OBJECTIVE: Calcineurin inhibitors are highly effective in patients with 
corticosteroid-refractory ulcerative colitis (UC). When therapy with calcineurin 
inhibitors fails, adalimumab can be considered to avoid colectomy. The efficacy 
and safety of this sequential alternative salvage therapy remain unknown. 
Therefore, the present study was performed to investigate the short- and 
long-term efficacy and safety of adalimumab after failure of calcineurin 
inhibitors in corticosteroid-refractory UC.
MATERIALS AND METHODS: Patients with a corticosteroid-refractory flare of UC who 
did not respond to calcineurin inhibitors and received continuing salvage 
therapy with adalimumab were included in this retrospective, observational, 
single-centre study. The cumulative rates of colectomy were calculated using the 
Kaplan-Meier method. Clinical remission and response were evaluated based on the 
Rachmilewitz index. The cumulative rates of colectomy were calculated. 
Predictive factors for clinical remission and colectomy were identified. In the 
safety evaluation, any adverse event occurring after the administration of 
adalimumab was considered.
RESULTS: Forty-one patients were enrolled; 78% had extensive colitis and 87% had 
moderate to severe colitis. Seventeen patients (41%) underwent colectomy during 
the follow-up period. At week 8, 26, and 52 after adalimumab injection, 27%, 
39%, and 32% of patients achieved clinical remission, respectively. The adverse 
event rate was 17%, including one case of tuberculosis.
CONCLUSIONS: The efficacy of adalimumab for calcineurin inhibitor-refractory UC 
was examined for the first time. Treatment with adalimumab avoided the need for 
colectomy in two-thirds of patients with corticosteroid-refractory UC in whom 
calcineurin inhibitors had failed. However, attention is needed to avoid adverse 
events, especially infection.