The researchers investigated whether ustekinumab or briakinumab produce remission in people with active Crohn's disease; and whether these medications cause any harms (side effects). The researchers searched the medical literature up to September 16, 2014.
The researchers identified four studies that included a total of 955 participants. Two studies compared briakinumab to placebo (a fake medicine) and two studies compared ustekinumab to placebo. All of the studies were high quality.
There was no difference in the proportion of briakinumab and placebo participants who achieved remission. An increase in side effects or severe side effects were not seen with briakinumab compared to placebo. The most common side effects in briakinumab participants were reactions at the site of injection and infections. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication.
Although more ustekinumab participants achieved remission compared to placebo the difference was not great enough to be statistically meaningful. However, ustekinumab may be better than placebo for reducing symptoms of active Crohn's disease. Different doses of ustekinumab were investigated but it is unclear what dose is most effective. An increase in side effects or severe side effects was not seen with ustekinumab compared to placebo. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious adverse events in the ustekinumab studies. Ustekinumab may be promising as a therapy for improving symptoms in people with Crohn's disease symptoms. However, we are uncertain whether ustekinumab produces remission in people with active Crohn's disease. Further studies are required to determine the effectiveness and safety of ustekinumab in patients with moderate to severe CD. The ideal dose of ustekinumab also needs to be determined. Three studies are currently underway further investigating ustekinumab as a therapy in Crohn's disease. These studies should help to determine if ustekinumab provides a benefit in terms of clinical remission in these patients.
Authors' conclusions:
Although we are uncertain about the efficacy of ustekinumab for induction of remission, moderate quality evidence suggests that ustekinumab may be effective for induction of clinical improvement in patients with moderate to severe CD. Due to small numbers of patients in dose subgroups the optimal dosage of ustekinumab is unclear. Briakinumab and ustekinumab appear to be safe. Due to sparse data we were unable to determine the risk of serious adverse events. Further studies are required to determine the efficacy and safety of ustekinumab in patients with moderate to severe CD. The results of three phase III trials that are currently underway will provide important new information.