RESUMO
BACKGROUND: Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (UC) are scarce. The aim of this study was to assess the long-term efficacy and safety of AZA in patients with steroid-dependent UC, as well as factors associated with sustained response. MATERIAL/METHODS: In this prospective observational study 46 adult subjects with steroid-dependent UC were included for AZA therapy during a 12-month period. AZA dosage was adjusted according to clinical response and occurrence of adverse events. Steroid therapy was tapered according to protocol. The primary endpoint was the rate of steroid-free remission to AZA at the end of 12 months. Secondary endpoints included clinical relapse, cumulative steroid dose and safety of treatment. RESULTS: On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at the end of 12 months was 0.54. The median time until complete steroid withdrawal was 5 months. A significant decrease in the relapse rate and in requirement for steroids were observed during 12 months on AZA compared with the prior year (P=0.000). Demographic, dose of AZA, steroid use, and disease-related data did not correlate with remission. Only disease duration <24 months was associated to steroid-free remission (P=0.03, OR 3.60 95% CI 1.95-9.74). Serious adverse events related to AZA were uncommon. CONCLUSIONS: AZA demonstrated sustained efficacy for maintenance of clinical remission without steroids and steroid sparing through 12 months of therapy in steroid-dependent UC. Patients with early onset UC are those who most probably will achieve sustained steroid-free remission while on AZA.
Assuntos
Corticosteroides/uso terapêutico , Azatioprina/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Adolescente , Adulto , Idade de Início , Azatioprina/efeitos adversos , Demografia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To assess the incidence of mood swings (MS) and possible associated factors in patients with Crohn's disease (CD). METHODS: Prospective longitudinal study of 50 patients (60% females; mean age 40.6 years) with a diagnosis of CD over a 16-month follow-up. Clinical activity was assessed by the CD activity index. Psychological status self-report tools (Beck Depression Inventory and the anxiety subscale of the Hospital Anxiety and Depression Scale) were used for mood disorder diagnosis. The tools were applied at baseline and at four-month intervals thereafter. RESULTS: The inflammatory phenotype was the most common (86%); 36% had a previous history of surgery related to CD; 82% were in clinical remission at baseline. MS occurred in 58% of patients; 28% had progression of depression and/or anxiety symptoms from baseline normal mood, and 30% had baseline depressive and/or anxious mood normalized. In 38% of patients with MS, no change in the disease clinical activity could be found (p = 0.015), whereas 20% had a change in CD activity. Female gender and absence of previous surgery related to CD complications were associated with higher MS incidence (p = 0.04 for both). CONCLUSION: In this study, a high MS incidence (58%) was found in patients with CD. Female gender and absence of previous surgery from CD complications were associated with a higher MS incidence. Periodic psychological assessment could be useful to detect and approach MS in patients with CD.
Assuntos
Doença de Crohn/psicologia , Transtornos do Humor/epidemiologia , Adolescente , Adulto , Idoso , Ansiedade/epidemiologia , Ansiedade/etiologia , Brasil/epidemiologia , Doença de Crohn/epidemiologia , Depressão/epidemiologia , Depressão/etiologia , Feminino , Seguimentos , Humanos , Incidência , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Transtornos do Humor/psicologia , Estudos Prospectivos , Escalas de Graduação Psiquiátrica , Fatores Sexuais , Fatores Socioeconômicos , Adulto JovemRESUMO
BACKGROUND: Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (SD-UC) are scarce. The purpose of this trial was to explore the efficacy of AZA in maintaining steroid-free remission in SD-UC patients and the factors associated with sustained response. METHODS: In this observational cohort study, 42 subjects with SD-UC were recruited for AZA therapy during a 3-year period. AZA was adjusted for a target dose of 2-3 mg/kg/day. Steroid therapy was tapered off following a standardized regimen. The primary endpoint was the annual rate of steroid-free response to AZA. Secondary endpoints included clinical recurrence, yearly steroid dose, and safety of treatment. RESULTS: On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at 12, 24, and 36 months was 0.55, 0.52, and 0.45, respectively. A significant decrease in the flare-ups rate and in requirement for steroids were observed during 3 years on AZA compared with the previous year (P = 0.000 for both). Patients with and without sustained response were comparable according to demographics, extent of disease, dose of AZA, steroids, and 5-aminosalicylate (5-ASA) use. Only disease duration <36 months was associated with off-steroids remission (P = 0.02, odds ratio [OR] 3.12, 95% confidence interval [CI] 1.89-7.64). The AZA benefit-risk profile was favorable. CONCLUSIONS: In this open-label observational trial AZA showed sustained efficacy for maintenance of clinical remission off steroids and steroid sparing through 3 years of therapy in SD-UC. Patients with earlier UC are those who most probably will have sustained steroid-free remission at the end of 12 months while on AZA.
