Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, efficacy - 11/05/12
Tacrolimus Ointment Study Group**
Abstract |
A total of 632 adults with atopic dermatitis applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks in two randomized, double-blind studies. This report focuses on the efficacy of tacrolimus ointment in these studies. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. Evaluations included a physician's global evaluation of clinical response, %BSA affected, individual signs of atopic dermatitis, the Eczema Area and Severity Index (EASI) score, and the patient's assessment of pruritus. A 90% or greater improvement from baseline in disease status was observed for 6.6%, 27.5%, and 36.8% of patients in the vehicle, 0.03% tacrolimus ointment, and 0.1% tacrolimus ointment groups, respectively (P < .001), and 50% or better improvement was observed for 19.8%, 61.6%, and 72.7% of patients, respectively. Tacrolimus ointment-treated patients showed significantly greater improvement than vehicle-treated patients for all efficacy parameters evaluated, including the %BSA affected, the total score and individual scores for signs of atopic dermatitis, the patient's assessment of pruritus, and EASI score. The 0.1% concentration was more effective than the 0.03% concentration, particularly in patients with severe disease and/or extensive BSA involvement at baseline and in African Americans. Tacrolimus ointment is an effective therapy for the treatment of adult patients with atopic dermatitis on all skin regions including the head and neck. (J Am Acad Dermatol 2001;44:S28-38.)
Le texte complet de cet article est disponible en PDF.Abbreviations : BSA:, CMH:, EASI:
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 Hanifin has received grant support from Fujisawa. Dr Ling has been a consultant, received grant support, and been on the speaker's bureau of Fujisawa Healthcare, Inc. Dr Langley has received grant support and been a consultant for Fujisawa. Dr Breneman's institution has received grant support from Fujisawa. Dr Rafal's institution has received grant support from Fujisawa. |
| Reprint requests: Jon M. Hanifin, MD, Oregon Health Sciences University, Department of Dermatology, Mail Code L468, 3181 SW Sam Jackson Park Rd, Portland, OR 97201. |
| ♢ | *Dr Ling is currently at MedaPhase. |
| ♢♢ | Additional members of the Tacrolimus Ointment Study Group: Melanie Appell, MD, Hill Top Research, Inc, Birmingham, Ala; 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; Alan Fleischer, MD, Wake Forest University School of Medicine, Winston-Salem, NC; Bernard S. Goffe, MD, Novum-Seattle, Seattle, Wash; J. John Goodman, MD, Hill Top Research, West Palm Beach, Fla; 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; Ira D. Lawrence, MD, Fujisawa Healthcare, Inc, Deerfield, Ill; Donald Y. Leung, MD, PhD, National Jewish Medical & Research Center, Denver, Colo; 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; Eugene Monroe, MD, Advanced HealthCare, SC, Milwaukee, Wis; 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, Eastern Virginia Medical School, 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; Sharon S. Raimer, MD, University of Texas Medical Branch, Galveston, Tex; Yoichi Satoi, Fujisawa Healthcare, Inc, Deerfield, Ill; Ronald Savin, MD, Savin Dermatology Center, New Haven, Conn; 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; Nicholas Soter, MD, New York University Medical Center, New York, NY; 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; Guy F. Webster, MD, PhD, Jefferson Medical College, Philadelphia, Pa; Gerald D. Weinstein, MD, University of California at Irvine, Irvine, Calif; David G. Wilson, MD, The Education and Research Foundation, Inc, Lynchburg, Va; and Suzanne Zheng, Fujisawa Healthcare, Inc, Deerfield, Ill. |
| ♦ | J Am Acad Dermatol 2001;44:S28-38. |
Vol 44 - N° 1S
P. S28-S38 - janvier 2001 Retour au numéro
Article précédent
- Nonclinical and early clinical development of tacrolimus ointment for the treatment of atopic dermatitis
- Ihor Bekersky, William Fitzsimmons, Atsushi Tanase, Rochelle M. Mahera, Ellen Hodosh, Ira Lawrence
- Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, safety
- Nicholas A. Soter, Alan B. Fleischer, Guy F. Webster, Eugene Monroe, Ira Lawrence, Tacrolimus Ointment Study Group*
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