Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, safety - 11/05/12
Tacrolimus Ointment Study Group*
Abstract |
In two randomized, double-blind, multicenter studies, a total of 631 adult patients with moderate to severe atopic dermatitis applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. As previously reported, these studies showed that tacrolimus ointment was superior to vehicle for all efficacy parameters measured. This report focuses on the safety of tacrolimus ointment in these studies. The most common adverse events were the sensation of skin burning, pruritus, flu-like symptoms, skin erythema, and headache. Skin burning and pruritus were more common among patients with severe or extensive disease; these events were usually brief and were resolved during the first few days of treatment. Common adverse events with a significantly higher incidence in one or both of the tacrolimus ointment groups than in the vehicle group included skin burning, flu-like symptoms, and headache. More patients in the vehicle group discontinued the study because of an adverse event than in either of the tacrolimus ointment groups. There were no notable or consistent changes in any laboratory variables. Tacrolimus was not detected in 80% of blood samples collected. Measurable concentrations of tacrolimus were transitory and were not associated with adverse events. Tacrolimus ointment is a safe therapy for the treatment of adult patients with atopic dermatitis on the face, neck, or other body regions. (J Am Acad Dermatol 2001;44:S39-46.)
Le texte complet de cet article est disponible en PDF.Abbreviations : ALT/SGPT:, AST/SGOT:, BSA:, WBC:
Plan
 | Supported by an educational grant from Fujisawa Healthcare, Inc, Deerfield, Illinois. |
| This article is part of a supplement sponsored by Fujisawa Healthcare, Inc. |
 | Dr Soter has received grant support from Fujisawa Healthcare, Inc. Dr Fleischer has received grant/research support from Fujisawa. Dr Webster has received grant/research support, been a consultant, and been on the speaker's bureau of Fujisawa. Dr Monroe's institution has received grant support from Fujisawa. Dr Lawrence is an employee of Fujisawa. |
| Reprint requests: Nicholas A. Soter, MD, New York University Medical School, Department of Dermatology, 560 First Ave, H-160, New York, NY 10016-6451. E-mail: SOTERN01@med.nyu.edu. |
| ♢ | Additional members of the Tacrolimus Ointment Study Group: Melanie Appell, MD, Hill Top Research, Inc, Birmingham, Ala; Mark Boguniewicz, MD, National Jewish Medical & Research Center, Denver, Colo; Debra Breneman, MD, University Dermatology Consultants, Inc, Cincinnati, Ohio; Michelle Chambers, MD, Hill Top Research, Inc, Columbus, Ohio; Kevin D. Cooper, MD, University Hospital of Cleveland, Cleveland, Ohio; Loretta Davis, MD, Medical College of Georgia, Augusta, Ga; Lynn Drake, MD, Oklahoma University Health Sciences Center, Oklahoma City, Okla; Frank Dunlap, MD, Hill Top Argus Research, Inc, Tucson, Ariz; Jay Erdman, Fujisawa Healthcare, Inc, Deerfield, Ill; Harold Farber, MD, Hill Top Research, Inc, Philadelphia, Pa; Virginia C. Fiedler, MD, University of Illinois Medical Center at Chicago, Chicago, Ill; Bernard S. Goffe, MD, Novum-Seattle, Seattle, Wash; J. John Goodman, MD, Hill Top Research, West Palm Beach, Fla; Jon M. Hanifin, MD, Oregon Health Sciences University, Portland, Ore; Ellen Hodosh, PhD, Fujisawa Healthcare, Inc, Deerfield, Ill; Eileen Jaracz, PharmD, Fujisawa Healthcare, Inc, Deerfield, Ill; Teri Kahn, MD, Cleveland Clinic Foundation, Cleveland, Ohio; Sewon Kang, MD, University of Michigan Medical Center, Ann Arbor, Mich; Lance Kirkegaard, MD, Puget Sound Medical Research, Tacoma, Wash; Gerald Krueger, MD, University of Utah Medical Center, Salt Lake City, Utah; Donald Y. Leung, MD, PhD, National Jewish Medical & Research Center, Denver, Colo; Mark R. Ling, MD, Emory University (currently at Medaphase), Atlanta, Ga; Jan Logan, Fujisawa Healthcare, Inc, Deerfield, Ill; Nicholas J. Lowe, MD, Clinical Research Specialists, Santa Monica, Calif; Anne W. Lucky, MD, Dermatology Research Associates, Cincinnati, Ohio; Rochelle M. Maher, Fujisawa Healthcare, Inc, Deerfield, Ill; Gailen Marshall, MD, Dermatology Research Center, Houston, Tex; Calvin O. McCall, MD, Emory University, Atlanta, Ga; Mamoru Miyake, Fujisawa Healthcare, Inc, Deerfield, Ill; Christopher Nelson, MD, Hill Top Research, Inc, St Petersburg, Fla; Khanh Nichols, MD, Mount Sinai Medical Center, New York, NY; Amy Paller, MD, Children's Memorial Hospital, Chicago, Ill; David Pariser, MD, Virginia Clinical Research, Norfolk, Va; Linda Pedersen, Fujisawa Healthcare, Inc, Deerfield, Ill; Scott Phillips, MD, University of Chicago, Chicago, Ill; Jerold Powers, MD, Hill Top Research, Inc, Scottsdale, Ariz; Elyse Rafal, MD, University Medical Center at Stony Brook, East Setauket, NY; Sharon S. Raimer, MD, University of Texas Medical Branch, Galveston, Tex; Ronald Savin, MD, Savin Dermatology Center, New Haven, Conn; Yoichi Satoi, Fujisawa Healthcare, Inc, Deerfield, Ill; J. Rodney Schmidt, MD, Puget Sound Medical Research, Tacoma, Wash; Curtis Schupbach, MD, Mecklenburg Clinical Research, Inc, Charlotte, NC; Mary P. Sheehan, MD, Novum-Pittsburgh, Pittsburgh, Pa; Daniel Shrager, MD, Fujisawa Healthcare, Inc, Deerfield, Ill; Arthur J. Sober, MD, Massachusetts General Hospital, Boston, Mass; Mary C. Spellman, MD, University of California, San Diego, La Jolla, Calif; Daniel Stewart, DO, Midwest Cutaneous Research, Clinton Township, Mich; Matthew Stiller, MD, Massachusetts General Hospital, Boston, Mass; Atsushi Tanase, PharmD, Fujisawa Pharmaceutical Ltd, Osaka, Japan; Gerald D. Weinstein, MD, University of California at Irvine, Irvine, Calif; David G. Wilson, MD, The Education and Research Foundation, Inc, Lynchburg, Va; Suzanne Zheng, Fujisawa Healthcare, Inc, Deerfield, Ill. |
| ♢♢ | J Am Acad Dermatol 2001;44:S39-46. |
Vol 44 - N° 1S
P. S39-S46 - janvier 2001 Retour au numéro
Article précédent
- Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, efficacy
- Jon M. Hanifin, Mark R. Ling, Richard Langley, Debra Breneman, Elyse Rafal, Tacrolimus Ointment Study Group**
- A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients
- Amy Paller, Lawrence F. Eichenfield, Donald Y.M. Leung, Daniel Stewart, Melanie Appell, Tacrolimus Ointment Study Group*
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