Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Komorbiditeter vid Icke-radiografisk axiell spondyloartrit

Komorbiditeter, rapporterade som tidigare existerande tillstånd hos åtminstone 5% av patienter från en klinisk prövning av ixekizumab i nr-axSpA tillhandahålls nedan.

Comorbid Conditions in COAST-V and COAST-W Ankylosing Spondylitis/Radiographic Axial Spondyloarthritis Clinical Trials

Around half of patients with AS/r-axSpA have comorbid conditions. A cross-sectional study found that the most common comorbid conditions, occurring in approximately 10% or more of AS patients, are coronary heart disease, anxiety, cancer, and hypertension. Compared with patients with nr-axSpA, patients with AS are more 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.2,3

Within the ixekizumab AS/r-axSpA phase 3 clinical development program, comorbidities (reported as preexisting conditions) that were reported in at least 5% of patients at baseline from COAST-V and COAST-W are listed in Table 1.

The phase 3 clinical trials were not designed to detect differences in the efficacy and safety of ixekizumab for the treatment of active AS in patients with or without specific comorbidities.4

Table 1. Most Common Comorbid Conditions Reported at Baseline in COAST-V and COAST-W Clinical Trials4

Comorbid Condition (MedDRA Preferred Term)ab

COAST-V
ITT Population
N=341
n (%)

COAST-W
ITT Population
N=316
n (%)

Arthritis

93 (27.3)

116 (36.7)

Enthesopathy

75 (22.0)

101 (32.0)

Hypertension

74 (21.7)

97 (30.7)

Dyslipidaemia

30 (8.8)

57 (18.0)

Osteoarthritis

32 (9.4)

14 (4.4)

Depression

6 (1.8)

28 (8.9)

Latent tuberculosis

23 (6.7)

22 (7.0)

Type 2 diabetes mellitus

9 (2.6)

21 (6.6)

Anxiety

6 (1.8)

20 (6.3)

Gastrooesophageal reflux disease

14 (4.1)

19 (6.0)

Psoriasis

20 (5.9)

34 (10.8)

Obesity

7 (2.1)

16 (5.1)

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 5.9% of patients from COAST-V and in 4.4% of patients from COAST-W at baseline.

a Reported as preexisting conditions at baseline of the clinical trials.

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, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753

3. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9

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

Glossary

AS = ankylosing spondylitis

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

nr-axSpA = nonradiographic axial spondyloarthritis

Datum fӧr senaste ӧversyn 2019 M08 30


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