Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients

FUNDAMENTOS – Tacrolimo pomada é eficaz no tratamento da dermatite atópica. OBJETIVOS – Avaliar a eficácia e segurança do tacrolimo pomada 0,03% (Protopic®) no tratamento de pacientes pediátricos com dermatite atópica. MÉTODOS – Estudo multicêntrico, aberto e não comparativo. Incluídos 174 pacientes (dois a 10 anos) com dermatite atópica. Utilizou-se tacrolimo duas vezes ao dia, por seis semanas. O critério primário de eficácia foi a melhora clínica > a 90% avaliada pelo médico (Escala de Avaliação Global da Resposta Clínica). Outros critérios de eficácia foram a redução no índice de área e gravidade do eczema (EASI), a redução do percentual de superfície corporal afetada (%BSA) e a avaliação do prurido pelo paciente (escala analógica visual). Segurança foi avaliada pela ocorrência de eventos adversos relatados pelos pais e pacientes ou pelos investigadores. RESULTADOS – Trinta e três por cento dos pacientes apresentaram melhora clínica >90%. Quando avaliado o escore EASI, houve redução de 45,5% (primeira semana) e 61,8% (sexta semana) quando comparado com o basal (p 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement >90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequent adverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients

Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients

FUNDAMENTOS – Tacrolimo pomada é eficaz no tratamento da dermatite atópica. OBJETIVOS – Avaliar a eficácia e segurança do tacrolimo pomada 0,03% (Protopic®) no tratamento de pacientes pediátricos com dermatite atópica. MÉTODOS – Estudo multicêntrico, aberto e não comparativo. Incluídos 174 pacientes (dois a 10 anos) com dermatite atópica. Utilizou-se tacrolimo duas vezes ao dia, por seis semanas. O critério primário de eficácia foi a melhora clínica > a 90% avaliada pelo médico (Escala de Avaliação Global da Resposta Clínica). Outros critérios de eficácia foram a redução no índice de área e gravidade do eczema (EASI), a redução do percentual de superfície corporal afetada (%BSA) e a avaliação do prurido pelo paciente (escala analógica visual). Segurança foi avaliada pela ocorrência de eventos adversos relatados pelos pais e pacientes ou pelos investigadores. RESULTADOS – Trinta e três por cento dos pacientes apresentaram melhora clínica >90%. Quando avaliado o escore EASI, houve redução de 45,5% (primeira semana) e 61,8% (sexta semana) quando comparado com o basal (p 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement >90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequent adverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients

Journal of the European Academy of Dermatology and Venereology

Texto completo: acesso restrito. p. 611–618Background  The relapsing nature of melasma emphasizes the need to maintain efficacy achieved after acute treatment. Objective  To compare clinical efficacy and safety of two 6-month Triple Combination (TC; containing fluocinolone acetonide, hydroquinone and tretinoin) maintenance regimens in subjects with moderate to severe melasma, after daily treatment up to 8 weeks. Methods  This randomized, investigator-blinded, controlled study had a maintenance phase of 6 months. Sixteen centres in Brazil and Mexico enrolled 242 subjects 18 years or older attaining no or mild melasma after 8 weeks of daily TC applications. Subjects were randomized to receive TC in a twice weekly or tapering regimen [3/week (1st month), 2/week (2nd month), 1/week (4th month)]. Efficacy and safety measurements included median time to relapse and relapse-free rate, Global Severity Score, Melasma Area and Severity Index score (MASI), subject’s assessment, quality of life questionnaire (MelasQol), and adverse events. Results  The majority (78.8%) had no or mild melasma (GSS ≤ 1) at week 8 and entered maintenance phase. After 6 months, 53% of patients remained relapse-free with improved quality of life, and time to relapse was similar between groups (about 190 days). Melasma severity at study entry, not maintenance baseline, influenced relapse rate. The twice weekly regimen tended to show better effectiveness in postponing relapse in severe melasma. Both regimens were safe. Conclusions  After resolution of melasma with TC, maintenance therapy over 6 months was successful in preventing relapse in over half of the patients who entered maintenance phase. Prescribing medicines should be adapted to patients based on melasma severity

