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Ulcerative Colitis and Crohn’s Disease

Kunj Gohil PharmD, RPh
Brielle Carramusa

Ulcerative colitis (UC) and Crohn’s disease (CD) are severe ailments affecting the digestive system.1

UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it.2 Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.3

CD can affect any part of the GI tract, but most commonly involves both the large and small intestines.2 Although CD is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.4

Traditional therapies are highly effective in these hard-to-treat diseases. Tumor necrosis factor (TNF) inhibitors are firmly established as treatments but sometimes present problems, such as immunogenicity or an eventual loss of response.4

Vedolizumab (Entyvio, Takeda) is the newest medication for UC and CD, having received FDA approval on May 20, 2014. This novel biologic treatment is not an anti-TNF agent; it is the first gutspecific medication developed solely for UC and CD.5 Future therapies are being developed with the goal of providing patients with highly efficacious options for these complex diseases.3,4

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales / Pricing
Ulcerative Colitis
Xeljanz (tofacitinib)
Pfizer
Phase 3 Oral (5 mg), twice daily
Additional studies are ongoing to support a dose of 10 mg
OCTAVE 2017 $101M in 2022; wholesale price is $2,349 for a 30-day supply, which is about 20%–25% lower than current pricing for Humira
Kappaproct (DIMS 0150)
InDeX Pharmaceuticals
Phase 3 Rectal (30 mg) via colonoscopy with microinjections
Up to 3 doses may be given
COLLECT 2014 (EU) $47M in 2022 (5EU); expected to be priced similar to Alicaforsen (Atlantic Healthcare), which is $9,500 per unit
Crohn’s Disease
Stelara (ustekinumab)
Janssen
Phase 3 One IV injection (approximately 6 mg/kg) at week 0 followed by one SC injection (90 mg) every 8 or 12 weeks thereafter UNITI
CERTIFI
2015 $399.5M in 2022; expected to be priced for CD according to its price per 90-mg dose for its primary indication, psoriasis, which costs $14,747 per dose
Vercimon
ChemoCentryx
Phase 3 Oral (500 mg), once or twice daily SHIELD 2019 $93.6M in 2022; expected to be priced 35% lower than Humira, which costs $1,350 per 40-mg injection

EU = European Union; 5EU = France, Germany, Italy, Spain, and United Kingdom; IV = intravenous; M = million; SC = subcutaneous

Sources: GlobalData; Redbook; FDA

Current Therapies

Drug
Manufacturer
Approval Date Indications Regimen Information Cost of Course of Therapy
Ulcerative Colitis and Crohn’s Disease
Entyvio (vedolizumab)
Takeda
May 20, 2014 Adult UC; adult CD UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter UC/CD: First-year regimen, $43,371 Subsequent 1-year regimens, $33,733
Humira (adalimumab)
AbbVie
UC: September 28, 2012
CD: February 27, 2007
Adult UC; adult CD; adult RA; pediatric JIA; adult PsA; adult AS; adult Ps UC/CD: 4 SC injections at week 0, 2 injections at week 2, and 1 injection every 2 weeks thereafter UC/CD: First-year regimen, $38,790 Subsequent 1-year regimens, $32,534
Remicade (infliximab)
Janssen Biotech
UC: September 16, 2005
CD: August 24, 1998
Adult and pediatric UC; adult and pediatric CD; adult RA; adult AS; adult PsA; adult Ps UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter UC/CD: First-year regimen, $31,856 Subsequent 1-year regimens, $24,777
Ulcerative Colitis Only
Simponi (golimumab)
Janssen Biotech
May 15, 2013 Adult UC; adult RA; adult PsA; adult AS UC: 2 SC injections at week 0, followed by 1 injection at week 2, then 1 injection every 4 weeks thereafter UC: First-year regimen, $49,874 Subsequent 1-year regimens, $40,523
Crohn’s Disease Only
Cimzia (certolizumab pegol)
UCB
April 22, 2008 Adult CD; adult RA; adult PsA; adult AS CD: 2 SC injections at weeks 0, 2, and 4, then every 4 weeks thereafter CD: First-year regimen, $83,075 Subsequent 1-year regimens, $71,998
Tysabri (natalizumab)
Biogen Idec
January 14, 2008 Adult CD; adult MS CD: IV infusion every 4 weeks CD: 1-year regimen, $60,827

AS = ankylosing spondylitis; CD = Crohn’s disease; IV = intravenous; JIA = juvenile idiopathic arthritis; MS = multiple sclerosis; PsA = psoriatic arthritis; Ps = plaque psoriasis; RA = rheumatoid arthritis; SC = subcutaneous; UC = ulcerative colitis

Sources: GlobalData; Redbook; FDA; prescribing information for Entyvio, Humira, Remicade, Simponi, Cimzia, and Tysabri

References

  1. WebMD. A visual guide to inflammatory bowel disease (IBD) Available at: https://www.webmd.com/ibd-crohns-disease/ss/slideshow-inflammatory-bowel-overview. Accessed June 27, 2014
  2. DiPiro J, Talbert RL, Yee G, et al. Inflammatory bowel disease. Pharmacotherapy: A Pathophysiologic Approach 9th edNew York, New York: McGraw-Hill. 2014;497–516.
  3. Global Data. Ulcerative Colitis—Global Drug Forecast and Market Analysis to 2022
  4. Global Data. Crohn’s Disease—Global Drug Forecast and Market Analysis to 2022
  5. FDA. FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease May 202014;Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm398065.htm. Accessed June 27, 2014