Real-World Results and Long-Term Safety Data for Secukinumab

Secukinumab (Cosentyx) was first approved in the United States and the European Union for use in psoriasis in 2015, and it has since been approved for use in ankylosing spondylitis (AS). An abstract presented at the European Congress of Rheumatology of the European League Against Rheumatism (EULAR) reviewed longer-term safety data for the use of secukinumab in AS, psoriasis, and psoriatic arthritis.¹

The researchers analyzed a clinical trial safety dataset using data from 28 randomized controlled trials, as well as postmarketing safety surveillance. A total of 12637 patients were included: 8819 had psoriasis, 2678 had psoriatic arthritis, and 1140 had AS. The safety data was for up to 5 years.

Upper respiratory tract infection was the most frequent adverse event (AE) and the exposure-adjusted incident rates per 100 patient-years was low for inflammatory bowel disease (IBD), malignancies, and major adverse cardiac events.

“In conclusion, this long-term analysis across clinical trials and postmarking surveillance showed that secukinumab was well-tolerated with a safety profile consistent with previous reports,” said Atul Deodhar, MD, MRCP, a professor at Oregon Health & Science University, during his presentation of the poster for EULAR.

In a second abstract, researchers evaluated the effectiveness and safety of secukinumab in patients with AS and psoriatic arthritis in a real-life setting.²

They collected data from 168 consecutive outpatients between September 2018 and September 2019. Data were collected at baseline and at 6 months and 12 months after patients started secukinumab. Thirty-nine (23%) of the patients had AS and 129 (77%) had psoriatic arthritis.

The researchers saw significant improvement at both 6 and 12 months for clinical variables including tender joint count, swollen joint count, C-reactive protein (CRP), disease activity in psoriatic arthritis, and Bath Ankylosing Spondylitis Disease Activity Index. They also noted significant improvement in Visual Analog Scale for Pain, a patient-reported outcome.

One-year drug survival was 76.4% and 40 patients (23.7%) discontinued therapy before the end of the first year. Among AS, male patients had a higher persistence rate, but there was no difference among patients with psoriatic arthritis. The researchers also found no differences in drug survival according to body mass index, lines of treatment, smoking, comorbidities, diagnostic delay and CRP positivity.

Overall, the therapy was well tolerated, according to the evaluation. Only 11 patients discontinued treatment for non-severe AEs. One patient discontinued for new-onset IBD, 5 patients for allergy/intolerance, 1 for pulmonary nodule evaluation, 3 for infectious diseases, and 1 for increase in transaminases.

“Secukinumab’s effectiveness was confirmed in real-life settings and also a good safety profile of the drug was confirmed,” Maria Sole Chimenti, MD, PhD, associate professor at the University of Rome Tor Vergata, said during her presentation of the poster for EULAR.

References

1. Deodhar A, Mcinnes I, Baraliakos X, et al. Secukinumab demonstrates a consistent safety profile in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis over long term: updated pooled safety analyses. Presented at: EULAR 2020; June 3-6, 2020; Abstract FRI0272.

2. Chimenti MS, Fonti GL, Conigliaro P, et al. One-year effectiveness, retention rate and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicentre study. Presented at: EULAR 2020; June 3-6, 2020; Abstract FRI0270.