French Study Finds High Patient Satisfaction With Adalimumab Biosimilar Treatment for IBD

An observational study assessing patient satisfaction with adalimumab for inflammatory bowel disease (IBD) reported overall “a high level of satisfaction with adalimumab treatment.” The survey responses showed higher levels of overall patient satisfaction for Hulio, Humira, and Amgevita, and higher levels of satisfaction with the injection device for Yuflyma, Hulio, and Humira, compared to other adalimumab products.

Adalimumab, a monoclonal antibody targeting tumor necrosis factor-α, is used to treat moderate to severe Crohn disease (CD) and ulcerative colitis (UC), chronic inflammatory diseases of the digestive tract collectively called IBD. After patent expiration of the reference product (Humira), several biosimilars became available in Europe. However there are differences in dosage, formulation, and delivery devices across biosimilars. The investigators pointed out that these factors and their impact on adverse events and quality of life can influence a patient’s satisfaction with treatment, which in turn influences treatment compliance, persistence, and adherence. For example, the presence of citrate and larger injection volume in adalimumab products have previously been shown to be associated with pain at the injection site.

The nationwide study in France in centers affiliated with the Groupe d’Etude Therapeutique des Affections Inflammatoires du tube Digestif (GETAID) investigated the satisfaction of patients with IBD with adalimumab biosimilars and the reference product. The study surveyed 941 patients with IBD being treated with adalimumab, 797 (85%) with CD and 141 (15%) with UC, across 45 centers affiliated with the GETAID over 2 2-week periods in 2022. Patients had a median time since diagnosis of 11 years, and most patients were in clinical remission at inclusion. Participants completed a satisfaction questionnaire consisting of 4 items each rated by a 10-point scale: overall satisfaction with adalimumab; satisfaction with the subcutaneous injection form; satisfaction with the injection kit; and satisfaction with support services. In addition, the survey asked about patient characteristics, treatment characteristics, injection site reactions, and previous treatment with different adalimumab products.

Humira (46%), Amgevita (19%), and Hulio (11%) were the most commonly used adalimumab products, followed by Idacio (7%), Hyrimoz (6%), Yuflyma (6%), Imraldi (4%), Amsparity (1%), and Hukyndra (0.1%). The mean overall satisfaction score for adalimumab treatment was 8.5/10 (SD, 1.8), 8.6 (SD,, 1.5) for Humira, 8.6 (SD, 1.8) for Hulio, 8.5 (SD, 1.4) for Amgevita, 8.2 (SD, 1.8) for Hyrimoz, 8.2 (SD, 1.5) for Idacio, 8.2 (SD, 1.7) for Imraldi, 7.8 (SD, 2.1) for Yuflyma, and 6.5 (SD, 2.3) for Amsparity. Overall satisfaction was significantly higher in patients treated with Humira compared to Amsparity or Yuflyma, in patients treated with Hulio compared to Amsparity, and in patients treated with Amgevita compared to Amsparity.

Most patients (83%) used pen devices for subcutaneous injection and performed injections themselves. The mean satisfaction score for an injection pen device was 8.7 (SD, 1.6) and 8.7 (SD, 1.5) for a syringe. Mean satisfaction with the subcutaneous injection form was 9.0 (SD, 1.4) in patients receiving Yuflyma, 8.9 (SD, 1.3) for Humira, 8.9 (SD, 1.7) for Hulio, 8.7 (SD, 1.6) for Amgevita, 8.5 (SD, 1.6) for Hyrimoz, 8.1 (SD, 2.2) for Idacio, 7.8 (SD, 2.2) for Imraldi and 7.2 (SD, 2.5) for Amsparity. Patients receiving Yuflyma, Humira and Hulio rated their satisfaction with the subcutaneous injection form significantly higher than those receiving other adalimumab products.

Satisfaction with the injection kit was rated 8.8 (SD, 1.3) by patients treated with Amsparity, 8.1 (SD, 2.4) for Imraldi, 8.1 (SD, 1.9) for Yuflyma, 7.7 (SD, 2.0) for Amgevita, 7.7 (SD, 2.4) for Idacio, 7.6 (SD, 2.3) for Humira, 7.6 (SD, 2.6) for Hyrimoz, and 7.3 (SD, 2.5) for Hulio. About one-third of patients (32%) reported they did not receive an injection kit at the start of treatment.

Most patients (70%) reported they did not use support services, such as assistance calls, websites, or videos, and 17% reported that no support services had been offered.Mean patient satisfaction with support services was 6.0 (SD, 3.1) in patients receiving Amgevita, 5.4 (SD, 2.7) for Yuflyma, 5.2 (SD, 2.7) for Imraldi, 5.1 (SD, 3.4) for Idacio, 5.0 (SD, 3.3) for Hulio, 4.7 (SD, 3.5) for Humira, 4.5 (SD, 3.7) for Hyrimoz, and 3.8 (SD, 4.7) for Amsparity.

Of the 941 total patients, 299 (32%) reported they had experienced injection site reactions, including 50% of those treated with Amsparity or Imradi, 48% receiving Idacio, 40% receiving Yuflyma, 34% receiving Humira, 28% receiving Hyrimoz, 23% receiving Amgevita, and 17% receiving Hulio. A total of 223 (24%) participants reported previous treatment with a different adalimumab product, of which 32 (14%) discontinued treatment with the previous product due to side effects, and the rest switched from the reference product to a biosimilar. Fourteen of the 32 patients who discontinued the previous adalimumab product due to side effects reported persistent injection site reactions after switching.

The authors concluded that patients with IBD in their study had a high level of satisfaction with adalimumab treatment, “with some differences in terms of overall satisfaction and satisfaction with the injection device.” They said their findings suggest Hulio, Humira, and Amgevita benefit overall patient satisfaction, and Yuflyma, Hulio, and Humira benefit patient satisfaction with the injection device. Currently, they said, the choice between adalimumab products is usually based on non-medical considerations, such as costs or additional services for patients. Since patient satisfaction is associated with better treatment adherence, the authors wrote, “we need to look beyond efficacy and safety by investigating patient satisfaction to be able to make the right choice.”

Reference

Caron B, Seksik P, Buisson A, et al. Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID. Therap Adv Gastroenterol. 2024;17:17562848241265776. doi:10.1177/17562848241265776