If Biologic Therapy for IBD Cost a Dollar
Biologic therapy, primarily anti-tumor necrosis factor (TNF) monoclonal antibodies, has been nearly transformative in the treatment of inflammatory bowel disease (IBD). The impediment is cost.
Initially tested in patients with the most refractory bowel disease who were not responding to aminosalicylates, corticosteroids, and/or immunosuppressives, both the potential efficacy and toxicities of biologic therapies targeting TNF-alpha have been clearly elucidated. Infliximab achieved regulatory approval and marketing in the United States in 1998 after clinical trials demonstrated inductive and maintenance benefits for patients with refractory luminal and/or fistulizing Crohn disease. Subsequently, adalimumab and certolizumab pegol received approval on the basis of similar trial designs that enrolled patients refractory to conventional therapies and those who had lost response to infliximab. Infliximab has also achieved regulatory approval for moderate-to-severe ulcerative colitis refractory to aminosalicylates, corticosteroids, and/or immunosuppressives on the basis of 2 large international trials.
The risks of anti-TNF therapy have also been clarified and include common infections (eg, upper respiratory tract infections and pneumonias); a higher risk for infections with intracellular organisms such as Mycobacterium tuberculosis, histoplasmosis, coccidiomycosis, and listeriosis (primarily in endemic environments); and rare manifestations such as worsening demyelination in patients with multiple sclerosis, worsening of heart failure in patients with class III-IV heart failure, and lymphomas. Aside from the risk for infections with intracellular pathogens, demyelination, and worsening heart failure, most toxicities from anti-TNF therapy are amplified by concomitant medications. Infections are increased with both corticosteroids and immunosuppressives, and lymphoma risk is elevated in patients receiving concomitant immunosuppressives.
Impediment to Effective Therapy for Inflammatory Bowel Disease
Biologic therapy, primarily anti-tumor necrosis factor (TNF) monoclonal antibodies, has been nearly transformative in the treatment of inflammatory bowel disease (IBD). The impediment is cost.
Initially tested in patients with the most refractory bowel disease who were not responding to aminosalicylates, corticosteroids, and/or immunosuppressives, both the potential efficacy and toxicities of biologic therapies targeting TNF-alpha have been clearly elucidated. Infliximab achieved regulatory approval and marketing in the United States in 1998 after clinical trials demonstrated inductive and maintenance benefits for patients with refractory luminal and/or fistulizing Crohn disease. Subsequently, adalimumab and certolizumab pegol received approval on the basis of similar trial designs that enrolled patients refractory to conventional therapies and those who had lost response to infliximab. Infliximab has also achieved regulatory approval for moderate-to-severe ulcerative colitis refractory to aminosalicylates, corticosteroids, and/or immunosuppressives on the basis of 2 large international trials.
The risks of anti-TNF therapy have also been clarified and include common infections (eg, upper respiratory tract infections and pneumonias); a higher risk for infections with intracellular organisms such as Mycobacterium tuberculosis, histoplasmosis, coccidiomycosis, and listeriosis (primarily in endemic environments); and rare manifestations such as worsening demyelination in patients with multiple sclerosis, worsening of heart failure in patients with class III-IV heart failure, and lymphomas. Aside from the risk for infections with intracellular pathogens, demyelination, and worsening heart failure, most toxicities from anti-TNF therapy are amplified by concomitant medications. Infections are increased with both corticosteroids and immunosuppressives, and lymphoma risk is elevated in patients receiving concomitant immunosuppressives.
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