gms | German Medical Science

Background: AS has adverse effects on an individual’s health status [1]. Secukinumab, (IL-17A inhibitor) improved signs, symptoms and patient-reported outcomes (PROs) over 52 wks in the randomised, double-blind, PBO-controlled, Phase 3 MEASURE 1 study [2], [3].

Objectives: To evaluate the effect of secukinumab on disease activity, pain, physical function, fatigue, and general and AS-specific quality of life (QoL) measures over 104 wks.

Methods: 371 adults with active AS were randomised to receive secukinumab 10 mg/kg i.v. at BL, Wks 2 and 4, and then s.c. 150 mg (IV→150 mg) or 75 mg (IV→75 mg) every 4 wks from Wk 8, or PBO. At Wk 16, PBO-treated pts were re-randomised to receive secukinumab 150 mg or 75 mg from Wk 16 (non-responders) or Wk 24 (responders). PROs assessed included: BASDAI; Short Form Health Survey physical health component summary score (SF-36 PCS) and SF-36 mental health component summary score (SF-36 MCS);ASQoL; patient’s global assessment of disease activity; patient’s assessment of total spinal pain; patient’s assessment of nocturnal pain; BASFI; FACIT-Fatigue; and EQ-5D. BASDAI, SF-36 PCS and ASQoL were predefined secondary endpoints and are reported using a mixed-effect model repeated measures analysis. Other PROs and analyses by prior anti-TNF therapy use were exploratory endpoints and are reported as observed data.

Results: 97/125 (77.6%) and 103/124 (83.1%) pts randomised to IV→150 mg and IV→75 mg, completed 104 wks of treatment. The improvements in BASDAI, SF-36 PCS and MCS, ASQoL, BASFI, and FACIT-Fatigue achieved at Wk 52 were sustained at Wk 104, with mean changes from BL being greater than minimum clinically important differences. Improvements were also observed in patient’s global assessment of disease activity, total spinal pain, nocturnal pain, and EQ-5D. Sustained improvements were observed regardless of prior anti-TNF use. In anti–TNF-naïve pts, mean changes with secukinumab IV→150 mg and IV→75 mg were: –3.5 and –3.1, for BASDAI; 8.4 and 7.4 for SF-36 PCS; and –5.0 and –4.4 for ASQoL. Corresponding changes in anti-TNF-IR pts, were: –3.2 and –2.9 (BASDAI); 6.9 and 7.6 (SF-36 PCS); –4.1 and –5.1 (ASQoL).

Table 1 [Tab. 1]

Conclusion: Secukinumab provided sustained improvements through 2 years in PROs including disease activity, pain, physical function, fatigue, as well as general and AS-specific measures of QoL.