When treating any disease, adherence is key. Specifically, however, in inflammatory bowel disease (IBD), adhering to biologic therapy is critical in the management of these diseases, as previous research has demonstrated that a medication possession ratio (MPR) of less than 0.86 significantly increases the risk of disease flare.
When treating any disease, adherence is key. Specifically, however, in inflammatory bowel disease (IBD), adhering to biologic therapy is critical in the management of these diseases, as previous research has demonstrated that a medication possession ratio (MPR) of less than 0.86 significantly increases the risk of disease flare.
To further explore the risk factors in non-adherence, researchers presenting their findings at the American College of Gastroenterology’s annual meeting conducted a retrospective study1 to evaluate patients treated at a tertiary care IBD center prescribed a biologic therapy (either adalimumab, certolizumab, golimumab, or ustekinumab). To be included in the study patients had to have filled 3 prescription claims with the center’s specialty pharmacy.
MPR was calculated as the days’ supply for all prescription claims divided by the total number of days that had elapsed during the study period. Non-adherence to medication was defined as MPR less than 0.86.
In total, the researchers enrolled 560 patients (393 patients with Crohn disease [CD] and 67 with ulcerative colitis [UC]) in the retrospective analysis. The overall mean MPR was 0.89. Researchers found that 71% of patients with CD and 87% of patients with UC were adherent. However, the study was able to identify several risk factors that increase the risk of non-adherence in a univariate analysis including a diagnosis of CD, insurance type, psychiatric history, smoking, prior biologic use, and narcotic use.
In patients with CD, as the number of risk factors present increased, the probability of non-adherence significantly increased. The study authors identified that adherence was 77% and 73% in patients with 0-1 risk factors, decreasing to 65%, 61%, and 37% in patients with 2, 3, or 4 risk factors, respectively (P <.05).
Another study2 presented at the meeting sought to identify treatment outcomes of patients with IBD with early disease control. In order to evaluate biologic treatment outcomes in early CD and UC, researchers conducted a systematic literature review.
In total, 19 studies in CD (6 clinical and 13 observational), 3 in UC and 1 in both CD and UC (all observational) were included in the review. Studies evaluated the effectiveness of infliximab (CD: 15 papers, UC: 4 papers), adalimumab (CD: 9 papers, UC: 3 papers) and certolizumab pegol (CD: 4 papers) as mono- or combination biologic therapy with conventional therapy.
The study authors reported that risk factors for disease progression were noted at baseline only in select studies. Outcomes were assessed at >54 weeks in 10 (50%) of CD studies and 3 (75%) UC studies.
The researchers recommended that there needs to be a more thorough consideration of patients’ baseline risk of disease progression and assessment of long-term outcomes in order to more effectively evaluate early biologic use in achieving disease control.
For future studies, the authors also noted that the measures of these outcomes should also be consistent to support comparisons among the interventions.
References
1. Haydek J, Shah N, Slaughter J, et al. risk factors for medication non-adherence to biologic therapy in patients with inflammatory bowel disease: a retrospective analysis. Presented at the 83rd Annual Scientific Meeting of the American College of Gastroenterology, October 5-10, 2018; Philadelphia, Pennsylvania. Abstract 570. https://www.nature.com/articles/s41395-018-0296-0.pdf.
2. Jairath V, Wright D, Calleja A, et al. Assessment of biologic treatment outcomes in inflammatory bowel disease patients with ‘early disease’: results of a systematic literature review.Presented at the 83rd Annual Scientific Meeting of the American College of Gastroenterology, October 5-10, 2018; Philadelphia, Pennsylvania. Abstract 584. https://www.nature.com/articles/s41395-018-0296-0.pdf.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.