacrolimus and Hydrocortisone acetate in 2-5 year old children with Atopic dermatitis. Methods: This clinical trial was carried out on two equal groups of 60 patients. “Group A” was treated with topical tacrolimus ointment (0.03%) and “group B” with hydrocortisone acetate ointment (1%). Follow up was done at week 1, 2, 4, 8 and 12 of treatment for assessment of improvement and adverse event, which was measured by ‘overall clinical improvement in the physician's global evaluation of clinical response’. Data was collected in a predesigned data collection sheet, and analysis was performed by SPSS program (Version 12). Results: Excellent, marked and moderate improvement were observed in 19 (63.3%), 9 (30.0%), and 2(6.7%) patients of tacrolimus group and 1(3.3%), 2(6.7%) and 27(90.0%) patients of hydrocortisone group respectively. Tacrolimus group had significantly better improvement than hydrocortisone group (p<0.001). Skins burning at application site were observed significantly more in tacrolimus group 8(26.7%) than in hydrocortisone group 2 (6.7%). 53 JAFMC Bangladesh. Vol 10, No 1 (June) 2014 Conclusion: The study showed tacrolimus ointment is more effective than hydrocortisone acetate in the treatment of atopic dermatitis in paediatric patients. DOI: http://dx.doi.org/10.3329/jafmc.v10i1.22924 Journal of Armed Forces Medical College Bangladesh Vol.10(1) 2014

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