Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD

A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had “a high level of satisfaction.” Physicians reported that most of their patients on ABP 501 were in clinical remission, 74% of ABP 501 initiators and 89% of switchers.

ABP 501 (Amgevita), was the first biosimilar adalimumab product approved by the European Medicines Agency and FDA, and was first marketed in Europe in 2018. Biosimilars referencing the originator adalimumab (Humira) entered the US market in 2023, with Amgevita being the first in January.

Conventional treatments are ineffective in up to 40% of patients with IBD, the authors said, but anti-tumor necrosis factor (TNF)-α biologics, such as adalimumab, have “significantly improved” health-related quality of life (HRQoL) in patients with IBD, including Crohn disease (CD) and ulcerative colitis (UC).

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Since IBD prevalence is increasing over time, and is estimated to continue to increase at about 5% per year, the authors wrote, anti-TNF treatment of IBD “will pose a substantial economic burden on healthcare systems,” making biosimilars an important tool for reducing costs.

However, ABP 501 was approved for use in IBD by extrapolation from comparative clinical trials on rheumatoid arthritis and psoriasis, and the authors noted that surveys of US health care providers suggested concerns about the effectiveness of biosimilars. Given the lack of comparative clinical trial data, they aimed to provide real-world evidence from Europe, where ABP 501 has been in use since 2018, which could increase physician and patient confidence in biosimilars.

The investigators used data from the 2020-2021 Adelphi IBD Disease Specific Programme (DSP), a point-in-time survey of gastroenterologists and their patients in France, Germany, Italy, Spain, and the United Kingdom. Participating gastroenterologists completed a survey and provided patient medical records, and patients voluntarily completed questionnaires on HRQoL.

The study included 301 physicians and 375 patients (CD: n = 195; UC: n = 180), 239 patients who initiated ABP 501 as their first adalimumab product, and 136 patients who switched from the reference product to ABP 501. Disease activity was indicated by the Harvey-Bradshaw Index (HBI) in patients with CD and Mayo score in patients with UC.

Patient satisfaction as well as questionnaires evaluating HRQoL were assessed, including the EuroQol-5 Dimension-5 Level (EQ-5D-5L) index], the short version of the Inflammatory Bowel Disease Questionnaire (SIBDQ), and the Work Productivity and Activity Impairment (WPAI) questionnaire.

At the time of the surveys, ABP 501 initiators had been receiving the biosimilar for a median of 7.5 months (IQR, 4.1-14.4); 62% were receiving ABP 501 as monotherapy, and the rest were also receiving conventional therapies. According to physician assessments, 67% of ABP 501 initiators had mild disease severity compared to 0.8% at initiation of therapy, and 74% were assessed by physicians to be in clinical remission. Physicians reported satisfaction with ABP 501 therapy for 92% of patients.

Ninety of the 239 patients who had initiated adalimumab therapy with ABP 501 completed the self-assessment questionnaires. Of these patients, 96% reported being satisfied with treatment, and the authors said questionnaire responses indicated “an overall good HRQoL.” Most patients reported no impairments in mobility (96%), no difficulties with self-care (98%), and no problems performing usual activities (90%). About three-fourths of patients (73%) reported no pain or discomfort, and 23% reported slight pain or discomfort. More than half of patients reported no anxiety or depression symptoms (61%), and 31% reported feeling slightly anxious or depressed. Employed patients reported a 14% overall work impairment.

Patients who had switched from the adalimumab originator to ABP 501 had been treated with Humira for a median of 14 months (IQR, 6.2-28.4) before switching, and had been treated with the biosimilar for a median of 7.7 (IQR, 5.1-13.7) months at the time of the surveys. The authors added that the most frequent reason for switching was cost, either to the health care system or the patient. At the time of the surveys, 68% of switchers were receiving ABP 501 as monotherapy. Based on physician assessments, 83% of RP-ABP 501 switchers had mild disease, and 89% were in clinical remission. Physicians reported satisfaction with ABP 501 therapy for 99% of patients who had switched.

Forty-nine of the 136 patients who had switched from the reference product to ABP 501 completed the questionnaires. Similar to patients who initiated therapy with ABP 501, the authors said the responses suggested “an overall good HRQoL.” Most patients reported no problems with mobility (92%), no problems with self-care (96%), and no problems performing usual activities (81%). More than half of patients (62%) reported no pain or discomfort, and the remaining 38% reported slight pain or discomfort. Most patients reported no anxiety or depression symptoms (79%), and 15% reported feeling slightly anxious or depressed. Patients who were working reported an overall 13% work impairment.

Noting that their study was descriptive and no statistical analysis of differences between groups was conducted, the authors concluded that physicians and patients reported “high levels of satisfaction” for both initiation of therapy with ABP 501 and switching from the reference product to ABP 501.

In both groups, about 90% of patients were reported by their physicians to have achieved clinical remission, and patient self-assessments suggested “minimally impaired” health-related quality of life. The authors said their findings provide “real-world evidence to help reassure both patients and physicians that the patient experience associated with the use of ABP 501 appears similar to that with the RP, regardless of whether the patient is initiated on ABP 501 or has switched” from the reference product.

Reference

Jin R, Nduka C, Courmier D, Knight H, Meadows R, Piercy J, Cummings JRF, Radziszewski W. Real-world experience of adalimumab biosimilar (abp 501) use in patients with inflammatory bowel disease in Europe. Adv Ther. 2024;41(1):331-348. doi:10.1007/s12325-023-02712-w