A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis - 24/08/11
, Mark Boguniewicz, MD b, Eric Carter, MD c, Michael Jarratt, MD d, David Pariser, MD e, f, Dan Stewart, DO g, Matt Stiller, MD c, Eduardo Tschen, MD, MBA h, Katie Chon, RPh i, Steve Wisseh, DrPH i, Beatrice Abrams, PhD i
Reprint requests: Steven Kempers, MD, Minnesota Clinical Study Center, 7205 University Avenue NE, Fridley, MN 55432-3133, USA.Fridley, Minnesota; Denver, Colorado; New York, New York; Austin, Texas; Norfolk, Virginia; Clinton Township, Michigan; Albuquerque, New Mexico; and East Hanover, New Jersey
Abstract |
Objective |
To evaluate pimecrolimus cream 1% and tacrolimus ointment 0.03% in pediatric patients with moderate atopic dermatitis (AD).
Methods |
141 patients (aged 2-17 years) were randomized to treatment with pimecrolimus cream 1% (n=71) or tacrolimus ointment 0.03% (n=70) twice daily for 6 weeks.
Results |
At day 4, local, application-site reactions were less common and of shorter duration with pimecrolimus than with tacrolimus. Incidence of erythema/irritation was 8% (6/71) with pimecrolimus compared with 19% (13/70) with tacrolimus (P=.039). Fewer patients receiving pimecrolimus (0%, 0/6) experienced erythema/irritation lasting >30 minutes, compared with those receiving tacrolimus (85%, 11/13; P < .001). Fewer patients reported itching with pimecrolimus (8%; 6/71) than with tacrolimus (20%; 14/70; P=.073). Incidence of warmth, stinging, and burning was similar in both groups; however, reactions lasting >30 minutes were fewer with pimecrolimus (0%, 0/14) than with tacrolimus (67%, 8/12; P < .001). More patients receiving pimecrolimus rated ease of application as ‘excellent’ or ‘very good’, compared with tacrolimus (76% vs 59%, respectively; P < .020). Efficacy was similar in both groups at day 43. Both treatments were generally well tolerated with no unexpected adverse events.
Conclusion |
Pimecrolimus cream 1% had better formulation attributes and local tolerability than tacrolimus ointment 0.03% while providing similar efficacy and overall safety in pediatric patients with moderate AD.
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 | This study was sponsored by Novartis Pharmaceuticals Corporation. Disclosure: S. Kempers: Grant/Research support from Novartis, 3M, Abbott Laboratories, Allergan, Altana, Atrix, Barrier Therapeutics, Berlex, Bertek, Bristol-Myers Squibb, Clay-Park Labs, Connetics, Corixa, Dermik, Dow Pharmaceuticals, Fujisawa, Galderma, Genentech, GlaxoSmithKline, HealthPoint, Inc, IDEC, Johnson & Johnson, Medicis, Merck, Organogenesis, Paddock Labs, Parke-Davis, Penederm, Pfizer Roche, Schering-Plough, Stiefel, Wyeth-Ayerst; Consultant for Biogen, Novartis, 3M Pharmaceuticals, Genentech. M. Boguniewicz: Grant/Research support from Novartis; Lecture Honoraria from Novartis and Fujisawa. E. Carter: Grant/Research support from Novartis and Fujisawa. M. Stiller: Grant/Research support from Novartis and Fujisawa; Speaker's Bureau, participant with Novartis and Fujisawa. D. Pariser: Grant/Research support from Novartis and Fujisawa; Consultant for Novartis. E. Tschen: Grant/Research support from Novartis, Allergan, Amgen, Centocor, Dermik, Galderma, Genentech. D. Stewart: Research support from Novartis; President of Midwest Cutaneous Research, Clinton Township, MI (providing a commercial service to the pharmaceutical industry) M. Jarratt: Research support from Novartis; Partner in DermResearch, Inc, Austin, TX (providing a commercial service to the pharmaceutical industry) K. Chon, S. Wisseh and B. Abrams are employees of Novartis Pharmaceuticals Corporation, East Hanover, NJ Data from this study have been submitted as an abstract to the 62nd Annual Meeting of the AAD, Washington DC, February 6-11, 2004, and was presented as a poster at the 12th EADV Congress, Barcelona, Spain October 15-18, 2003 (JEADV 2003;17(suppl 3):183-4). |
Vol 51 - N° 4
P. 515-525 - ottobre 2004 Ritorno al numero
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