Treatment options for Crohn’s disease (CD) include conventional, largely generic small molecules and more-potent biological agents, including tumor necrosis factor-alpha (TNF-α) inhibitors. Despite the clinical and commercial success of the TNF-α inhibitors, opportunity remains for agents that can safely and effectively induce and maintain remission in a significant number of patients with moderate to severe CD.
With the recent launch of the cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda’s Entyvio), physicians have a welcome alternative for TNF-α inhibitor-refractory patients. An emerging therapy with a different mechanism of action, the interleukin (IL)-12/IL-23 inhibitor ustekinumab (Janssen’s Stelara), remains in clinical development for moderate to severe CD. However, in the absence of data demonstrating superior efficacy, interviewed thought leaders do not expect these drugs to displace the TNF-α inhibitors as the dominant drug class for moderate to severe CD. The estimated high pricing of ustekinumab, which is already marketed for psoriasis and psoriatic arthritis, and concerns about the risk of progressive multifocal leukoencephalopathy (PML) for vedolizumab will likely limit their potential in the CD market.