The adalimumab biosimilar Cyltezo (adalimumab-adbm; Boehringer Ingelheim) has demonstrated similar patient-reported outcomes compared to the reference product Humira (adalimumab) in the VOLTAIRE-RA trial, offering a cost-effective alternative for patients with moderate to severe rheumatoid arthritis (RA). The study, which randomized patients to either the biosimilar or Humira, found comparable efficacy and safety profiles between the two treatments.
The VOLTAIRE-RA trial assessed patient-reported health status using a 36-item questionnaire (SF-36), evaluating eight domains including physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations, and mental health. These outcomes were grouped into physical component summary (PCS) and mental component summary (MCS) scores. Patients also completed surveys assessing their perception of disease activity and health-related quality of life.
Comparable Improvements in Physical and Mental Health
At 12 and 24 weeks, both treatment groups showed similar improvements in PCS and MCS scores. Specifically, mental component scores improved by 70% in the Humira group and 68% in the biosimilar group, while physical component scores improved by 59% and 56%, respectively. These levels of improvement were considered clinically important. No significant differences in PCS scores were observed between the groups at baseline, week 12, or week 24. Although MCS scores were slightly higher in the Humira group at baseline, improvements at weeks 12 and 24 were similar across both groups.
Consistent Symptom Reduction and Side Effects
The study also revealed that participants receiving the biosimilar experienced similar symptom reduction and side effects as those receiving Humira. This finding suggests that switching from Humira to the biosimilar does not compromise treatment efficacy or patient well-being. According to Vibeke Strand, MD, clinical professor in the division of immunology/rheumatology at Stanford University School of Medicine, the trial reported "similar substantial benefits across a range of patient-reported outcomes" for participants randomized to either treatment.
Implications for Rheumatoid Arthritis Treatment
Adalimumab, a monoclonal antibody targeting tumor necrosis factor-α, has been a cornerstone in RA treatment since its approval in the US in 2002 and in Europe in 2003. Adalimumab-adbm was the first adalimumab biosimilar approved as interchangeable with Humira by the FDA. The VOLTAIRE-RA trial provides further evidence supporting the use of adalimumab biosimilars as a viable and cost-effective alternative to Humira for managing rheumatoid arthritis. The results suggest that biosimilars can offer similar clinical benefits and improvements in patient-reported outcomes, potentially increasing access to treatment and reducing healthcare costs.
According to the study summary, individuals with rheumatoid arthritis who received either the adalimumab-adbm biosimilar or Humira experienced comparable improvements in symptoms and similar levels of side effects. These effects translated into highly similar, clinically meaningful improvements in experience and perception. Furthermore, a high proportion of participants in the trial reported greater improvements compared to a reference US population similar in age and sex, representing the attainment of a treatment goal that was difficult to achieve in early trials of non-biologic treatments for rheumatoid arthritis.
