gms | German Medical Science

Background: Secukinumab (SEC) has been shown to be an effective treatment for patients (pts) with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in several phase III studies [1], [2]. Clinical studies reduce confounding factors, but do not guarantee the same results in real world where treating physicians deal with comorbidities, adherence and persistence challenges. Especially medication adherence has a direct impact on health outcomes. However, there is limited information on the adherence and persistence of SEC in routine care.

Objectives: The aim of this interim analysis is to report baseline (BL) characteristics and to assess adherence rate as well as treatment persistence of SEC in AS and PsA pts under real world conditions.

Methods: AQUILA is an ongoing, non-interventional study enrolling 2000 pts with active AS or PsA in Germany. Adherence was calculated as the proportion of the accumulated actual dose divided by the accumulated target dose (according to summary of product characteristics) during the maintenance phase (week 6 to 52). Adherence rate was calculated as the proportion of pts who achieved an adherence of >80% at wk 52. These calculations included pts who discontinued treatment with SEC; still ongoing pts were excluded from this interim analysis. Treatment persistence (time from study inclusion, i.e. date of informed consent, until treatment discontinuation) stratified by biologic/biosimilar (Bx) pretreatment was analyzed using Kaplan-Meier plots.

Results: This interim analysis describes 952 pts (AS n=311, PsA n=641) who were included at BL. In total, 51.4% (n=489) of the pts were female and 48.6% (n=463) male, mean age was 50.8 years, and 67.8% (n=645) were pretreated with Bx. At treatment start with SEC, pts presented with a number of extra-articular manifestations/comorbidities: plaque psoriasis 11.6% (n=36) in AS and 66.3% (n=425) in PsA, uveitis 6.4% (n=20) in AS and 1.7% (n=11) in PsA, depression 15.4% (n=48) in AS and 15.4% (n=99) in PsA, coronary heart disease 3.5% (n=11) in AS and 7.9% (n=51) in PsA, stroke 0.6% (n=2) in AS and 1.9% (n=12) in PsA, and heart insufficiency 1.6% (n=5) in AS and 3.0% (n=19) in PsA.

Adherence rates for SEC [95% CI] at week 52 were 64.5% [58.3,70.5] and 56.0% [51.5; 60.4] for AS and PsA, respectively.

In both AS and PsA, more Bx-pretreated pts discontinued treatment than Bx-naïve pts (AS: 38.0% versus 18.9%; PsA: 32.3% versus 20.7%). The most frequent reason for discontinuation was “adverse event/insufficient response/loss of efficacy” in both Bx-pretreated (n=73, 33.0%/n=111, 26.2%) as well as in Bx-naïve (n=10, 11.1%/n=34, 15.7%) AS/PsA pts. Moreover, Kaplan-Meier analysis showed that in both AS (Figure 1 [Fig. 1]) and PsA (Figure 2 [Fig. 2]) groups, Bx-naïve pts who received SEC as first line therapy had a higher persistence rate than those pretreated with Bx.

Conclusion: AQUILA study revealed high disease burden at BL across AS and PsA pts characterized by the presence of extra-articular manifestations and cardiovascular diseases. Adherence rates under real-world conditions were consistent and comparable with published literature regarding immune-mediated inflammatory diseases [3]. SEC demonstrated a high drug persistence in real world in particular in Bx-naive pts.

Overall, this interim analysis demonstrated that SEC is a reliable treatment in Bx-naïve as well as Bx-pretreated pts with AS or PsA in a daily routine setting.