Introduction:
Ulcerative colitis (UC) is a chronic inflammatory disease of
the large intestine and the rectum. The safety profile of oral aminosalicylates
(perceived as being the safest among UC treatment options) has paved the way
for their use as the primary treatment for patients with mild to moderate UC.
Corticosteroids and immunosuppressants are the mainstay of acute and
maintenance treatment, respectively, for patients with moderate to severe UC.
Long-term use of corticosteroids, however, is associated with severe side
effects, and immunosuppressants carry with them a high rate of toxicity and
risk of opportunistic infections. The unsatisfactory safety profile of
corticosteroids and immunosuppressants has created an opening for biologic
therapies, which have been successfully introduced for treatment of other
inflammatory diseases and are increasingly gaining traction in the UC market.
Using patient-level claims data, as well as insight from 101
surveyed gastroenterologists, we determine the share of each currently marketed
drug by line of therapy, analyze why key drugs are chosen over others, and explain
how gastroenterologists predict this dynamic will change over the next two
years. We delve into how Warner Chilcott’s Asacol (enteric-coated mesalamine) stacks
up against newer aminosalicylate drugs such as Shire’s Lialda (MMX delayed
release mesalamine) and Salix Pharmaceuticals’ Apriso (extended release
mesalamine). We look into how Centocor Ortho Biotech’s Remicade (infliximab), approved for UC since 2005, has started to pave the
road for use of biologics in UC treatment, and we examine how Abbott’s soon-to-be-approved
Humira (adalumimab) may help to change the overall drug landscape for UC. Our
analysis provides critical information for any brand team trying to navigate
the rapidly changing UC market.
Questions Answered in This Report:
*
Lines of therapy: Traditionally, treatment of UC has
followed a “step-up” treatment algorithm in which safer drugs are used earlier,
while more potent but more toxic drugs are reserved for later lines of therapy.
How much first-line patient share goes to Asacol versus newer drugs like
Lialda and Apriso? Which drug classes gain substantial patient share as
patients move from first to third lines of therapy? What share of each line do
Remicade and Humira take?
*
Pathways to key therapies: As specific inhibitors of the
inflammatory cytokine TNF-alpha, Remicade and Humira decrease inflammation via
a more targeted mechanism than any other drug class on the UC market.
How do
the patient pathways to Remicade and Humira
compare? Which biologic has a key opportunity to expand its patient share? Which
drug class most frequently precedes the use of all agents used to treat UC?
Which drugs precede the use of Asacol, Lialda, and Apriso?
*
Physician behavior: Gastroenterologists consider the severity
of disease and multiple drug-specific attributes when choosing a treatment for
UC.
What are the factors motivating gastroenterologists to switch patients
to biologic therapy? Which attributes are the most important for
gastroenterologists when selecting a first-line aminosalicylate or a
first-choice biologic?
*
Forecast: New aminosalicylate drugs have entered the UC
market, and one new biologic agent is set to launch in the next two years.
Will
these drugs substantially change the general treatment algorithm used for UC? Which
class of drugs is currently popular in the UC market but will lose patient
share as anticipated by our surveyed gastroenterologists? Scope:
Primary research: Quantitative results from our
survey of 101 gastroenterologists:
- Physician opinion on how drug use differs by disease severity.
- Most influential drug attributes when physicians choose between
agents.
- Anticipated changes in the line of therapy in which physicians
use key agents.
Primary patient-level data: Quantitative findings
from our analysis of data covering 61 million lives from 98 geographically
diverse U.S. health plans:
- Quantified lines of therapy analysis showing exact share of each
agent in each line of therapy, including rate of progression between lines and
length of time patients are on each line.
- Progression flowcharts through one year of treatment for newly
diagnosed patients receiving each of the following first line agents: Remicade,
Asacol, Lialda, Pentasa, Entocort EC, Canasa, oral corticosteroids, IV
corticosteroids, rectal corticosteroids, azathioprine, rectal mesalamine, sulfasalazine,
balsalazide.
- Flowcharts tracking the preceding therapy patterns for patients
taking each of the following key therapies: Remicade, Humira, Asacol,
Pentasa, Lialda, Apriso, Canasa, Entocort EC, Rowasa, azathioprine,
6-mercaptopurine, rectal mesalamine, sulfasalazine, balsalazide.