Does Adalimumab Biosimilar Increase Risk for Disease Activity?

More than 93% of the patients with stable inflammatory rheumatic joint diseases experienced no signs of disease activity flare or adverse effects after switching from reference adalimumab to a biosimilar, according to a large, real-life observational study published in Rheumatology and Therapy.

“Using a comprehensive approach, we are the first to report on successful nonmedical switch from adalimumab reference Humira (ADA) to adalimumab biosimilar Amgevita (ADAbio) that rendered stable disease activity after transition,” wrote a research team from the Netherlands.

The study included 603 adult patients with an established diagnosis of rheumatoid arthritis, psoriatic arthritis, or spondyloarthritis from the Maasstad Hospital in Rotterdam. In November 2018, all patients who had received treatment with ADA for at least 3 months underwent a nonmedical switch to ADAbio.

Over 1 year of follow-up, the switch was considered successful in terms of disease activity and safety for over 93% of patients. However, 40 patients, or 6.6% of the group, gradually switched back to ADA after shared decision-making, the study found.

A comparison of patients who successfully switched to the biosimilar with patients who switched back to the adalimumab revealed no differences between the groups in either disease activity score in 28 joints using C-reactive protein or adverse effects before and after the switch.

Reasons for switching back to ADA included an increase in arthralgias (70%), a decrease in therapeutic efficacy in a broader sense (5%), the change in injection device from a prefilled syringe to an auto-injection pen (5%), and self-reported worsening of psoriasis in PsA (2.5%).

“The absence of objective measurements, indicating increased disease activity, which could have supported the patient-reported symptoms after the switch to ADAbio, suggests that nocebo effects most likely played a decisive role in the shared decision between patient and rheumatologist to switch back to the bio-originator,” researchers wrote.

“A pre-emptive approach to counteract nocebo effects and stimulate placebo response may have a positive impact on health outcomes for patients and preserve the economic benefits of cost savings that can be achieved by prescribing a biosimilar instead of reference drug.”

—Jolynn Tumolo

Reference:

van Adrichem RCS, Voorneveld HJE, Waverijn GJ, Kok MR, Bisoendial RJ. The non-medical switch from reference adalimumab to biosimilar adalimumab is highly successful in a large cohort of patients with stable inflammatory rheumatic joint diseases: a real-life observational study. Rheumatol Ther. 2022;9(4):1109-1118.