Adalimumab biosimilar SB5 shows high persistence, no new safety signals through 48 weeks
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Key takeaways:
- The only characteristic associated with SB5 discontinuation was female sex.
- Most patients were able to remain on SB5 for the duration of follow-up.
Patients receiving the adalimumab biosimilar SB5 demonstrated high persistence, consistent effectiveness and no new safety signals through 48 weeks, according to data published in BioDrugs.
“SB5 was granted European Medicines Agency approval in August 2017 for the same indications as reference adalimumab, and became available for prescription in Europe in October 2018,” Ulf Müller-Ladner, MD, of Justus-Liebig University Giessen, in Germany, and colleagues wrote. “Transitioning from reference adalimumab to SB5 had previously been evaluated in a randomized controlled trial setting with narrow eligibility criteria in a single indication (RA); long-term, real-world evidence in representative populations is needed.”
To investigate the real-world outcomes of patients switching from originator adalimumab (Humira, AbbVie) to the biosimilar SB5 (Imraldi, Samsung Bioepis), Müller-Ladner and colleagues conducted PROPER, a non-interventional, single-cohort study conducted in specialist clinics throughout Germany, Spain, Italy, the United Kingdom, Belgium and Ireland. The study included patients with a confirmed diagnosis of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, Crohn’s disease or ulcerative colitis who were aged 18 years or older at the time of SB5 initiation.
Included patients had been transitioned to SB5 following at least 16 weeks of adalimumab use. Patients were assessed approximately every 3 months for a total follow-up of 48 weeks after switching to SB5. The researchers analyzed potential predictors for SB5 persistence measured in weeks, including sex, medical history, age at SGB5 initiation, relevant concomitant therapy and disease duration, activity and severity at baseline.
The analysis included 955 patients, of whom 207 had RA, 127 had axial SpA, 162 had PsA, 447 had Crohn’s disease and 12 had ulcerative colitis. A total of 932 patients completed follow-up, while 722 — or 75.6% — continued to receive SB5 through 48 weeks. Based on Kaplan-Meier estimates, the persistence of SB5 at 48 weeks was 0.86 (95% CI, 0.8-0.9) among patients with RA, 0.8 (95% CI, 0.71-0.86) among those with axial SpA, 0.81 (95% CI, 0.74-0.86) in patients with PsA and 0.72 (95% CI, 0.67-0.76) in those with Crohn’s disease.
According to the researchers, female sex was the sole predictor of therapy discontinuation. This was true in the RA (HR = 3.53; 95% CI, 1.07-11.67), axial SpA (HR = 2.38; 95% CI, 1.11-5.14) and Crohn’s disease (HR = 2.21; 95% CI, 1.54-3.18) cohorts. Disease activity scores remained “largely unchanged” throughout the study, the researchers wrote. Dosing regimen remained unchanged for most patients throughout the 48-week follow-up period.
“The findings of this pan-European study contribute to the overall understanding of real-world usage of SB5 in a large cohort of patients with established RA, axSpA, PsA, or CD transitioning from reference adalimumab, and demonstrate that SB5 is well tolerated and effective in these patients,” Müller-Ladner and colleagues wrote.
“Persistence on SB5 was high, with three-quarters of study patients remaining on treatment long term,” they added. “Of the candidate predictors identified (age, sex, comorbidities, disease duration, disease activity score, concomitant therapy), the only baseline variable associated with an increased risk of SB5 discontinuation was female sex, in patients with RA, axSpA, or CD.”
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