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 Psoriatic Arthritis Clinical Trials

Comorbidities reported in at least 5% of patients from SPIRIT-P1 and SPIRIT-P2 are provided.

Psoriatic Arthritis Clinical Trials

Within the ixekizumab PsA phase 3 clinical development program, comorbidities (reported as preexisting conditions) that were reported in at least 5% of patients at baseline from either SPIRIT-P1 or SPIRIT-P2 are listed in Table 1.

SPIRIT-P1 is a study assessing efficacy and safety of ixekizumab compared to placebo in patients with active PsA who are naive to bDMARDs.1

SPIRIT-P2 is a study assessing efficacy and safety of ixekizumab compared to placebo in patients with active PsA who had inadequate response or intolerance to TNF-inhibitors.2

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, such as

  • cerebro-cardiovascular

  • respiratory

  • hepatic

  • renal

  • gastrointestinal

  • endocrine

  • hematologic

  • neurologic, or

  • neuropsychiatric.1,2

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

Comorbidities at Baseline

Table 1. Most Common Comorbid Conditions Reported at Baseline in SPIRIT-P1 and SPIRIT-P2 Clinical Trials3

Comorbid condition n(%) ab

SPIRIT-P1 (N=417)

SPIRIT-P2 (N=363)

Hypertension

151 (36)

151 (42)

Depression

42 (10)

78 (22)

Osteoarthritis

49 (12)

53 (15)

Diabetes mellitus

46 (11)

53 (15)

Gastroesophageal reflux disease

31 (7)

59 (16)

Seasonal allergy

28 (7)

44 (12)

Hyperlipidemia

29 (7)

42 (12)

Hypothyroidism

33 (8)

34 (9)

Anxiety

23 (6)

39 (11)

Hypercholesterolemia

21 (5)

37 (10)

Insomnia

16 (4)

39 (11)

Asthma

26 (6)

24 (7)

Obesity

17 (4)

33 (9)

Migraine

13 (3)

26 (7)

Osteoporosis

14 (3)

19 (5)

Fatigue

10 (2)

22 (6)

Hepatic steatosis

10 (2)

22 (6)

Sleep apnea syndrome

5 (1)

21 (6)

Note: Drug hypersensitivity, while not generally considered to be a comorbidity, was reported as a preexisting condition in 10% of patients from SPIRIT-P1 and 11% of patients from SPIRIT-P2 at baseline.

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

b Consists of patients across all treatment arms combined.

A recent registry study in Denmark found that compared to a reference population, patients with PsA have a higher prevalence of

  • cardiovascular disease (15.5% vs 8.7%)

  • alcohol abuse (1.8% vs 1.4%)

  • smoking (16.3% vs 9.9%), and

  • hypertension (21.2% vs 12.1%).4

The study also found that there was an increased risk of MI associated with longer duration of PsA (HR = 1.02 for each additional year after PsA diagnosis, adjusted for age, sex, socio-economic status, cholesterol-lowering drugs, smoking, alcohol abuse, diabetes, hypertension and previous cardiovascular disease).4

Background information regarding Psoriatic Arthritis Clinical Trials

Ixekizumab was assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints).

Patients had

  • a diagnosis of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 5.33 years and

  • had current plaque psoriasis skin lesions (94.0%) or

  • a documented history of plaque psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline.5

Over 58.9% and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively.5

Primary endpoint of both studies was American College of Rheumatology (ACR) 20 response at week 24, followed by a long‑term extension period from Week 24 to Week 156 (3 years).5

References

1. Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

2. Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

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

4. Egeberg A, Skov L, Hansen PR, et al. Duration of psoriatic arthritis as a risk factor for myocardial infarction. Rheumatol Adv Pract. 2018;2(1):rky011-rky011. http://dx.doi.org/10.1093/rap/rky011

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

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

HR = hazard ratio

MI = myocardial infarction

PsA = psoriatic arthritis

TNFi = tumor necrosis factor inhibitor

Date of Last Review: September 28, 2018


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 10am - 4pm, excluding Bank Holidays

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request