Introduction

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic condition marked by inflammation and damage to the sacroiliac joints and spine, leading to inflammatory back pain, disability, and a reduction in quality of life.

Aim

To determine 6-month & 12-month secukinumab effectiveness in patients with axSpA

Patient Profile

• Patients (>18 years old), with axSpA initiating secukinumab
• Previous b/tsDMARD treatment included the TNFis adalimumab, etanercept, infliximab, golimumab and certolizumab, the costimulatory inhibitor abatacept, the anti- B-cell agent rituximab, the interleukin (IL)-12/IL-23 inhibitor ustekinumab, the IL-6 receptor inhibitor tocilizumab, the IL-1 receptor inhibitor anakinra and the tsDMARDs apremilast, baricitinib and tofacitinib

Methods

• N=1860 patients
• Data from 13 European registries within the European Spondyloarthritis Research Collaboration Network (EuroSpA) were aggregated for analysis

Study outcomes

• The main outcome measured was the overall retention rate of secukinumab at 12 months. Secondary outcomes included the 6-month retention rate of secukinumab, as well as the rates of inactive disease, low disease activity (LDA), and response at both 6 and 12 months.
• Primary and secondary outcomes were compared across
  • number of previous b/tsDMARDs (0/1/=2)
  • time since diagnosis (<2/2–4/>4 years)
  • the different European registries

Results

• Secukinumab retention rates after 6 and 12 months of treatment were high

Figure 1: Secukinumab drug retention overall and compared by previous b/tsDMARD treatment

• Patients who had used one previous b/tsDMARD or two or more previous b/tsDMARDs were at higher risk of discontinuing secukinumab before 12 months of treatment compared with b/tsDMARD-naïve patients (HR 1.78 & HR 2.33, respectively)
• A higher number of patients (n=326) discontinued secukinumab due to loss of efficacy compared to those withdrawing due to adverse events (n=110).
• Drug retention was independent of the duration since diagnosis, with no significant differences among patients diagnosed for <2 years, 2–4 years, and >4 years.
• Secukinumab retention rates at 6 and 12 months exhibited significant variability among different countries participating in EuroSpA.

Table 1: Inactive disease, LDA and response rates after 6 and 12 months of secukinumab treatment

	6 months	12 months
Crude/LUNDEX-adjusted BAS DAI<2	26%/21%	25%/16%
Crude/LUNDEX-adjusted BASDAI<4	51%/40%	51%/ 32%
crude/LUNDEX-adjusted ASDAS inactive disease	9%/7%	11%/ 7%
ASDAS low disease activity	24%/19%	27%/17%
BASDAI50 response	53%	47%
ASAS20 response	40%	37%
ASAS40 response	28%	22%
ASDAS CII	49	46
ASDAS-MI	25	26

ASAS20/40, Assessment of Spondyloarthritis International Society 20/40 response; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-CII, ASDAS clinically important improvement (=1.1); ASDAS-MI, ASDAS major improvement (=2.0); ASAS20/40, Assessment of Spondyloarthritis International Society 20/40 response; b/tsDMARD, biologic/targeted synthetic disease-modifying antirheumatic drug; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50, at least 50% improvement in BASDAI score or an absolute change of 2 (on a 0–10 scale)

Disease states and response rates in relation to the number of prior b/tsDMARDs used

• Crude and LUNDEX-adjusted rates of inactive disease, LDA & treatment responses after 6 and 12 mos differed significantly based on the number of prior b/tsDMARDs used (all p=0.002).
• Effectiveness decreased with an increasing number of previous b/tsDMARDs, with bionaïve patients exhibiting the highest rates overall

Rates of inactive disease, LDA & Response Based on the Duration Since diagnosis

• Response rates & disease states at 6 & 12 mos showed no significant differences among patients based on time since diagnosis (<2 years, 2–4 years, and >4 years), except for the achievement of BASDAI scores of <2 and <4, which did differ at the 6-month mark

Disease states & response rates across the European Registries

Disease states & response rates after 6 & 12 mos of treatment varied significantly across the registries in EuroSpA, except for ASDAS inactive disease

Conclusion

This study demonstrated that secukinumab retention rates after 6 and 12 months of treatment were high.Secukinumab consistently exhibited greater effectiveness in bionaïve patients, regardless of the time since diagnosis, and showed variations across different European countries.

Reference

RMD Open 2020 ;6: e001280