According to the results of a recent study published in the Scandinavian Journal of Gastroenterology, short-term response and clinical remission rates were high in both bio-naive and bio-experienced patients with ulcerative colitis who were treated with adalimumab.
Although the effectiveness of adalimumab in ulcerative colitis has been demonstrated previously in randomized controlled trials, real-life studies are lacking. Therefore, Angelison and colleagues sought to assess the effectiveness and predictive factors associated with outcomes in a large, multicenter, real-life, Swedish cohort.
The team conducted a retrospective analysis of data from 5 Swedish inflammatory bowel disease centers. The outcomes of interest were short-term (3-month) and long-term clinical response and remission rates after starting adalimumab treatment. Researchers conducted a subgroup comparison of bio-naive and bio-experienced (previous infliximab) patient responses and assessed a variety of factors for association with short-term responses. They also evaluated potential predictors of both short-term and long-term failure on adalimumab.
Data from 118 patients (male:female, 1:1) were included in the study. The median age was 34.4 (interquartile range [IQR], 27.0-51.4) years. More patients were bio-experienced (78/118; 66.1%) than bio-naive (40/118; 33.9%). Overall, the median disease duration at inclusion was 4.3 (IQR, 2.0-9.0) years. The median follow-up duration was 1.27 (IQR, 0.33-4.1) years.
After 3 months, 77.1% (91/118) of patients had a clinical response and 32.2% (38/118) achieved corticosteroid-free remission. In a univariate analysis, the only factor predictive of short-term failure to reach corticosteroid-free remission was C-reactive protein >3 mg/L at baseline (odds ratio, 0.19; 95% CI, 0.07-0.5; P =.0008).
Predictors of treatment failure were female sex (hazard ratio [HR], 2.50; 95% CI, 1.38-6.27; P =.0051), concomitant primary sclerosing cholangitis (HR, 5.91; 95% CI, 1.78-19.65; P =.0037), and C-reactive protein >3 mg/L (HR, 3.23; 95% CI, 1.55-6.74; P =.0018).
Patients with older age (>42 years) at diagnosis were more likely to respond to adalimumab (OR, 14.17; 95% CI, 2.96 to >999.9; P =.0085) and continue receiving the drug than younger patients (<20 years; HR, 0.17; 95% CI, 0.30-0.92; P =.0394). Prior failure on infliximab did not affect the adalimumab treatment outcomes.
A total of 14.4% (17/118) of patients discontinued adalimumab treatment because of adverse events, which included malignancies (n=2), infection (n=5), skin rash (n=4), myalgia (n=3), pancreatitis (n=1), psoriasis (n=1), and pulmonary lesion (n=1).
Limitations of the study included the retrospective design and potential selection bias. Heterogenous use of unrecorded additional medication could also influence the results. In addition, physicians assessed short-term efficacy without the use of established indices, biomarkers, or endoscopy, and did not carry out routine drug monitoring during the data collection period.
The authors concluded, “[T]he data presented may provide the clinician important information on the outcome of adalimumab treatment in patients with ulcerative colitis.” The also noted, “short-term response and clinical remission rates were found to be high both in bio-naive and infliximab experienced patients. Higher age at diagnosis and a low CRP-level were predictive of a favorable course both short and long-term.”
Angelison L, Almer S, Davidsdottir L, et al. Short and long-term efficacy of adalimumab in ulcerative colitis: a real-life study [published ahead of print January 21, 2020]. Scand J Gastroenterol. doi:10.1080/00365521.2020.1713210