Taltz® (ixekizumab): Hur många patienter avbröt den icke-radiografiska axiella spondyloartritstudien? Vilka var orsakerna till avbrottet?

Discontinuations in COAST-X

COAST-X (N=303) is a phase 3, 52-week double-blind, placebo-controlled trial in patients with nr-axSpA who are naive to bDMARDs.¹

Reported reasons for discontinuation of study drug in patients that remained in their original treatment arm is shown in Table 1.

Table 1. Reasons for Discontinuation of Study Drug Through Week 52 of COAST-X, Prior to any Switch to Open-Label Ixekizumab Every 2 Weeks¹

Abbreviations: AE = adverse event; ALT = alanine aminotransferase; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.

^a AEs were ALT increased and anaphylactoid reaction.

^b AE was psoriasis.

^c AE was syncope.

 The dosing schedule IXE Q2W is not consistent with the approved dosing schedule for axial spondyloarthritis in the Taltz Summary of Product Characteristics. Please refer to the Taltz Summary of Product Characteristics for approved dosing.²

Starting at week 16 of the COAST-X trial, patients whose disease activity required escalation of treatment could be switched to open-label ixekizumab 80 mg Q2W or subsequent anti-TNF therapy (after a minimum of 8 weeks of open-label ixekizumab treatment) at the discretion of the treating rheumatologist without further specification. The proportions of patients in each treatment arm who switched to open-label ixekizumab 80 mg Q2W were

• 62/105 (59%) in the placebo arm

• 40/96 (42%) for the ixekizumab Q4W arm, and

• 42/102 (41%) for the ixekizumab Q2W arm.¹

Reported reasons for discontinuation of patients who switched to open-label ixekizumab 80 mg Q2W after week 16 are shown in Table 2. Of 144 total patients who switched to open-label ixekizumab treatment, 127 patients (88.2%) remained on open-label ixekizumab treatment through week 52.¹

Table 2. Reasons for Discontinuation of Study Drug Through Week 52 of COAST-X, After Switch to Open-Label Ixekizumab Every 2 Weeks¹

Abbreviations: AE = adverse event; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.

^a AEs were C. difficile infection, injection site erythema, and injection site reaction.

^b AE was suicidal ideation.

References

1. Deodhar A, van der Heijde D, Gensler LS, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

2. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

nr-axSpA = nonradiographic axial spondyloarthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

TNF = tumor necrosis factor