A recent study looked to evaluate the association between infliximab trough levels, response to treatment, and quality of life in a cohort of Brazilian irritable bowel disease (IBD) patients.
Despite the effectiveness of infliximab, an anti-tumor necrosis factor (anti-TNF) antibody in the treatment of ulcerative colitis (UC) and Crohn disease (CD), a substantial number of patients eventually lose disease response.
Infliximab trough levels greater than 2-3 μg/ml have been associated with higher rates of sustained clinical and biochemical remission. A recent study looked to evaluate the association between infliximab trough levels, response to treatment, and quality of life in a cohort of Brazilian irritable bowel disease (IBD) patients.
A transversal study was conducted among 71 patients with CD (55) and UC (16) receiving infliximab maintenance therapy of 5mg/kg. Infliximab trough levels were measured from blood samples collected before drug infusion. Complete remission was evaluated using the Harvey Bradshaw Index and partial Mayo Score for CD and UC, respectively. Mucosal healing (MH) was considered Simple Endoscopic Score ≤2 in CD, or a Mayo Endoscopic Subscore of ≤1 in UC.
Of the 71 patients included in the study, 43 (60.5%) had unsatisfactory infliximab trough levels, 35 (49.3%) had active disease, 4 (5.6%) were in complete remission but not MH, and 32 (45%) were in complete response and MH.
Satisfactory trough level (≥3 μg/mL) were associated with complete response and mucosal healing (P <.001). In addition, quality of life was increased if the trough concentration was higher than ≥3 μg/mL3.
Researchers demonstrated that better quality of life in patients with UC and CD is associated with adequate serum levels of infliximab. Participants in the study displayed improvement in intestinal problems, social function, and systemic manifestations.
According to the study authors, while therapeutic drug monitoring is not routinely conducted within Brazil, it has been shown to improve treatment outcomes and have important economic benefits in patients with IBD. This is because while individualized therapy based on immunopharmacological evidence has similar complete response rates compared to dose intensification strategies.
However, when a physician looks to “blindly” optimize dosing instead of making the decision based off of the patient’s infliximab trough level, the treatment cost is much higher. Although therapeutic drug monitoring can be a useful tool in patients losing disease response, the researchers note that further prospective studies are needed to confirm the results.
Reference
Parra R, Feitosa M, Ribeiro L, Castro L, Rocha J, Feres O. Infliximab trough levels and quality of life in patients with inflammatory bowel disease in maintenance therapy [published online May 8, 2018]. Gastroenterol Res Pract. doi: 10.1155/2018/1952086.
Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab
January 14th 2025The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals
January 11th 2025Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Equivalence Confirmed: CT-P41 Paves the Way for Affordable Osteoporosis Care
January 8th 2025Celltrion’s denosumab biosimilar demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.