Colombel JF, et al. - The researchers performed this study to provide an update on the long-term safety profile of adalimumab in patients with Crohn's disease (CD) and ulcerative colitis (UC). In patients with moderately to severely active CD and UC, adalimumab continued to be well tolerated. The latest long-term monitoring results discovered no new safety concerns or associations of adalimumab with deaths.

Methods

• Using Medical Dictionary for Regulatory Activities (MedDRA-v18.1), treatment-emergent adverse events (AEs; first dose to 70 days after last dose/December 31, 2015) in adults in phase 2/3 and 3/3b trials and open-label extensions were coded.
• The researchers evaluated rates as events/100 (E/100 PYs).

Results

• The database (16 trials; CD, N = 3606; UC, N = 1739) consisted of 4145 and 3397 PYs of exposure, respectively.
• Incidences of any AEs with adalimumab were 60.8%-65.1%, depending on dose, and 71.5% with placebo; for UC, the incidences were 53.5%-54.8% and 56.1%, respectively for CD.
• The researchers found similar rates of any AEs (CD, 605 E/100 PYs; UC, 361 E/100 PYs), serious AEs (CD, 36.1 E/100 PYs; UC, 18.9 E/100 PYs), and malignancies (CD, 1.2 E/100 PYs; UC, 1.0 E/100 PYs) between current and prior analyses.
• For CD and UC, apparent rate of opportunistic infections was lowered to 0.3 and 0.2 E/100 PYs, respectively, by recent MedDRA changes excluding oral candidiasis and tuberculosis.
• For malignancies, standardised incidence ratios were similar to the general population (CD, 1.45 [95% CI, 0.90-2.22]; UC, 1.36 [95% CI, 0.84-2.07]).
• In this study, demyelinating disorders were uncommon (CD, 0.1 E/100 PYs; UC, <0.1 E/100 PYs).