Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Infektioner i den kliniska prövningen för pediatrisk psoriasis

Behandlingrelaterade biverkningar av infektioner med ixekizumab-behandling i den kliniska prövningen för psoriasis hos barn tillhandahålls.

Ixekizumab Infections-Related Label Information

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1

Ixekizumab must not be given to patients with active tuberculosis (TB). Consider anti-TB therapy prior to initiation of ixekizumab in patients with latent TB.1

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.1

Ixekizumab should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If an infection develops, monitor carefully and discontinue ixekizumab if the patient is not responding to standard therapy or the infection becomes serious. Ixekizumab should not be resumed until the infection resolves.1

The safety profile observed in children with plaque psoriasis treated with ixekizumab every 4 weeks is consistent with the safety profile in adult patients with plaque psoriasis with the exception of the frequencies of conjunctivitis, influenza, and urticaria which were common.1

Further information on this topic is available in section 4.8 of the Taltz Summary of Product Characteristics.1

Treatment-Emergent Infections in IXORA-PEDS

A summary of treatment-emergent infections in IXORA-PEDS are listed in Table 1.

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

Table 1. 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.

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

b All 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.

c Pharyngitis.

d Mild 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

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

2. Paller AS, Seyger MMA, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. Published online April 21, 2020. https://doi.org/10.1111/bjd.19147

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

4. Genovese 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

Datum fӧr senaste ӧversyn 2020 M05 21


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