Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZ® (ixekizumab): Infections in the Pediatric Psoriasis Clinical Trial

Ixekizumab may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.

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en-US

Infection-Related Label Information

Ixekizumab may increase the risk of infection. Instruct patients treated with ixekizumab to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves.1

Evaluate patients for TB infection prior to initiating treatment with ixekizumab. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiating ixekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ixekizumab should be monitored closely for signs and symptoms of active TB during and after treatment.1

In clinical trials of adult patients with plaque psoriasis, the ixekizumab group had a higher rate of infections than the placebo group (27% vs 23%).

Infections that occurred more frequently in the ixekizumab group than in the placebo group were

  • upper respiratory tract infections
  • oral candidiasis
  • conjunctivitis, and
  • tinea infections.1

A similar increase in risk of infection was seen in the placebo-controlled trial in patients with pediatric psoriasis.

Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with ixekizumab Q4W is consistent with the safety profile in adult patients with plaque psoriasis with the exception of

  • conjunctivitis (adults, less than 1%; pediatrics, 2.6%)
  • influenza (adults, less than 1%; pediatrics, 1.7%), and
  • urticaria (adults, less than 1%; pediatrics, 1.7%).1

Treatment-Emergent Infections in IXORA-PEDS

A summary of treatment-emergent infections in IXORA-PEDS are listed in  .

During the double-blind treatment period

  • there were no severe or serious infection-related AEs
  • no patients discontinued study drug due to an infection-related AE, and
  • there were no opportunistic infections or candida infections.2,3

In the all ixekizumab exposure population as of the 48-week interim database lock

  • 1 patient (0.5%) reported a severe infection (pharyngitis)
  • 2 patients (1.0%) reported serious infections (1 each of otitis media acute and tonsillitis)
  • no patients discontinued study drug due to an infection-related AE
  • there were no opportunistic infections, and
  • 1 patient (0.5%) reported a TEAE of fungal infection, which was a mild oral candida infection of 5 days duration.2,3
IXORA-PEDS: Treatment-Emergent Infectionsa in the Double-Blind Treatment Period and Combined Treatment Periods Through the 48-Week Interim Database Lock2,3


12-Week Double-Blind Treatment Period

Combined Treatment Periods, All Ixekizumab Safety Populationb

 

Placebo
N=56
n (%)

Ixekizumab Q4W
N=115
n (%)

Total Ixekizumab
N=196
n (%)

Infections overall

14 (25.0)

37 (32.2)

129 (65.8)

Severe infections

0

0

1 (0.5)c

Opportunistic infections

0

0

0

Candida

0

0

1 (0.5)d

Nasopharyngitis

4 (7.1)

13 (11.3)

34 (17.3)

Upper respiratory tract infection

4 (7.1)

6 (5.2)

35 (17.9)

Pharyngitis

0

2 (1.7)

17 (8.7)

Conjunctivitis

0

3 (2.6)

15 (7.7)

Tonsillitis

2 (3.6)

1 (0.9)

15 (7.7)

Impetigo

0

1 (0.9)

13 (6.6)

Viral upper respiratory tract infection

0

2 (1.7)

11 (5.6)

Pharyngitis streptococcal

0

2 (1.7)

9 (4.6)

Viral infection

2 (3.6)

2 (1.7)

8 (4.1)

Gastroenteritis

0

0

8 (4.1)

Influenza

0

2 (1.7)

8 (4.1)

Folliculitis

0

1 (0.9)

7 (3.6)

Oral herpes

0

0

7 (3.6)

Pharyngotonsillitis

0

1 (0.9)

7 (3.6)

Urinary tract infection

0

0

7 (3.6)

Ear infection

1 (1.8)

1 (0.9)

6 (3.1)

Gastroenteritis viral

0

0

6 (3.1)

Otitis externa

0

2 (1.7)

6 (3.1)

Abbreviations: PY = patient-years; Q4W = every 4 weeks.

aOccurring in ≥3% of ixekizumab-treated patients or adverse event of special interest.

bAll patients exposed to ixekizumab in the induction, maintenance, and extension periods through the 48-week interim database lock (253.9 total PY of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.

cPharyngitis.

dMild oral candida infection.

Integrated Safety Across All Ixekizumab Psoriasis Clinical Trials

An integrated safety analysis was conducted from all ixekizumab psoriasis exposures (N=6091; PY=17,499.3) across 14 plaque psoriasis clinical trials, including IXORA-PEDS, as of March 2019. The proportion of patients with

  • any infection was 65.3% [IR=22.7/100 PYs of exposure]
  • serious infections was 3.7% [IR=1.3/100 PYs of exposure], and
  • oral candidiasis was 2.3% [IR=0.8/100 PYs of exposure].

The IR of infections did not increase with longer ixekizumab exposure.4

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

2Paller AS, Seyger MMB, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. 2020;183(2):231-241. https://doi.org/10.1111/bjd.19147

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Genovese MC, Kameda H, Rahman P, et al. Safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis and psoriatic arthritis: integrated analysis of 18 clinical trials. Poster presented at: American College of Rheumatology/ARP; November 8-13, 2019; Atlanta, GA.

Glossary

AE = adverse event

IR = incidence rate

PY = patient-years

Q4W = every 4 weeks

TB = tuberculosis

TEAE = treatment-emergent adverse event

Date of Last Review: May 21, 2020


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