Patients with ankylosing spondylitis taking secukinumab saw improvements in enthesitis, and some achieved complete resolution, suggesting the drug could be a viable option for patients intolerant of or unresponsive to other enthesitis-improving medications.
Secukinumab (Cosentyx) has been shown to improve enthesitis in patients with ankylosing spondylitis (AS), and some even achieved enthesitis remission, according to a recent study published in the Journal of Rheumatology.
The results of the ad hoc analysis provide evidence for the use of secukinumab in patients with AS who are unresponsive to or intolerant of other medications that can improve enthesitis, such as nonsteroidal anti-inflammatory drugs and anti–tumor necrosis factor drugs.
Enthesitis is common in AS and can cause patients significant pain, morning stiffness, fatigue, impaired physical function, and poor quality of life. It is often triggered by biomechanical stress or infection and if left untreated can lead to irreversible structural damage in patients with AS. Enthesitis is estimated to affect between 30% and 70% of patients with AS and is often underdiagnosed in routine practice.
Secukinumab has been shown to provide rapid and sustained enthesitis resolution in about 50% to 70% of patients with psoriatic arthritis. However, data on improvement or resolution of enthesitis in AS are limited.
The authors pooled data from 4 randomized placebo-controlled phase 3 studies (MEASURE 1-4) through 52 weeks that had data available by May 13, 2018. The patients were randomized to receive secukinumab 150 mg, secukinumab 300 mg, or a placebo. Patients’ Maastricht Ankylosing Spondylitis Enthesitis Scores (MASES) were used to assess enthesitis severity.
Patients with AS were eligible if they were 18 years or older and had prior documented radiological evidence for AS diagnosis, a score of 4 or higher on an AS severity scale, and a spinal pain score of 40 mm or higher on a 100 mm visual analog scale.
In total, 969 patients were included in the analysis, of whom 693 (71.5%) had enthesitis. Among the groups, 58 of the 76 (76.3%) patients in the 300 mg group, 355 of 504 (70.4%) of the patients in the 150 mg group, and 280 of 389 (72.0%) of the patients in the placebo group had enthesitis.
Women were more prevalent among the patients with enthesitis compared with patients without enthesitis (300 mg, 39.7% vs 16.7%; 150 mg, 39.2% vs 16.8%; placebo, 39.6% vs 19.3%, respectively).
After 16 weeks, the mean change from baseline in MASES for overall MASES was higher for patients treated with secukinumab 300 mg (–2.9; 95% CI, –1.84 to –0.31; P < .01) and 150 mg (–2.4; 95% CI, –0.96 to –0.11; P < .05) than placebo-treated patients (–1.9). Patients treated with secukinumab 300 mg (–2.9; 95% CI, –1.76 to –0.35; P < .01) and 150 mg (–2.3; 95% CI, –0.89 to –0.10; P < .05) also had higher changes in MASES for axial entheseal sites compared with the control group (–1.8).
The MASES at Achilles tendon and peripheral entheseal sites improved but were not significant for secukinumab-treated patients. However, patients treated with a placebo did show significant improvement.
“Whether these results are due to ankylosing spondylitis being predominantly an axial disease, the limitations of assessments using MASES, and/or because of higher than expected placebo responses requires further research,” wrote the authors.
MASES score improvements continued through week 52, with patients treated with 300 mg secukinumab exhibiting a numerically higher response than those treated with 150 mg for the overall MASES (–3.9 vs –3.5), axial entheseal sites (–3.6 vs –3.2), and Achilles tendon and peripheral entheseal sites (–2.1 vs –1.9), respectively.
Additionally, more than one-third of patients in both secukinumab treatment groups achieved complete resolution of enthesitis at week 16 (300 mg, 36.2%; 150 mg, 40.8%).
The post hoc nature of the study and the potential for the results to not be fully reflective of real-world clinical outcomes for secukinumab in this population were listed as study limitations. In addition, there was a lack of a long-term comparator because it is considered unethical to give a placebo to patients with AS for a prolonged period of time.
Schett G, Baraliakos X, Van den Bosch F, et al. Secukinumab efficacy on enthesitis in patients with ankylosing spondylitis: pooled analysis of four pivotal phase 3 studies. J Rheumatol. Published online June 1, 2021. doi:10.3899/jrheum.201111