The adalimumab (ADA) biosimilar HS016 shows strong efficacy and safety among inflammatory bowel disease (IBD) patients in China, according to recent findings, with the real-world data aligning with prior trials on the efficacy of HS016 with Crohn's disease patients.¹

These new findings resulted from a study looking into the efficacy and safety of HS016, an ADA biosimilar. While there have been successful comparative studies in the US and Europe between ADA and biosimilars, the ADA biosimilars in China are noted as having some unique characteristics.^2,3

This new research on Chinese IBD patients’ response to HS016 was led by Fang Wang, from the National Clinical Research Center for Digestive Diseases at the Xijing Hospital of Digestive Diseases in China.

“In this study, we retrospectively analyzed the real-world data of HS016 in IBD treatment from one of the biggest IBD centers in China,” Wang and colleagues wrote. “In addition, we further discussed the factor (TDM) on the efficacy of HS016, providing more evidence and suggestions for clinical decision-making.”

Background and Findings

The investigators considered a total of 103 individuals with IBD for treatment with the biosimilar HS016 at Xijing Hospital in China from October 2020 - April 2022. Their use of the biologic ADA was indicated for those who fell into 3 categories: those who ended up not responding to traditional treatments, those reporting recurring ulcers via endoscopy, and those in need following CD surgery to prevent recurrence as early use of biologics has been shown to enhance recovery rates and diminish complications.

This study focused on the first 2 types of participants, specifically. The research team’s criteria for exclusion involved subjects who were not clinically suitable, those whose ulcers were not able to be distinctly separated from other conditions, those preparing for IBD surgery, those who were pregnant or planning to be, or those that had different conditions hindering participation.

Among the first 103, 12 of the subjects in total were excluded and 91 were kept—75 with Crohn’s disease (CD) and 14 with ulcerative colitis (UC)—who met the criteria the team decided upon. The investigators looked at demographic and clinical information such as age, weight, gender, height, complications, duration of patients’ disease, prior medications, type of disease, and surgical history.

The individuals with IBD were treated with HS016, with the research team beginning with a 160 mg dose at the point of baseline, followed by an 80 mg dose by the second week, and then 40 mg every other week. If it was shown to be insufficient, the dose would be raised to 40 mg per week by the clinician.

In cases where the study subjects did not exhibit a positive response to the treatment, therapeutic drug monitoring (TDM) was implemented by the investigators. Later, among individuals categorized as "nonresponders" following either 3 or 6 months of therapy, the team assessed the serum TNFα concentrations of 20 subjects and looked into their correlation with the severity of their respective conditions.

Among the 61 active CD patients, substantial results were reported by the research team over a 52-week period. At the point of 12 weeks, the team found that 75.4% had a clinical response, while 55.7% reported clinical remission.

These percentages were shown to lower to 73.8% and 65.6% at 26 weeks, and then 50.8% and 45.9% at the 52-week mark for clinical response and remission, respectively. Among those with CD who were in clinical remission, the investigators found that remission was maintained at 100% by 12 weeks, 78.6% at 26 weeks, and 63.6% by the 52-week mark.

In the case of active UC patients, the research team found that 37.5%were able to achieve clinical response at the 12-week mark and 50% at 26 weeks. They noted that the total adverse event rate during the 52-weeks of research was shown to be 5.5%.

Additionally, the investigators found that around 30.4% of subjects reported experiences of poor clinical responses resulting from inadequate serum drug concentration. They also found that 4.3% had elevations of serum anti-drug antibodies.

Overall, the research team confirmed the biosimilar’s efficacy and safety among Chinese patients with IBD.

“As research continues, we are confident that increasing biological agents will appear for IBD therapy,” they wrote. “Additionally, biosimilars will stimulate competition in the market and have incredible potential to expand patient exposure to biologics in the context of treatment recommendations.”

References

1. ^{Wang F, Li X, Shi Y, et al. Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study. Front Pharmacol. 2023;14:1259183. Published 2023 Oct 16. doi:10.3389/fphar.2023.1259183.}
2. ^{Hanauer, S. B., Sandborn, W. J., Rutgeerts, P., Fedorak, R. N., Lukas, M., MacIntosh, D., et al. (2006). Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 130 (2), 323–333. quiz 591. doi:10.1053/j.gastro.2005.11.030.}
3. ^{Derikx, L., Dolby, H. W., Plevris, N., Lucaciu, L., Rees, C. S., Lyons, M., et al. (2021). Effectiveness and safety of adalimumab biosimilar SB5 in inflammatory bowel disease: outcomes in originator to SB5 switch, double biosimilar switch and bio-naïve SB5 observational cohorts. J. Crohns Colitis 15 (12), 2011–2021. doi:10.1093/ecco-jcc/jjab100.}