{Reference Type}: Journal Article
{Title}: A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment.
{Author}: Deodhar A;Kivitz AJ;Magrey M;Walsh JA;Mease PJ;Greenwald M;Kianifard F;Elam C;Bommidi GM;Winseck A;Gensler LS;
{Journal}: Rheumatology (Oxford)
{Volume}: 0
{Issue}: 0
{Year}: 2024 Aug 12
{Factor}: 7.046
{DOI}: 10.1093/rheumatology/keae432
{Abstract}: <B>OBJECTIVE: </B>To investigate the clinical response at week 52 in patients with ankylosing spondylitis (AS) who received secukinumab 300 vs 150 mg after inadequate response to 150 mg at week 16.<BR><B>METHODS: </B>ASLeap (NCT03350815) was a randomized, double-blind, parallel-group, multicentre, phase 4 trial. After 16 weeks of open-label secukinumab 150 mg (Treatment Period 1), patients who did not achieve inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] <1.3) at both Weeks 12 and 16 were considered to have an inadequate response and were randomized 1:1 to receive secukinumab 300 or 150 mg every 4 weeks until week 52 (Treatment Period 2). The primary efficacy variable was achievement of ASDAS <1.3 at week 52 using week 16 as baseline. Safety was evaluated by the incidence of treatment-emergent adverse events through week 52.<BR><B>RESULTS: </B>Of 322 patients treated with secukinumab in Treatment Period 1, 207 (64.3%) had inadequate response. Similar proportions of patients with inadequate response randomized to secukinumab 300 mg (n = 101) and 150 mg (n = 105) in Treatment Period 2 completed the study (83.8% and 84.3%, respectively). At week 52, 8.8% and 6.7% of patients receiving secukinumab 300 and 150 mg, respectively, achieved ASDAS <1.3. The incidence of treatment-emergent adverse events was similar in both groups through week 52. No new safety signals were observed.<BR><B>CONCLUSIONS: </B>Patients with AS who did not achieve ASDAS <1.3 after receiving secukinumab 150 mg for 16 weeks experienced similar clinical response and safety through week 52 regardless of dose escalation.<BR><B>BACKGROUND: </B>ClinicalTrials.gov, NCT03350815.