This is a summary of the original article: ‘Effects of adalimumab-adbm versus adalimumab reference product on patient-reported outcomes in rheumatoid arthritis: Results from VOLTAIRE-RA’ [1].

What is Rheumatoid Arthritis?

  • Rheumatoid arthritis is a chronic, autoimmune, inflammatory disease with common symptoms that can include pain, physical function impairments, fatigue, and morning stiffness.

  • Progressive functional impairments can result in reduced health-related quality of life, impaired work productivity, and can make it difficult for patients to carry out daily activities.

  • Without appropriate long-term treatment, rheumatoid arthritis can lead to joint destruction, deformity, disability, and can even lead to reduced life expectancy.

  • Treatment with biologic medicines can help people to manage the symptoms of rheumatoid arthritis.

What is Adalimumab-adbm?

  • Adalimumab is a biologic medicine that is used to treat several conditions, including rheumatoid arthritis.

  • Adalimumab-adbm (brand name Cyltezo®) is an approved interchangeable biosimilar for the adalimumab reference product (brand name Humira®) in the United States.

  • Adalimumab-adbm and adalimumab reference product have structural similarity, are pharmacokinetically and clinically bioequivalent, and result in highly similar outcomes with respect to efficacy and safety.

What Did the VOLTAIRE-RA Study Look at?

  • In the VOLTAIRE-RA study, researchers wanted to find out how well adalimumab-adbm worked as a treatment for rheumatoid arthritis compared with the adalimumab reference product, and if the side effects people experienced were similar (Fig. 1).

  • The study included people with moderate to severely active rheumatoid arthritis who were taking methotrexate.

  • In the VOLTAIRE-RA study, people who received the biosimilar had similar side effects and reductions in symptoms as those who received the reference biologic and then switched to the biosimilar.

  • The results show that people with rheumatoid arthritis who received adalimumab-adbm could expect similar treatment outcomes to people who were treated with adalimumab reference product.

  • Because of the impact of rheumatoid arthritis on patient well-being, researchers also asked people to fill in a survey to look at the impact on their quality of life.

    • The short-form 36-item health survey questionnaire (SF-36) is a well-studied tool that can be used to assess patient-reported health status across eight domains: physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations, and mental health.

    • Outcomes for these domains can be combined to summarize as the physical component summary (PCS) and mental component summary scores (MCS).

    • Other patient-reported assessments included Patient’s Global Assessment of Disease Activity (PtGA), pain, and the Health Assessment Questionnaire-Disability Index (HAQ-DI).

  • This post hoc analysis provides a broad assessment of patient-reported outcomes in the first 24 weeks of the VOLTAIRE-RA study.

Fig. 1
figure 1

The VOLTAIRE-RA study

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What Were the Results of this Analysis?

  • The physical component summary and mental component summary scores reported were low in both treatment groups before they started treatment.

    • Bodily pain, physical functioning, role physical, general health, and vitality were all particularly low prior to treatment in this population.

  • At 12 and 24 weeks following the start of treatment, people in both treatment groups showed similar improvements in their physical and mental component summary scores that greatly exceeded the minimum clinically important difference (Fig. 2).

Fig. 2
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Proportion of patients reporting clinically significant improvements after 24 weeks of treatment

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• There were no differences in physical component summary scores between treatment groups at baseline or weeks 12 and 24

• Around 2 in 3 people reported clinically meaningful improvements in the physical component summary score in both treatment groups at weeks 12 and 24

• Over two-thirds of people reported clinically meaningful improvements in physical functioning, role physical, bodily pain, and vitality

• Over half reported improvements in general health, emotional role limitations, social functioning, and mental health domains

• Mental component summary scores were slightly higher in the reference product group at baseline, and differences in scores at weeks 12 and 24 generally reflected those differences

• However, improvements at weeks 12 and 24 were similar between treatments across all domains, with no clinically meaningful differences between treatment groups

• Clinically meaningful improvements in the MCS score were reported at weeks 12 and 24 in over half of the participants in both treatment groups

  • At baseline, 0–1% and 16–20% patients had SF-36 PCS and MCS scores, respectively, that exceeded US age- and sex-matched normative values specific to this protocol population.

    • By week 24, 11% patients reported scores ≥ normative values in PCS and 29–40% in MCS.

  • Over 24 weeks of treatment, large percentage improvements in patient-reported quality of life scores ≥ norms were evident across the SF-36 domains, with the exception of physical role and general health.

Other Patient-Reported Outcomes

  • Similar proportions of participants in both treatment groups reported clinically meaningful improvements in Patient’s Global Assessment of Disease Activity (Table 1).

  • Around five in ten participants (50–54%) reported clinically meaningful improvements in their Health Assessment Questionnaire-Disability Index

    • Seventeen percent of participants who received adalimumab-adbm and 19% who received adalimumab reference product had HAQ-DI scores at week 24 greater than those seen for age- and sex-matched members of the general US population.

Table 1 Proportion of participants showing improvement at week 12 and week 24
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What were the Main Conclusions Reported by the Researchers?

  • In the VOLTAIRE-RA study, the people with rheumatoid arthritis who received either adalimumab-adbm or the adalimumab reference product saw similar improvement in their symptoms and experienced similar levels of side effects.

  • These translated into highly similar clinically meaningful improvements in experience and perception.

  • In patients with moderate to severely active rheumatoid arthritis, adalimumab-adbm and adalimumab reference product were both associated with similar substantial benefits across a range of patient-reported outcomes.

  • Improvements in physical and mental component summary scores, as well as in the individual domain scores, were highly similar for the two treatment groups at 12 weeks and 24 weeks after starting treatment.

  • The high proportion of participants reporting scores similar to those expected for a US population of similar age and sex after 24 weeks in both treatment groups represents attainment of a treatment goal that was difficult to achieve in early trials of non-biologic treatments for rheumatoid arthritis.