By Marilynn Larkin
NEW YORK (Reuters Health) - 17/6/2019
Introduction of infliximab, the first biologic therapy approved for inflammatory bowel disease (IBD) in Canada, did not lead to lower rates of hospitalizations or intestinal surgeries for the disorder in Ontario, researchers say.
"Misguided use of infliximab in CD (Crohn's disease) patients and underuse of infliximab in UC (ulcerative colitis) patients may largely explain our study findings," note Dr. Sanjay Murthy of the University of Ottawa and colleagues.
"In addition to factors relating to physician prescribing and treatment access, patient reticence to receive biologic therapy due to perceived risks of the treatment, may play a role in our observed outcomes," Dr. Murthy told Reuters Health by email. "Because these agents have undergone rigorous study, potential treatment-related adverse events are broadly publicized and easily accessible to patients. Many times, patients do not place the risk of these adverse events in the context of potential adverse events relating to ineffectively treated disease or to conventional immunosuppressants, such as prednisone or azathioprine."
"Overall," he noted, "biologic therapies, including anti-TNF therapies, are among the safest medications that exist to treat inflammatory bowel diseases and offer clear advantages to other therapies in terms of symptom control and quality of life for many patients."
"Improving physician and patient education regarding appropriate timing and indication for treatment and treatment-related adverse events, as well as changing provincial funding criteria to allow more ready access to this treatment when it is clinically indicated, may help to boost usage of this important therapy," he said.
Dr. Murthy and colleagues analyzed data on adults with CD and UC living in Ontario between 1995-2012, studying trends and mean public-payer costs before and after Health Canada approval of infliximab for CD (2001) and UC (2006). The team estimated that publicly-funded infliximab users would represent about 40% of all infliximab users with IBD.
As reported online June 12 in Gut, relative to what would have been expected with conventional therapies alone, marketplace introduction of infliximab did not produce significant declines at the population level in the rates of CD-related hospitalizations (OR at the last observation quarter, 1.06) or intestinal resections (OR, 1.10), or in the rates of UC-related hospitalizations (OR 1.22) or colectomies (OR, 0.933).
Findings were similar for infliximab users with CD; however, among UC patients, hospitalization rates declined substantially following the introduction of infliximab (OR 0.515).
There was a threefold rise over expected trends in public payer drug costs among patients with CD after infliximab introduction (OR 2.98), suggesting robust market penetration in this group, according to the authors; however, no significant change was seen among UC patients (OR 1.06).
Specifically, for CD patients taking infliximab, average annual publicly-funded drug costs rose from approximately $1,000 before infliximab introduction to more than $14,000 by 2012. For UC infliximab users, the mean drug costs rose from approximately $2,500 before infliximab introduction to more than $10,000 by 2012, according to an Ottawa Hospital communication.
Dr. Thomas Ullman, Chief, Gastroenterology at Montefiore Medical Center in New York City, commented by email, "Like the authors, I suspect that use that is less than ideal use has contributed greatly to these findings."
"To achieve its best results, infliximab should be used together with immunomodulators to prevent antibody formation," he told Reuters Health. "It should be given early in the course of disease to assert its best possible effect; later in disease makes it too much of a catch-up game when tissue damage has already occurred and left its mark with scar and/or fistula formation. It should be discontinued - i.e., changed to a different therapeutic approach - when interim targets such as mucosal healing aren't achieved."
"Clinicians should use treatment strategies that result in restoration of a good quality of life for our patients; spare them the burdens of corticosteroid use with its many adverse side effects; lessen mucosal inflammation; and endeavor to keep patients at work or at school and not in hospitals or doctor's offices," he said.
"While (this study) suggests that infliximab, despite its high cost, has not altered Crohn's hospitalizations and surgical trends as prescribed in the Ontario population, that doesn't mean these agents aren't helping our patients," Dr. Ullman added. "It is also worth noting that other Canadian groups have demonstrated reductions in colectomies for patients with ulcerative colitis, 16% per year in Edmonton." (http://bit.ly/2WMQNMX)