Taltz® (Ixekizumab)

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Ixekizumab: General Safety Information in Psoriatic Arthritis Clinical Trials

Safety information from the ixekizumab prescribing information and clinical trials are available in this response.

MX_cFAQ_IXE027_GENERAL_SAFETY_PsA
MX_cFAQ_IXE027_GENERAL_SAFETY_PsA
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General Safety Information in Psoriatic Arthritis 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.

Hypersensitivity Reactions: Ixekizumab is contraindicated in patients with a known serious hypersensitivity reaction to ixekizumab or to any of the excipients. Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, and urticaria, have been reported. If a serious hypersensitivity reaction occurs, administration of ixekizumab should be discontinued immediately and appropriate therapy initiated.1

Infections: Ixekizumab treatment is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections. Ixekizumab should be used with caution in patients with clinically important chronic or active infection. If such an infection develops, monitor carefully and discontinue ixekizumab if the patient is not responding to standard therapy or the infection becomes serious. Do not resume ixekizumab until the infection resolves. Ixekizumab should not be given to patients with active TB. Consider anti-TB therapy prior to initiation of ixekizumab in patients with latent TB.1

Inflammatory Bowel Disease: Cases of new or exacerbations of CD and UC have been reported. Caution should be exercised when prescribing ixekizumab to patients with IBD, including CD and UC, and patients should be monitored closely.1

Immunizations: Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines.1

Treatment-Emergent Adverse Events Reported in the Double-Blind Treatment Period of SPIRIT-P1 and -P2

SPIRIT-P1

SPIRIT-P1 Safety Overview During Double-Blind Treatment Period (Ixekizumab and Placebo Groups)2,3

 

PBO
N=106
n (%)

IXE Q4W
N=107
n (%)

IXE Q2W
N=102
n (%)

TEAE

50 (47.2)

71 (66.4)a

67 (65.7)a

Mild

27 (25.5)

43 (40.2)a

41 (40.2)a

Moderate

21 (19.8)

24 (22.4)

21 (20.6)

Severe

2 (1.9)

4 (3.7)

5 (4.9)

SAEs

2 (1.9)b

6 (5.6)c

3 (2.9)d

DC due to AE

2 (1.9)

2 (1.9)

4 (3.9)

AEs of Special Intereste

36 (34.0)

52 (48.6)f

56 (54.9)g

Infection

27 (25.5)

30 (28.0)

24 (23.5)

Any candida Infection

0

1 (0.9)

1 (1.0)

Active or reactivated tuberculosis

0

0

0

Injection site reactions

5 (4.7)

26 (24.3)a

27 (26.5)a

Hepatic event

7 (6.6)

5 (4.7)

9 (8.8)

Allergic reaction/hypersensitivity

3 (2.8)

2 (1.9)

5 (4.9)

Cytopenia (all types)

6 (5.7)

1 (0.9)

4 (3.9)

Neutropenia

0

0

1 (1.0)

Depression

0

2 (1.9)

1 (1.0)

Cerebrocardiovascular event

0

0

0

Malignancy

1 (0.9)

0

0

Abbreviations: AE = adverse event; DC = discontinuation; IXE Q2W = 80 mg ixekizumab every 2 weeks following a 160 mg starting dose; IXE Q4W = 80 mg ixekizumab every 4 weeks following a 160 mg starting dose; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo every 2 weeks; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

ap≤.001 vs PBO (for ixekizumab groups).

bThe 2 SAEs were Bartholin's cyst and hepatic enzyme increased.

cSix patients reported a total of 8 SAEs (more than 1 event occurred in a single patient): gastroenteritis, pancreatitis acute, post-traumatic headache, uterine polyp, cholelithiasis, fall, fibula fracture, and lumbar spinal stenosis.

dThree patients reported a total of 5 SAEs (more than 1 event occurred in a single patient): herpes zoster, esophageal candidiasis, impaired gastric emptying, cervical myelopathy, and acquired phimosis.

eReported as adverse events and coded using MedDRA v17.1. Groups of adverse events of special interest are shown.

fp<.05 vs PBO.

gp≤.01 vs PBO.

SPIRIT-P2

SPIRIT-P2 Safety Overview During 24-Week Double-Blind Treatment Period4

 

PBO
(N=118)
n (%)

IXE Q4W
(N=107)
n (%)

IXE Q2W
(N=102)
n (%)

TEAE

76 (64)

83 (68) 

90 (73)

Mild

32 (27)

48 (39)

43 (35)

Moderate

42 (36)

31 (25)

38 (31)

Severe

2 (2)

4 (3)

9 (7)

SAE

4 (3)a

3 (2)b

8 (7)c

Adverse Events of special interest 

Infection

35 (30.0)

47 (39)

47 (38)

Any Candida infection

0

2 (2)

6 (5)

Active or reactivated tuberculosis

0

0

0

Injection site reactions

5 (4)

14 (11)

29 (24)

Hepatic event

2 (2)

2 (2)

5 (4)

Allergic reaction/hypersensitivity

1 (1)

8 (7)

9 (7)

Cytopenia (all types)

