Adalimumab for maintenance therapy for one year in Crohn's disease: results of a Latin American single-center observational study.
BACKGROUND
Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn's disease patients are scarce.


OBJECTIVE
The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients.


METHODS
Retrospective, single-center, observational study of a Brazilian case series of Crohn's disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05).


RESULTS
Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033).


CONCLUSIONS
Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.
Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Paulo Gustavo
PG
Kotze
Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Vinícius Rezende
VR
Abou-Rejaile
Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Luciana Aparecida
LA
Uiema
Disciplina de Bioestatística, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Marcia
M
Olandoski
Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Maria Cristina
MC
Sartor
Unidade de Cirurgia Colorretal, Universidade Católica do Paraná, Curitiba, PR, Brasil.
Eron Fábio
EF
Miranda
Unidade de Gastroenterologia, Universidade Católica do Paraná - PUCPR, Curitiba, PR, Brasil.
Lorete Maria da Silva
LM
Kotze
Depatamento de Ciurgia Digestiva, Universidade de São Paulo, UNESP, Botucatu, SP, Brasil.
Rogério
R
Saad-Hossne
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D003424:Crohn Disease / Q000188:drug therapy; D060828:Induction Chemotherapy / Q000379:methods; D008137:Longitudinal Studies; D060046:Maintenance Chemotherapy; D012189:Retrospective Studies; D016896:Treatment Outcome
D000068879:Adalimumab; D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized