Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Komorbida förhållanden vid psoriasis

Komorbiditeter, vilka rapporterats som redan existerande tillstånd hos minst 5% av patienterna från kliniska prövningar av psoriasis, tillhandahålls nedan.

Comorbid Conditions in UNCOVER-1, -2, and -3 Plaque Psoriasis Clinical Trials

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

  • cerebro-cardiovascular

  • respiratory

  • hepatic

  • renal

  • gastrointestinal

  • endocrine

  • hematologic

  • neurologic, or

  • neuropsychiatric

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 or serious infection were also excluded.1,2

Within the ixekizumab psoriasis phase 3 clinical development program, comorbidities (reported as preexisting conditions) that were reported in at least 5% of patients at baseline from UNCOVER-1, -2, and -3 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 moderate-to-severe plaque psoriasis in patients with or without specific comorbidities.2

Please refer to the Taltz summary of product characteristics for information regarding adverse drug reactions under treatment with ixekizumab.3

Table 1. Most Common Comorbid Conditions Reported at Baseline in UNCOVER-1, -2, and-3 Clinical Trials2

Comorbid Condition (MedDRA Preferred Term) ab

UNCOVER-1
ITT Population
N=1296
n (%)

UNCOVER-2
ITT Population
N=1224
n (%)

UNCOVER-3
ITT Population
N=1346
n (%)

Hypertension

412 (31.8)

312 (25.5)

414 (30.8)

Psoriatic arthropathy

343 (26.5)

288 (23.5)

277 (20.6)

Dyslipidaemia

222 (17.1)

154 (12.6)

163 (12.1)

Type 2 diabetes mellitus

119 (9.2)

102 (8.3)

128 (9.5)

Obesity

114 (8.8)

89 (7.3)

88 (6.5)

Depression

108 (8.3)

113 (9.2)

93 (6.9)

Seasonal allergy

104 (8.0)

74 (6.0)

86 (6.4)

Gastroesophageal reflux disease

97 (7.5)

79 (6.5)

103 (7.7)

Hypercholesterolaemia

96 (7.4)

64 (5.2)

58 (4.3)

Hyperlipidaemia

94 (7.3)

50 (4.1)

71 (5.3)

Hypothyroidism

73 (5.6)

49 (4.0)

63 (4.7)

Asthma

72 (5.6)

57 (4.7)

56 (4.2)

Anxiety

69 (5.3)

53 (4.3)

41 (3.0)

Osteoarthritis

65 (5.0)

60 (4.9)

48 (3.6)

Back pain

56 (4.3)

69 (5.6)

47 (3.5)

Arthralgia

46 (3.5)

55 (4.5)

68 (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 8.0% of patients from UNCOVER-1, 8.9% of patients from UNCOVER-2, and 5.6% of patients from UNCOVER-3 at baseline.

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

b Consists of patients across all treatment arms combined.

Therapeutic Indication

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.3

References

1. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

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

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

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 14


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