Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Taltz® ▼ (ixekizumab): Komorbiditeter i kliniska fas 3-prövningar med psoriasisartrit

Komorbiditeter som rapporterats hos minst 5% av patienterna från SPIRIT-P1 och SPIRIT-P2 tillhandahålls nedan.

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

Psoriatic arthritis

The safety and efficacy of ixekizumab were 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 in these studies had a diagnosis of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 5.33 years. Randomised patients also 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. Over 58.9% and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively. For both studies, the primary endpoint was American College of Rheumatology (ACR) 20 response at Week 24.5

Therapeutic Indication

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.5

References

1. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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

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.

Datum fӧr senaste ӧversyn 2018 M09 28


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss