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NEW YORK Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.
A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.
Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.
In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:1517). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.
EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.
The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.
The difference became greater with time and achieved significance at week 3. DR. FLEISCHER
ELSEVIER GLOBAL MEDICAL NEWS
NEW YORK Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.
A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.
Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.
In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:1517). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.
EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.
The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.
The difference became greater with time and achieved significance at week 3. DR. FLEISCHER
ELSEVIER GLOBAL MEDICAL NEWS
NEW YORK Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.
A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.
Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.
In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:1517). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.
EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.
The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.
The difference became greater with time and achieved significance at week 3. DR. FLEISCHER
ELSEVIER GLOBAL MEDICAL NEWS