Assuntos
Corticosteroides/farmacologia , Azatioprina/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Imunossupressores/uso terapêutico , Adolescente , Adulto , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJETIVO: Avaliar em portadores de doença de Crohn (DC) a incidência de oscilação do humor (OH) e os possíveis fatores associados à mesma. MÉTODOS: Estudo prospectivo longitudinal com 50 pacientes (60% sexo feminino; média de idade de 40,6 a) com diagnóstico de DC acompanhados por 16 meses. A atividade clínica foi avaliada pelo índice de atividade da DC. Utilizaram-se os instrumentos de autoavaliação do estado psicológico (Inventário de Depressão de Beck e subescala de ansiedade da Escala Hospitalar de Ansiedade e Depressão) para diagnóstico de transtorno de humor. Os instrumentos foram aplicados na inclusão no estudo e, a seguir, em intervalos de quatro meses. RESULTADOS: O fenótipo inflamatório foi o mais comum (86%), 36% tinham história prévia de cirurgia relacionada com DC; 82% estavam em remissão clínica na inclusão. OH ocorreu em 58% dos pacientes; 28% evoluíram com sintomas depressivos e/ou ansiosos a partir do humor normal de base e 30% normalizaram o humor depressivo e/ou ansioso de base. Em 38% dos pacientes com OH não houve mudança na atividade clínica da doença (p = 0,015), enquanto 20% tiveram alteração na atividade da DC. Sexo feminino e ausência de cirurgia prévia relacionada com complicações da DC foram associadas à maior incidência de OH (p = 0,04 para ambos). CONCLUSÃO: Neste estudo, verificou-se elevada incidência (58%) de OH em pacientes com DC. O sexo feminino e ausência de cirurgia prévia por complicações da DC foram associadas à maior incidência de OH. Avaliação psicológica periódica pode ser útil para detecção e abordagem de OH em pacientes com DC.
OBJECTIVE: To assess the incidence of mood swings (MS) and possible associated factors in patients with Crohn's disease (CD). METHODS: Prospective longitudinal study of 50 patients (60% females; mean age 40.6 years) with a diagnosis of CD over a 16-month follow-up. Clinical activity was assessed by the CD activity index. Psychological status self-report tools (Beck Depression Inventory and the anxiety subscale of the Hospital Anxiety and Depression Scale) were used for mood disorder diagnosis. The tools were applied at baseline and at four-month intervals thereafter. RESULTS: The inflammatory phenotype was the most common (86%); 36% had a previous history of surgery related to CD; 82% were in clinical remission at baseline. MS occurred in 58% of patients; 28% had progression of depression and/or anxiety symptoms from baseline normal mood, and 30% had baseline depressive and/or anxious mood normalized. In 38% of patients with MS, no change in the disease clinical activity could be found (p = 0.015), whereas 20% had a change in CD activity. Female gender and absence of previous surgery related to CD complications were associated with higher MS incidence (p = 0.04 for both). CONCLUSION: In this study, a high MS incidence (58%) was found in patients with CD. Female gender and absence of previous surgery from CD complications were associated with a higher MS incidence. Periodic psychological assessment could be useful to detect and approach MS in patients with CD.