Class of 2006 Abstract / Objectives: To evaluate the comparative efficacies of Tacrolimus and Pimecrolimus for the treatment of Keratoconjunctivitis Sicca (KCS), Pannus, and other autoimmune related ophthalmological disorders. Methods: A descriptive retrospective study of clinical data obtained through two separate veterinary studies. The improvement in Schirmer Tear Test (STT) between the Tacrolimus group and Pimecrolimus group is compared. Results: There were 27 canines in the Tacrolimus group, with a total of 50 affected eyes. The Pimecrolimus group had 14 total canines, but tear production was measured in only 8, for a total of 16 affected eyes. At baseline, there was no significant difference in tear production between the two groups. At first and second follow up, and in both eyes, Tacrolimus produced a significantly greater increase in tear production than Pimecrolimus (p=0.0093 and p=0.0292 respectively for the right eye first and second follow up; p=0.0425 and p=0.0065 respectively for the left eye first and second follow up). Conclusions: Treatment with Tacrolimus produced a greater increase in tear production that Pimecrolimus in canines with autoimmune keratitis.

Background: Pimecrolimus cream 1% is a non-steroid, selective inflammatory cytokine inhibitor indicated for atopic dermatitis (AD). Objective: To compare the safety and efficacy of pimecrolimus cream 1%-based treatment versus conventional therapy in adults with moderate AD. Methods: Patients were randomized to receive pimecrolimus cream 1% (n = 62) or vehicle (n = 68) at the first signs/symptoms of AD, for 24 weeks as required. A moderately potent topical corticosteroid (prednicarbate 0.25% cream) was allowed in both groups to treat flares. Results: Corticosteroids were required on fewer days in the pimecrolimus group, compared with the vehicle group (9.7 vs. 37.8%, p < 0.001). Furthermore, 59.7% of pimecrolimus-treated patients experienced no flares during the study period, compared with 22.1% of vehicle-treated patients (p < 0.001). Pimecrolimus cream 1% was well tolerated throughout the study. Conclusion: For adults with moderate AD, pimecrolimus cream 1% is well tolerated, reduces the incidence of flares, reduces/eliminates corticosteroid use, improves long-term disease control and enhances the patients’ quality of life. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

A dermatite seborrÃica (DS) Ã uma das doenÃas mais comum entre os pacientes portadores do vÃrus HIV afetando entre 40 a 80% dos pacientes com AIDS e 20 a 40% dos pacientes soropositivos para o vÃrus HIV. Com o intuito de avaliar a eficÃcia terapÃutica e seguranÃa do pimecrolimo creme 1% na DS de face de pacientes HIV-positivos, foi realizado estudo fase II. Inicialmente quatro pacientes (Grupo A) portadores de DS leve a severa foram tratados com o pimecrolimo duas vezes por dia por 7 dias e o segundo grupo (Grupo B) vinte e um pacientes, foram tratados com pimecrolimo duas vezes por dia por 14 dias. Em seguida o tratamento era descontinuado e os pacientes foram acompanhados por mais 5 semanas. A avaliaÃÃo das lesÃes foi realizada no dia inicial, 7Â, 14Â, 21Â, 35Â e 49Â dia utilizando-se uma escala com pontuaÃÃo de zero a quatro para cada parÃmetro avaliado (eritema, descamaÃÃo, ardor, prurido, infiltraÃÃo/papulaÃÃo, escoriaÃÃo, liquenificaÃÃo), e tambÃm por meio de fotografia digital. Obteve-se importante melhora em todos os parÃmetros clÃnicos avaliados no 7Â dia; no 14Â dia 90% dos pacientes apresentavam-se livres de sinais. O eritema e a descamaÃÃo apresentaram recidiva em aproximadamente 50% dos pacientes no 35Â dia do estudo, mas o quadro clÃnico era menos intenso que o quadro clÃnico inicial. Todos os pacientes responderam a terapÃutica independente do seu âstatusâ imunolÃgico. O pimecrolimo creme 1% representa uma nova, atrativa e eficaz, opÃÃo terapÃutica para o tratamento da DS de face em pacientes HIV-positivos. / Seborrheic dermatitis (SD) is a one of the most common dermatosis in HIV-positive patients affecting between 40 to 80% of AIDS patients and 20 to 40% of HIV-positive patients. To investigate efficacy and safety of pimecrolimus cream 1% in HIV-positive patients with facial SD a phase II study was done. First of all 4 HIV-infected patients (Group A) with mild/severe SD were treated twice-daily with pimecrolimus cream 1% for 7 days and after this 21 HIV-infected patients (Group B) with mild/severe SD were treated twice-daily with pimecrolimus cream 1% for 14 days. Thereafter, treatment was discontinued and patients followed up for 5 weeks. Skin involvement (erythema, scaling, burning, pruritus, infiltration/papulation, excoriation and lichenification) at baseline, Days 7, 14, 21, 35 and 49 was assessed using a 4-point clinical score and digital photographs. Marked improvement was seen in clinical parameters at Day 7, with >= 90% patients clear of symptoms at Day 14. Erythema and scaling relapsed at Day 35 in approximately 50% of patients, but all symptoms were milder than at baseline. All patients responded to therapy, despite their immunologic status. Pimecrolimus cream represents a new, attractive and effective therapeutic option for facial SD in HIV-patients.

