In Crohn disease (CD), anti–tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.
In Crohn disease (CD), anti—tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.
The retrospective study was conducted among 157 patients with CD who were treated with adalimumab between 2008 and 2016 at a single center in Italy. The investigators analyzed whether early treatment with adalimumab (within 12 months of diagnosis with CD) improved patient outcomes.
The patients had a mean age of 43.99 years, and 68.15% were men. Most of the patients (91.01%) had received systemic corticosteroids before starting adalimumab, but not all responded to steroid treatment. Seventy-five of the patients had also used other therapies, including infliximab, azathioprine, and antibiotics.
At month 12 after initiating adalimumab, overall, 50.32% of patients achieved clinical remission. A clinical response was observed in 35.03% of patients. Among both those in remission and those with a response, 62.42% did not need steroids, and 37.58% showed mucosal healing.
Among the 80 patients who started adalimumab within 1 year of diagnosis, the clinical remission rate (66.25%) was significantly superior to the remission rate (33.77%) among the 77 patients who started adalimumab more than 1 year from diagnosis (P ≤.001).
Mucosal healing was observed in 53.75% of the early treatment group and in 20.78% of the late treatment group (P <.001), and dose escalation was required for 30.00% of the early treatment group and in 66.23% of the late treatment group (P <.01).
Finally, 7.50% of patients in the early treatment group were classified as nonresponders at the end of follow-up, versus 22.08% of patients in the late treatment group.
Early treatment with adalimumab, write the study’s authors, may improve clinical outcomes by preventing fibrosis from developing by blocking the cascade of events leading to the fibrogenic process. “In light of our data, it is tempting to speculate that early control of gut inflammation is critical to prevent fibrostenotic intestinal injury previously described as a major factor leading to poor patient outcomes,” they write, adding that these data support introducing adalimumab during a “window period” before there are structural alterations to the bowel.
Reference
Mastronardi M, Curlo M, Cavalcanti E, et al. Administration timing is the best clinical outcome predictor for adalimumab administration in CD. Front Med (Lausanne). 2019;6:234. doi: 10.3389/fmed.2019.00234.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Trastuzumab-dkst Shows Promising Results in Real-World Setting for HER2+ Breast Cancer
July 9th 2024A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.