Taltz® (Ixekizumab)

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What comorbid conditions were reported in the ixekizumab trials in psoriasis?

Hypertension, psoriatic arthropathy, and dyslipidemia were the 3 most frequently reported comorbidities in the pivotal UNCOVER-1, -2, and -3 ixekizumab clinical trials in patients with moderate-to-severe plaque psoriasis.

MX_cFAQ_IXE208_COMORBID_CONDITIONS_PSORIASIS
MX_cFAQ_IXE208_COMORBID_CONDITIONS_PSORIASIS
es-MX

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

This medical response may not completely match the information in the current local labeling for IXEKIZUMAB. Please see local labeling for approved label information.

In the pivotal ixekizumab psoriasis 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

  • cerebrocardiovascular
  • 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

Most Common Comorbid Conditions Reported at Baseline in UNCOVER-1, -2, and -3 Clinical Trials lists comorbidities (reported as preexisting conditions) that were reported in at least 5% of patients at baseline from the ixekizumab UNCOVER-1, -2, and -3 phase 3 trials in patients with moderate-to-severe psoriasis.

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

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, although 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.

aReported as preexisting conditions at baseline of the clinical trials.

bConsists of patients across all treatment arms combined.

References

1Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. 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

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

Fecha de la última revisión: 2021 M07 12


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