Patients with Crohn’s Disease Satisfied with Switch to Adalimumab Biosimilar SB5

A real-world mimicking study of patients with Crohn’s disease transitioning between adalimumab to the biosimilar SB5 demonstrated comparable sustained baseline clinical status across treatment groups. Patients reported both favorable disease control and treatment satisfaction, according to research published in International Journal of Clinical Pharmacy.¹

Although biological medicines have been proven to improve patient outcomes, reduce complications, and reduce the need for hospitalizations and surgery, they are often cost prohibitive. The introduction of biosimilars offers an opportunity to reduce this financial burden while providing equivalent clinical efficacy, functional and preclinical similarity, and quality.²

“Treatment satisfaction has been positively associated with adherence, which is therefore expected to impact outcomes, as well as minimizing the nocebo effect,” wrote a team of investigators including Clare Harris, PhD, MSc, Faculty of Medicine at the University of Southampton, UK. “From the patient perspective, successful transition has more subtle and subjective feature and therefore is critical to the successful implementation of biosimilar medicines.”¹

The iBaSS study is a phase 4, single-center, prospective, randomized, single-blind, cross-over study of adult patients with Crohn’s disease treated at University Hospital Southampton NHS Foundation Trust (UHS). Patients who were stable on adalimumab or the biosimilar prior to enrollment were treated with either reference adalimumab or SB5 for 24 weeks. Data collected included patient-reported outcomes, laboratory measures such as C-reactive protein, fecal calprotectin, and therapeutic drug monitoring. Patient-reported outcomes were measured using the inflammatory bowel disease (IBD)-Control questionnaire and Treatment Satisfaction Questionnaire for Medication (TSQM).¹

The primary endpoint was the proportion of subjects able to sustain baseline clinical status throughout each treatment period. Secondary endpoints included patients’ perspective of both disease control and treatment satisfaction, and changes in disease activity, immunogenicity, biochemical markers, medical treatment, and safety.¹

In total, 112 patients were included in the study, of which 94 (83.9%) completed the 48-week trial. Investigators ensured the cohort was comprised of the heterogenous patient populations seen in routine clinical practice, and the demographics and clinical characteristics were comparable across treatment arms.¹

A similar proportion of patients sustained baseline clinical status (81.8% [n = 72] in the adalimumab group and 79.5% [n = 70] in the SB5 group). The scores from the modified Harvey-Bradshaw Index (mHBI) and biochemical measures were also comparable throughout the trial.¹

The IBD-Control questionnaire showed similar disease control between SB5 and the reference product (15.5 vs 15, respectively), as well as comparable treatment satisfaction. The IBD-Control-VASS questionnaire were also similar between the SB5 and reference groups (83.5 vs 86.5, respectively). Although a higher median injection pain visual analog scale (VAS) score was observed in the SB5 cohort (53/100 vs 6/100, respectively), therapeutic drug monitoring was consistent throughout the treatment periods. Additionally, the number of switches during the study did not impact immunogenicity or serum drug concentration.¹

Most (77.1%) patients reported ≥ 1 adverse event, although the frequency of treatment emergent adverse events was similar between the treatment groups. The most common adverse events were abdominal pain, fatigue, arthralgia, and lung infections.¹

Investigators noted the completeness of data and the crossover design as strengths of the study. However, observer bias may have impacted findings as patients were aware of which drug they were receiving. To mitigate this, investigators employed techniques designed to minimize the nocebo effect, such as monitoring and educating patients on biosimilars.¹

“These findings endorse patient and healthcare professional confidence in the use of biosimilar medicines,” investigators concluded.¹

References

1. ^{Young D, Harris C, Rahmany S, et al. A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS). Int J Clin Pharm. Published online May 11, 2024. doi:10.1007/s11096-024-01739-5}
2. ^{Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478.}