Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz®▼ (ixekizumab): Comorbidities in Phase 3 Nonradiographic Axial Spondyloarthritis Trial

Comorbidities, reported as preexisting conditions, in at least 5% of patients from a clinical trial of ixekizumab in nr-axSpA are provided.

Comorbid Conditions in COAST-X Trial in Patients with Nonradiographic Axial Spondyloarthritis

A cross-sectional study found that the most common comorbid conditions, occurring in approximately 10% or more of nr-axSpA patients, were coronary heart disease, anxiety, cancer, hypertension, and depression. Nonradiographic axSpA patients had similar comorbidity burdens as those with AS/r-axSpA. Compared with patients with AS/r-axSpA, patients with nr-axSpA were less likely to also have psoriasis.1

In ixekizumab clinical trials, patient comorbidities were required to be controlled so as not to pose an unacceptable risk to a patient if participating in the study. Patients were excluded if they had the presence of significant uncontrolled disorders at screening that, in the opinion of the investigator, posed an unacceptable risk. Patients with current or a history of lymphoproliferative or malignant disease within 5 years of randomization and patients with a serious infection within 12 weeks prior to randomization were also excluded.2

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.2

In the COAST-X clinical trial in patients with nr-axSpA, comorbidities (reported as preexisting conditions) reported in at least 5% of patients at baseline are listed in Table 1.

COAST-X was not designed to detect differences in the efficacy and safety of ixekizumab for the treatment of active nr-axSpA in patients with or without specific comorbidities.3

Table 1. Most Common Comorbid Conditions Reported at Baseline (Reported in ≥5% of Patients) in COAST-X3

Comorbid Condition (MedDRA Preferred Term)ab

ITT Population
N=303
n (%)

Arthritis

150 (49.5)

Enthesopathy

124 (40.9)

Hypertension

64 (21.1)

Dyslipidaemia

34 (11.2)

Osteoarthritis

25 (8.3)

Psoriasis

23 (7.6)

Gastrooesophageal reflux disease

20 (6.6)

Latent tuberculosis

19 (6.3)

Depression

18 (5.9)

Psoriatic arthropathy

18 (5.9)

Seasonal allergy

18 (5.9)

Hypothyroidism

17 (5.6)

Drug hypersensitivity

17 (5.6)

Arthralgia

16 (5.3)

Gastritis

15 (5.0)

Abbreviations: ITT = intent-to-treat; MedDRA = Medical Dictionary for Regulatory Activities.
NOTE: Drug hypersensitivity, while not generally considered to be a comorbidity, was reported as a preexisting condition in 5.6% of patients at baseline.

a Reported as preexisting conditions at baseline.

b Consists of patients across all treatment arms combined.

References

1. Zhao SS, Ermann J, Xu C, et al. Comparison of comorbidities and treatment between ankylosing spondylitis and non-radiographic axial spondyloarthritis in the United States [published online May 12, 2019]. Rheumatology (Oxford). http://dx.doi.org/10.1093/rheumatology/kez171

2. 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

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

nr-axSpA = nonradiographic axial spondyloarthritis

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: November 25, 2019


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