6 (5.7)

1 (0.9)

4 (3.9)

Neutropenia

0

0

1 (1.0)

Depression

3 (3)

2 (2)

2 (2)

Cerebrocardiovascular event

2 (2)

0

0

Malignancy

1 (0.9)

0

0

DC due to AE

6 (5)

5 (4)

8 (7)

Abbreviations: AE = adverse event; DC = discontinuation; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = 80 mg ixekizumab every 4 weeks; PBO = placebo every 2 weeks; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aFour patients reported a total of 5 SAEs (more than 1 event occurred in a single patient): abdominal pain, femoral neck fracture, tendon rupture, adnexa uteri cyst, and peripheral arterial occlusive disease.

bThree patients reported a total of 4 SAEs (more than 1 event occurred in a single patient): vertigo, myofascial pain syndrome, prostate cancer, and cervicobrachial syndrome.

cEight patients reported a total of 10 SAEs (more than 1 event occurred in a single patient): abscess jaw, anal abscess, perirectal abscess, iron deficiency anemia, vertigo, anal fistula, foot fracture, diabetes mellitus, spontaneous abortion, and uterine prolapse.

Integrated Safety Data Across 4 Psoriatic Arthritis Clinical Trials

The integrated safety dataset includes data through March 19, 2020 from 4 clinical trials in patients with active PsA, including pivotal phase 3 trials SPIRIT-P1 and -P2, phase 3 trial SPIRIT-P3, and phase 4 trial SPIRIT-H2H (N=1401, accounting for 2247.7 PYs of total ixekizumab exposure).5

Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 20205

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2247.7)

Patients with ≥1 TEAEb

1131 (80.7) [50.3]c

Mild

461 (32.9) [20.5]

Moderate

556 (39.7) [24.7]

Severe

114 (8.1) [5.1]

Patients with ≥1 SAE

134 (9.6) [6.0]

Deaths

6 (0.4) [0.3]

Discontinuation due to AE

115 (8.2) [5.1]

Abbreviations: AE = adverse event; IR = incidence rate; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
Note: Patients with multiple occurrences of the same event are categorized by the highest severity. Deaths are included among SAEs and among discontinuations due to AEs.

aIncidence rate per 100 PYs.

bPatients with multiple occurrences of the same event were counted under the highest severity.

cThe most commonly reported TEAEs (IR per 100 PYs) were nasopharyngitis (9.0), upper respiratory tract infection (8.3), and injection site reactions (6.9).

Adverse Events of Special Interest in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 20205

Event, n (%) [IR]

Pooled IXE
(N=1401; PY=2247.7)

Infections

759 (54.2) [33.8]

Serious infections

28 (2.0) [1.2]

Candida infections

45 (3.2) [2.0]

Potential opportunistic infections

40 (2.9) [1.8]

Injection site reactionsa

260 (18.6) [11.6]

Hepatic reactionsb

112 (8.0) [5.0]

Allergic/hypersensitivity reactions 

102 (7.3) [4.5]

Cytopeniasc

56 (4.0) [2.5]

Inflammatory bowel disease (adjudicated)d

3 (0.2) [0.1]e

MACE (adjudicated)

12 (0.9) [0.5]

Malignancies

15 (1.1) [0.7]

Depression

37 (2.6) [1.6]

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; IXE = ixekizumab; MACE = major adverse cerebrocardiovascular events; MedDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; SMQ = Standardized MedDRA Query.

aBroad according to SMQ classification.

bThe most common hepatic reactions were alanine aminotransferase increased (n=37), aspartate aminotransferase increased (n=28), gamma-glutamyltransferase increased (n=21), and hepatic steatosis (n=21).

cBroad according to SMQ classification. The most common cytopenias were neutropenia (n=29), leukopenia (n=18), and neutrophil count decreased (n=9).

dThe data represent cases classified as “definite” and “probable” per external adjudication.

eThree patients had events of IBD confirmed by adjudication. One patient had more than 1 event. Crohn's disease (n=2); ulcerative colitis (n=1).

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Mease 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

3Mease PJ, van der Heijde D, Ritchlin CT, et al. A randomized, double-blind, active- and placebo-controlled phase 3 study of efficacy and safety of ixekizumab, adalimumab, and placebo therapy in patients naïve to biologic disease modifying anti-rheumatic drugs with active psoriatic arthritis. Arthritis Rheumatol. 2015;67(suppl 10):997. 2015 ACR/ARHP Annual Meeting abstract 997. https://acrabstracts.org/abstract/a-randomized-double-blind-active-and-placebo-controlled-phase-3-study-of-efficacy-and-safety-of-ixekizumab-adalimumab-and-placebo-therapy-in-patients-naive-to-biologic-disease-modifying-anti/.

4Nash 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

5Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

Glossary

AE = adverse event

CD = Crohn's disease

IBD = inflammatory bowel disease

PsA = psoriatic arthritis

PY = patient-years

SAE = serious adverse event

TB = tuberculosis

TEAE = treatment-emergent adverse event

UC = ulcerative colitis

Fecha de la última revisión: 2021 M04 27


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