Radiographic Progression Low for High-Risk Patients With axSpA on Both Secukinumab and an Adalimumab Biosimilar

Both secukinumab and an adalimumab biosimilar reduce inflammation at a similar rate and have low spinal radiographic progression in patients at high risk for radiographic axial spondyloarthritis (r-axSpA) disease progression, according to a recent head-to-head comparison of the biologic agents published in Clinical Drug Investigation.¹

Common symptoms of axial spondyloarthritis are inflammatory back pain, stiffness, and structural damage.

Image credit: WavebreakMediaMicro - stock.adobe.com

AxSpA is a chronic inflammatory condition primarily affecting the axial skeleton. It is characterized by inflammatory back pain, stiffness, and structural damage. Effective management of axSpA is essential to minimize disease progression, as indicated by new bone formation and joint damage. This condition represents a significant concern, as it can lead to disability and a reduced quality of life.

Evidence suggests that biologic agents, such as IL-17A inhibitors like secukinumab, and tumor necrosis factor inhibitors, including adalimumab and its biosimilars, are associated with low rates of radiographic progression. However, comparative data on the impact of biologic disease-modifying antirheumatic drugs on radiographic progression are limited. The intent of the SURPASS trial design was to address this knowledge gap.²

SURPASS is a phase IIIb, randomized, head-to-head study evaluating the effect of secukinumab and adalimumab biosimilar on radiographic progression in patients with moderate to severe active r-axSpA over 2 years. To date, this is the first head-to-head study comparing 2 different biologic treatments on radiographic progression in a high-risk r-axSpA population. The study's primary end point was the proportion of patients with no radiographic progression after 2 years.

The SURPASS study enrolled 859 adults with radiographic evidence of r-axSpA and no prior biologic treatment. They were randomly assigned to receive either secukinumab at a dose of 150 mg or 300 mg every 4 weeks, following loading doses at baseline and weeks 1, 2, 3, and 4, or adalimumab biosimilar 40 mg every 2 weeks.

Baseline disease characteristics and patient demographics were balanced across all groups. The majority of the patients were male (78.5%), with a mean age of 42.1 years. Former or current smokers made up approximately half of the population (47.1%).

The study enrolled patients with a high risk for radiographic progression, which was defined as having a high-sensitivity C-reactive protein (hsCRP) ≥ 5 mg/L and/or ≥ 1 syndesmophyte(s) on spinal radiographs.³ At baseline, 73% of the patients had syndesmophyte(s), 76% had hsCRP level ≥ 5 mg/L, and 54% had both syndesmophyte(s) and hsCRP level ≥ 5 mg/L.

The results showed no significant difference in radiographic progression (change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score ≤ 0.5) between the groups at week 104, with progression-free rates of 66.1%, 66.9%, and 65.6% in the secukinumab 150 mg, 300 mg, and adalimumab biosimilar arms, respectively.

Researchers also observed that, overall, just over half of the patients in each group with at least one syndesmophyte did not develop a new one, with rates of 56.9% and 53.8% for patients treated with secukinumab 150 mg and 300 mg and 53.3% for patients treated with adalimumab biosimilar.

Secondary end points for spine and sacroiliac joints and spine MRI scores, edema score, and safety were all comparable between treatment groups.

Both treatments had similar safety outcomes consistent with those reported previously, with adverse event rates of 80.8%, 79.7%, and 84.2%, respectively, for patients treated with secukinumab 150 mg, 300 mg, or adalimumab biosimilar 40 mg, respectively.

"The lack of statistically significant difference in progression observed between the two biologic treatments during the 2-year period indicates that both target pathways are critical to radiographic progression in patients with r-axSpA,” the authors concluded.

References

1. Baraliakos X, Østergaard M, Poddubnyy D. Effect of secukinumab versus adalimumab biosimilar on radiographic progression in patients with radiographic axial spondyloarthritis: Results from a head-to-head randomized phase IIIb study. Arthritis & Rheumatology. doi:10.1002/art.42852

2. Baraliakos X, Østergaard M, Gensler LS, et al. Comparison of the effects of secukinumab and adalimumab biosimilar on radiographic progression in patients with ankylosing spondylitis: design of a randomized, phase IIIb study (SURPASS). Clin Drug Investig. 2020;40(3):269-78. doi:10.1007/s40261-020-00886-7

3. Poddubnyy D, Sieper J. Radiographic progression in ankylosing spondylitis/axial spondyloarthritis: how fast and how clinically meaningful? Curr Opin Rheumatol. 2012;24(4):363-9. doi:10.1097/BOR.0b013e328352b7bd