Background: Pimecrolimus cream (Elidel®, SDZ ASM 981), a non-steroid inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms reduces the need for topical corticosteroids. Objective: To investigate the efficacy and safety of pimecrolimus cream 1% in the long-term management of adult AD. Methods: 192 adults with moderate to severe AD were randomised (1:1) for twice daily (b.i.d.) treatment of early signs or symptoms of AD with either pimecrolimus cream 1% or vehicle cream (control group) to prevent progression to flares. Treatment was given as needed for 24 weeks. In the event of flares, a moderately potent corticosteroid (prednicarbate 0.25% cream) was permitted as rescue medication in both groups. The percentage of days on which a topical corticosteroid was used to treat disease flares was the main outcome measure. Results: Corticosteroid medication was used on 14.2% (95% confidence interval, CI: 8.3–21.1) of the days of the 24-week treatment period in the pimecrolimus group and on 37.2% (95% CI: 30.4–44.0) of the days in the control group (p < 0.001). In total, 44.8% (43/96) of patients in the pimecrolimus group did not experience a flare compared with 18.8% (18/96) of patients in the control group. The median time to first flare was 144 days in the pimecrolimus group and 26 days in the control group (p < 0.001). Pimecrolimus treatment was also associated with improvement in signs and symptoms of AD, pruritus, patients’ self-assessment and quality of life. Conclusions: Pimecrolimus cream 1% b.i.d. is an effective, well-tolerated, long-term treatment for AD in adults, substantially reducing the number of flares compared to a conventional therapy and consequently reducing or eliminating the need for corticosteroid treatment. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Background: Pimecrolimus cream 1% is a non-steroid, selective inflammatory cytokine inhibitor indicated for atopic dermatitis (AD). Objective: To compare the safety and efficacy of pimecrolimus cream 1%-based treatment versus conventional therapy in adults with moderate AD. Methods: Patients were randomized to receive pimecrolimus cream 1% (n = 62) or vehicle (n = 68) at the first signs/symptoms of AD, for 24 weeks as required. A moderately potent topical corticosteroid (prednicarbate 0.25% cream) was allowed in both groups to treat flares. Results: Corticosteroids were required on fewer days in the pimecrolimus group, compared with the vehicle group (9.7 vs. 37.8%, p < 0.001). Furthermore, 59.7% of pimecrolimus-treated patients experienced no flares during the study period, compared with 22.1% of vehicle-treated patients (p < 0.001). Pimecrolimus cream 1% was well tolerated throughout the study. Conclusion: For adults with moderate AD, pimecrolimus cream 1% is well tolerated, reduces the incidence of flares, reduces/eliminates corticosteroid use, improves long-term disease control and enhances the patients’ quality of life. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Background: Pimecrolimus cream (Elidel®, SDZ ASM 981), a non-steroid inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms reduces the need for topical corticosteroids. Objective: To investigate the efficacy and safety of pimecrolimus cream 1% in the long-term management of adult AD. Methods: 192 adults with moderate to severe AD were randomised (1:1) for twice daily (b.i.d.) treatment of early signs or symptoms of AD with either pimecrolimus cream 1% or vehicle cream (control group) to prevent progression to flares. Treatment was given as needed for 24 weeks. In the event of flares, a moderately potent corticosteroid (prednicarbate 0.25% cream) was permitted as rescue medication in both groups. The percentage of days on which a topical corticosteroid was used to treat disease flares was the main outcome measure. Results: Corticosteroid medication was used on 14.2% (95% confidence interval, CI: 8.3–21.1) of the days of the 24-week treatment period in the pimecrolimus group and on 37.2% (95% CI: 30.4–44.0) of the days in the control group (p < 0.001). In total, 44.8% (43/96) of patients in the pimecrolimus group did not experience a flare compared with 18.8% (18/96) of patients in the control group. The median time to first flare was 144 days in the pimecrolimus group and 26 days in the control group (p < 0.001). Pimecrolimus treatment was also associated with improvement in signs and symptoms of AD, pruritus, patients’ self-assessment and quality of life. Conclusions: Pimecrolimus cream 1% b.i.d. is an effective, well-tolerated, long-term treatment for AD in adults, substantially reducing the number of flares compared to a conventional therapy and consequently reducing or eliminating the need for corticosteroid treatment. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.