Patients Unsatisfied After Mandatory Adalimumab Biosimilar Transition

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After going through a mandatory nationwide transition to an adalimumab biosimilar in Aotearoa New Zealand, people on the drug reported being unsatisfied during the transition period in an online survey.¹

Not many studies examined the biosimilar transition process, except one in the United Kingdom which focused on the biosimilar adalimumab aimed to treat immune-mediated diseases, such as arthritis, skin psoriasis, and Crohn’s disease. Though, for the previous study, the biosimilar transition was not mandatory. They only aimed to transition at least 80% of patients to a biosimilar.²

During March – September 2022, patients in Aotearoa, New Zealand had a mandatory biosimilar transition to reduce healthcare costs. The biosimilar was the first one for adalimumab in Aotearoa, and it came with a citrate-free preservative to decrease injection pain.²

A new study, led by Chiara Gasteiger, PhD, from the University of Auckland, Auckland, New Zealand, sent online surveys to patients switching from the originator adalimumab to the biosimilar. Ultimately, the investigators wanted to see if patients were satisfied or unsatisfied with the transition, including areas such as care supplies, administrative burdens, information and education, and availability of support. In the survey, patients raised their concerns about the biosimilar’s quality, lack of alcoholic wipes, and the nonexistent support program.

The biosimilar transition was mandatory for everyone but patients with Crohn’s disease at risk of disease destabilization and uveitis at risk of visual loss. Also, patients who experienced unpleasant side effects or disease flares after 4 weeks could return to the bio-originator within the first six months of the biosimilar transition.

The study included 117 participants after exclusion. Participants had to be previously on the adalimumab originator and >18 years old. The sample was mostly women (68%), aged 51 – 61 years old (33%), and had a diagnosis of rheumatoid arthritis (48%).

After the transition period, 85% of the participants continued taking the adalimumab biosimilar. But for participants not on biosimilars after the transition period, 88% returned to the adalimumab, and 17% were taking a completely new treatment. For the participants who reported why they stopped taking the biosimilar, 75% said they had a loss of disease control or efficacy.

With the transition, participants rated their overall mean satisfaction as a 6.2. They were unsatisfied with the support and information received from support organizations, as well as the training for the biosimilar device. Moreover, patients were unsatisfied with the provision of sharp bins (P <.001) and alcohol wipes (P <.001).

The bio-originator had come with alcohol wipes. Because of this, patients did not think about the lack of wipes before injecting the biosimilar.

“The change in care supplies was not communicated to participants, leading to participants sourcing these basic resources,” the investigators wrote.

Respondents were also unsatisfied by nonexistence of a patient support program provided by the manufacturer (P <.001).

“Participants lost the patient support program from the originator manufacturer, which provided [text]/email reminders about when to inject and a help number for nurse support,” investigators wrote. “Patient care must be matched ‘like for like’ to the originator to support patients and reduce negative perceptions about the biosimilar package being cheaper and, therefore, inferior in quality.”

Furthermore, participants reported mixed opinions on the biosimilar’s efficacy—some reported increased flares and loss of disease control.Overall, participants were unsatisfied with the quality of the biosimilar device (P = .024), safety (P <.001), and efficacy (P <.001).

Despite the low mean satisfaction, patients were the most satisfied with the supply of the biosimilar, the pharmacists support during the transition period, and how early in advance they were told about the transition (except some paints were unsatisfied about the lack of initial communication about the biosimilar switch).

Also, over half reported the biosimilar injection was less painful due to citrate free buffer. Some participants said the device was easy to use and worked just as well as the bio-originator. Except, some respondents thought the biosimilar was less effective in reducing arthritis flares and join pain.

“While participants appreciated less injection pain and the ease of the biosimilar device, overall satisfaction with the transition was low,” the investigators concluded. “Patients’ experiences can be improved by providing alcohol wipes, sharps bins, and a comparable patient support program.”

^References

1. ^{Gasteiger C, Lobo M, Stanley R, Wong LS, Murdoch R, Dalbeth N. Rheumatology Patients' Experiences of a Mandatory Nationwide Transition to an Adalimumab Biosimilar. ACR Open Rheumatol. Published online November 23, 2023. doi:10.1002/acr2.11634}
2. ^{Kaneko K, Prieto-Alhambra D, Jacklin C, et al. Influence of information provided prior to switching from Humira to biosimilar adalimumab on UK patients' satisfaction: a cross-sectional survey by patient organisations. BMJ Open 2022; 12:e050949.}