Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.
A real-world analysis from Italy assessing nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in some worsening patient-reported outcomes (PROs), which were mostly attributed to the nocebo effect.
The assessment is one of the first studies comparing the real-world effectiveness of nonmedical switching from Humira to an adalimumab biosimilar and between adalimumab biosimilars. The researchers said that their results emphasize the importance for better communication between physicians and patients to ensure that patients’ negative perceptions of biosimilars do not result in worsening PROs.
Humira and adalimumab biosimilars are used to treat several conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), Crohn disease, and ulcerative colitis.
The study analyzed data from patients with inflammatory conditions who switched from Humira or ABP501 (Amgevita), an adalimumab biosimilar, to SB5 (Imraldi), another adalimumab biosimilar, who were treated at the Arthritis Center outpatient clinic at Sapienza University of Rome. Patients gave written consent for the researchers to use their data and the data was followed up to 4 months post switch.
Overall, 110 patients originally taking Humira and 40 patients treated with ABP501 were included, 48.6% of whom were women; the median age was 56 years. By disease state, 33 patients from the Humira group and 12 from the ABP501 group had RA, 40 from the Humira group and 25 from the ABP201 group had PsA, and 37 in the Humira group and 3 from the ABP201 group had axSpA.
In the originator-to-SB5 group, at 4 months post switch, the researchers noted a significant reduction of patients in remission or with low disease activity (P = .009), with a risk reduction (RR) of moderate-high disease activity significantly higher after the switch (RR, 2.6; 95% CI, 1.2-5.7; P = .01). No differences in Disease Activity Score 28 (DAS-28-CRP), disease activity index for psoriatic arthritis (DAPSA), Ankylosing Spondylitis Disease Activity Scores, or Bath Ankylosing Spondylitis Disease Activity Index scores were observed. Twelve patients (10.9%) switched back to the originator, mostly due to lack of efficacy in join involvement or recurrent uveitis.
In the biosimilar-to-biosimilar group, at 4 months after switching, no differences in DAS-28-CRP and DAPSA or changes in the percentage of patients in remission or with low disease activity were found. Also, no differences in PROs were observed. Six patients discontinued SB5 before the end of the follow-up period for lack of efficacy (n = 3) or adverse events (n = 3).
Although the biosimilar-to-biosimilar group had less patients than the originator-to-biosimilar group, the differences in PROs suggests that the nocebo effect may have had an impact. The nocebo effect occurs when a patient’s negative perception about a medication results in reduced effectiveness or adverse events (AEs).
However, the researchers noted that a combination of factors, including the nocebo effect, differences in molecular structures, excipients, and injection devices, could have resulted in reduced PROs.
“In our study, based on the different results obtained after the switch in the 2 groups, we cannot rule out that patients treated with ABP501 biosimilar may be less affected by the nocebo effect than patients initially treated with the bio-originator. Indeed, it is known that switching from an originator to a biosimilar can result in nocebo responses, including a subjective increase in disease activity and pain-related AEs,” they wrote.
The main limitations were population size, the disparities between the 2 groups, and the short follow-up period.
“Nevertheless, our results replicate those reported in the literature, providing a reassuring profile of effectiveness when switching from [adalimumab] originator to one of its biosimilars and between 2 different biosimilars. However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients.”
Reference
Scrivo R, Castellani C, Mancuso S, et al. Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study. Clin Exp Rheumatol. 2023;41(3):613-619. doi: 10.55563/clinexprheumatol/bf00j9
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.