Avaliação da eficácia e segurança do tacrolimo pomada 0,03% no tratamento da dermatite atópica em pacientes pediátricos Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients

FUNDAMENTOS - Tacrolimo pomada é eficaz no tratamento da dermatite atópica. OBJETIVOS - Avaliar a eficácia e segurança do tacrolimo pomada 0,03% (Protopic®) no tratamento de pacientes pediátricos com dermatite atópica. MÉTODOS - Estudo multicêntrico, aberto e não comparativo. Incluídos 174 pacientes (dois a 10 anos)com dermatite atópica. Utilizou-se tacrolimo duas vezes ao dia, por seis semanas. O critério primário de eficácia foi a melhora clínica > a 90% avaliada pelo médico (Escala de Avaliação Global da Resposta Clínica). Outros critérios de eficácia foram a redução no índice de área e gravidade do eczema (EASI), a redução do percentual de superfície corporal afetada (%BSA) e a avaliação do prurido pelo paciente (escala analógica visual). Segurança foi avaliada pela ocorrência de eventos adversos relatados pelos pais e pacientes ou pelos investigadores. RESULTADOS - Trinta e três por cento dos pacientes apresentaram melhora clínica >90%. Quando avaliado o escore EASI, houve redução de 45,5% (primeira semana) e 61,8% (sexta semana) quando comparado com o basal (p<0,001). Em relação a %BSA, houve redução de 30,4% e 55,5%, na primeira e na sexta semana. Houve redução do prurido em relação ao basal (p<0,001).Os eventos adversos mais comuns foram - queimação e prurido localizados. CONCLUSÃO - Tacrolimo pomada 0,03% é terapia segura e efetiva no tratamento da dermatite atópica leve a grave em pacientes pediátricos.<br>BACKGROUND: Tacrolimus ointment has been shown to be effective in treatment of atopic dermatitis. OBJECTIVES: To evaluate the efficacy and safety of 0.03% tacrolimus ointment (Protopic®) in pediatric patients with mild, moderate and severe atopic dermatitis. METHODS: Open, non-comparative, multicentric study carried out in Brazil. 174 patients (ages from two to 10) with mild to severe atopic dermatitis were included. Patients were instructed to apply Protopic® twice a day for six weeks. Primary efficacy criterion was clinical improvement > 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement > 90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequentadverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients

International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients with Psoriasis

Importance: A clear dosing regimen for methotrexate in psoriasis is lacking, and this might lead to a suboptimal treatment. Because methotrexate is affordable and globally available, a uniform dosing regimen could potentially optimize the treatment of patients with psoriasis worldwide. Objective: To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics. Design, Setting, and Participants: Between September 2020 and March 2021, a survey study with a modified eDelphi procedure that was developed and distributed by the Amsterdam University Medical Center and completed by 180 participants worldwide (55 [30.6%] resided in non-Western countries) was conducted in 3 rounds. The proposals on which no consensus was reached were discussed in a conference meeting (June 2021). Participants voted on 21 proposals with a 9-point scale (1-3 disagree, 4-6 neither agree nor disagree, 7-9 agree) and were recruited through the Skin Inflammation and Psoriasis International Network and European Academy of Dermatology and Venereology in June 2020. Apart from being a dermatologist/dermatology resident, there were no specific criteria for participation in the survey. The participants worked mainly at a university hospital (97 [53.9%]) and were experienced in treating patients with psoriasis with methotrexate (163 [91.6%] had more than 10 years of experience). Main Outcomes and Measures: In a survey with eDelphi procedure, we tried to reach consensus on 21 proposals. Consensus was defined as less than 15% voting disagree (1-3). For the consensus meeting, consensus was defined as less than 30% voting disagree. Results: Of 251 participants, 180 (71.7%) completed all 3 survey rounds, and 58 participants (23.1%) joined the conference meeting. Consensus was achieved on 11 proposals in round 1, 3 proposals in round 2, and 2 proposals in round 3. In the consensus meeting, consensus was achieved on 4 proposals. More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients. Conclusions and Relevance: In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis. This consensus may potentially be used to harmonize the treatment with methotrexate in patients with psoriasis.