Crohn’s disease (CD) is an inflammatory bowel disease that
requires chronic therapy (sometimes with expensive biological agents) to treat
symptoms of diarrhea and abdominal pain. Moderate to severe CD is typically
treated with oral corticosteroids and/or immunosuppressants to induce and
maintain remission, respectively, after which patients graduate to treatment
with tumor necrosis factor-alpha (TNF-α) inhibitors. The first approved TNF-α
inhibitor for CD, infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade), remains
the market leader for this indication, but the second approved agent in this
class, adalimumab (AbbVie/Eisai’s Humira), is experiencing increasing uptake as
a first-line biologic. Although current therapies used to treat moderate to
severe disease will see increased competition from novel biologics and oral
small-molecule drugs expected to launch in the near term, substantial
opportunity will remain for additional therapies that can improve upon the
efficacy and safety of marketed agents.
Attributes included in conjoint analysis based assessment of target product profiles for moderate to severe CD:
- Effect on induction of clinical remission at four weeks.
- Effect on maintenance of clinical remission at 54 weeks.
- Effect on closure of all draining fistulas at 54 weeks.
- Effect on mucosal healing at 54 weeks.
- Rate of serious infections (e.g., tuberculosis, sepsis, pneumonia, abscess) at one year.
- Delivery burden (dosing formulation and frequency).
Attributes included in assessment of U.S. payers’ receptivity to new therapies for moderate to severe CD:
- Effect on induction of remission.
- Effect on maintenance of remission.
- Effect on maintenance of response.
- Rate of serious infections.
Physicians surveyed: 60 U.S. and 31 European gastroenterologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade)
- Adalimumab (AbbVie/Eisai’s Humira)
- Certolizumab pegol (UCB’s Cimzia)
- Natalizumab (Biogen Idec’s Tysabri)
- Azathioprine (GlaxoSmithKline/Prometheus Laboratories/UCB’s Imuran, Eisai’s Imurek, generics)
- Ustekinumab (Janssen’s Stelara)
- Vedolizumab (Takeda)
- Vercirnon (GlaxoSmithKline/ChemoCentryx’s Traficet-EN)
- Tofacitinib (Pfizer’s Xeljanz)