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Missing biologics just four days risks flare in IBD
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Patients with inflammatory bowel disease receiving subcutaneous anti-tumor necrosis factor therapy are at a significantly increased risk for disease flare if they miss their medication just 4 days per month, according to new research published in the American Journal of Gastroenterology.
Notably, investigators found that more than 20% of patients who received these drugs fell below this adherence threshold, highlighting the need for interventions to improve adherence.
“Our study highlights the fact that even small gaps in medication refills of biologics are associated with higher risk of hospitalization or steroid use,” Shail M. Govani, MD, MSc, of the University of Michigan and the VA Ann Arbor Healthcare System, told Healio Gastroenterology and Liver Disease. “Patients who delayed their refills just 4 days per 4 weeks on average were more likely to be hospitalized or need a new steroid prescription.”
While acceptable medication adherence has traditionally been considered possession for more than 80% of the intended time of use, a higher adherence threshold may be necessary for anti-TNFs due to the risk of developing auto-antibodies from intermittent use, and the risk of disease flare associated with lower adherence, Govani and colleagues wrote.
To identify an optimal level of adherence to subcutaneous anti-TNFs for preventing IBD flare, Govani and colleagues analyzed claims data to study the medication refill patterns of 5,325 patients prescribed Humira (adalimumab, AbbVie) and 723 prescribed Cimzia (certolizumab pegol, UCB) between 2009 and 2013 (mean age, 41 years; 54% women).
They calculated adherence using the medication possession ratio (MPR; sum of days of medication supplied/sum of days in total refill intervals) from the time patients began therapy to the time of IBD flare, which they defined as hospitalization or a new steroid prescription within 90 days after patients began treatment.
Govani and colleagues identified the optimal MPR at 0.86 for adalimumab and 0.87 for certolizumab pegol, and found 24% of patients fell below this level of adherence.
After adjusting for age, sex and concomitant medications at the beginning of treatment, they found that patients who adhered to treatment above these thresholds were 25% less likely to experience a flare on adalimumab (HR = 0.75; 95% CI, 0.67-0.83) and 41% less likely to experience a flare on certolizumab pegol (HR = 0.59; 95% CI, 0.46-0.76; P < .01 for both). In other words, “patients who possessed their medications less than 86-87% of the time of intended use were more likely to be hospitalized or be treated with corticosteroids,” Govani and colleagues wrote.
“We show that adherence levels should be maximized for these medications, ideally above an MPR of 0.87, with a plateau point of 0.95-0.97, to prevent poor outcomes,” they concluded. “The adherence threshold of 0.87 allows for less than 4 days of missed medication per 28-day period.”
“I use this information in clinic to emphasize to patients the importance of keeping up with refills,” Govani told Healio Gastroenterology and Liver Disease. “I often recommend that they use reminders on their phone to ensure they have as few delays as possible. Yearly insurance re-approvals are unfortunately a barrier to ensuring that our patients receive their medications on time. Hopefully this type of information will help insurance companies reconsider this approach since hospitalizations are so expensive.” – by Adam Leitenberger
Disclosures: The authors report no relevant financial disclosures.
Editor's note: This article was updated on Dec. 14 with additional comments from a study author.
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