Taltz® (Ixekizumab)

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Ixekizumab: Seguridad general en pacientes con artritis psoriásica

La información de seguridad de la información de prescripción de ixekizumab y los ensayos clínicos están disponibles en esta carta-respuesta.

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General Safety Information in Psoriatic Arthritis Clinical Trials

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

AEs of Special Interestd

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)b

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 = 80 mg ixekizumab 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.

dReported as adverse events according to the high-level term in the Medical Dictionary for Regulatory Activities.

Integrated Safety Data Across 4 Psoriatic Arthritis Clinical Trials

The integrated safety dataset includes data through March 2019 from 4 controlled and uncontrolled 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 2228.6 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 Set5

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2228.6)b

Patients with ≥1 TEAE

1128 (80.5) [50.6]c

Patients with ≥1 SAE

133 (9.5) [6.0]

Deaths

6 (0.4) [0.3]

Discontinuation due to AE

114 (8.1) [5.1]

Abbreviations: AE = adverse event; IR = incidence rate; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
Notes: Patients may be counted in more than 1 category. 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.

aIR per 100 PYs.

bData through March 21, 2019.

cThe most commonly reported TEAEs (IR per 100 PYs) were nasopharyngitis (9.1), upper respiratory tract infection (unspecified: 8.3), and injection site reaction (7.0).

Adverse Events of Special Interest in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set5

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2228.6)b

Infections

759 (54.2) [34.1]

Serious infections

28 (2.0) [1.3]

Oral candidiasis

16 (1.1) [0.7]

Injection site reactions

259 (18.5) [11.6]

Inflammatory bowel disease (adjudicated)

3 (0.2) [0.1]c

MACE (Adjudicated)

12 (0.9) [0.5]

Malignancies

15 (1.1) [0.7]

Depression

37 (2.6) [1.7]d

Abbreviations: IR = incidence rate; IXE = ixekizumab; MACE = major adverse cerebrocardiovascular events; PY = patient year.

aThe IR per 100 PYs considered exposure time as the entire time on ixekizumab.

bData through March 21 2019.

cCrohn's disease, n=2; ulcerative colitis, n=1.

dThe rate of suicide ideation or behavior was <.01. There were no completed suicides in the psoriatic arthritis clinical studies.

References

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

2Mease 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

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 antirheumatic drugs with active psoriatic arthritis [abstract]. Arthritis Rheumatol. 2015;67(suppl10). 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. 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

5Genovese MC, Mysler E, Tomita T, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials. Rheumatology (Oxford). Published online May 25, 2020. https://doi.org/10.1093/rheumatology/keaa189

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: 2020 M05 22


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