Cosentyx shows safety, efficacy over 1 year in real-world AS study
Disease remission more likely for men than women with therapy
One year of treatment with Cosentyx (secukinumab) showed safety and efficacy in a real-world study conducted in Italy, lowering disease activity among people with ankylosing spondylitis (AS) and psoriatic arthritis (PsA).
Men were overall more likely than women to achieve disease remission after a year of treatment.
“This study supports a high effectiveness and tolerability profile for [Cosentyx] in the real-life management of patients with AS or PsA,” the researchers wrote, noting, however, a need to further investigate the role of sex in treatment responses.
“Our study confirms, in the whole [group] of patients with AS or PsA, the disadvantageous role of female sex in drug survival and in achieving inactive disease or clinical remission … with [Cosentyx] after one year of follow-up,” the team wrote.
The study, “Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort,” was published in Advances in Rheumatology.
Cosentyx shows efficacy, safety in both AS and PsA
AS and PsA are forms of spondyloarthritis, a family of diseases that involve inflammation and musculoskeletal pain affecting the spine or other joints. While AS is predominately an axial disease, meaning it affects the spine and pelvis, PsA is mostly peripheral, affecting joints other than the spine.
Novartis’ Cosentyx is an antibody-based treatment approved for both AS and PsA that targets interleukin-17A, a signaling molecule that drives inflammation in these diseases. Its approvals were backed by clinical trial data that found that the therapy, given as an under-the-skin (subcutaneous) injection, significantly reduced disease activity in these patient populations.
“An important goal is to confirm its effectiveness and tolerability profile in the real-life management of these patients, and to investigate patient adherence to treatment,” the researchers wrote.
To that end, the Italy-based team retrospectively examined real-world data from 85 adults with AS and PsA, seen at an Italian clinic, who were treated with Cosentyx between December 2017 and December 2019.
A total of 29 patients had AS and 56 had PsA; all had moderate to severe disease activity despite previous treatments. Among those with AS, 20 (69%) were women and the mean age was 50.5 years.
AS patients received Cosentyx’s approved regimen: an under-the-skin injection (150 mg) once per week for five consecutive weeks, followed by a monthly maintenance injection thereafter.
They were followed for up to one year, and the study’s main outcome was to assess changes in the ankylosing spondylitis disease activity score using C-reactive protein (ASDAS-CRP). This is a measure of disease activity that takes into account blood levels of an inflammatory molecule that’s elevated in AS; higher scores indicate more severe disease.
Continuous, significant reductions in disease activity scores were observed throughout follow-up, dropping from a mean of 3.7 at the study’s start — reflecting very high disease activity — to 2.8 after eight weeks, indicative of high disease activity.
By week 24, or about six months, the mean ASDAS-CRP score was 1.7, representing low disease activity. After a year, the observed mean score of 1.3 represented sustained low disease activity, or early inactive disease, according to the researchers.
After a year of treatment, 65.5% of AS patients had achieved inactive disease, according to the ASDAS-CRP.
PsA patients saw comparable reductions in disease activity, measured using a similar assessment, over a year of treatment.
For both patient groups, those with the highest disease activity at study’s start saw the greatest reductions in disease activity. Elevated body weight also was found to have a modest, negative impact on Cosentyx’s effectiveness after a year in AS patients.
Moreover, being a man emerged “as a strong independent predictor of achievement of inactive disease or remission,” the team wrote, being associated with a five times higher likelihood of attaining such positive outcome relative to being a woman.
This finding, consistent with previous studies, “deserves further attention,” the team wrote. Still, they added that the “overall extent of disease activity score reductions did not substantially differ” between men and women.
Our study confirms, in the whole [group] of patients with AS or PsA, the disadvantageous role of female sex in drug survival and in achieving inactive disease or clinical remission … with [Cosentyx] after one year of follow-up.
Also, treatment responses were generally similar between patients who had been previously treated with tumor necrosis factor inhibitors and those who had not.
Overall, 75% of study participants remained on treatment after a year, with 21 people stopping early due to inadequate disease control. The highest dropout rate was observed among female AS patients (40%).
The therapy was generally well-tolerated.
“Only 4 patients (5%) experienced mild local reactions at the injection site,” the team wrote, noting that no patients stopped treatment due to side effects.
Altogether, the findings provide “considerable real-world information and interesting insights” related to Cosentyx’s use in AS and PsA, the researchers wrote. Larger and longer studies are needed to confirm the findings, they said.
