Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Behandlingsrelaterat eksem och användning på patienter med eksem från psoriasis och psoriasisartrit i kliniska prövningar

Information om behandlingsrelaterat eksem, samtidig användning av eksemläkemedel och användning på patienter med anamnes av eksem finns nedan.

Detailed Information

The safety and efficacy of ixekizumab in patients with eczema have not been evaluated by Lilly.

Eczema were uncommonly reported adverse drug reactions (ADRs) according to the Taltz summary of product characteristics.1

Preexisting Eczema

Eczema was not a specific criterion for exclusion from ixekizumab clinical trials conducted in patients with moderate-to-severe plaque psoriasis or PsA. In the psoriasis safety population from the 3 pivotal UNCOVER clinical trials, MedDRA preferred term "eczema" was reported as a

  • preexisting condition in 1 patient (0.0%), and

  • historical illness in 1 patient (0.0%).2

No patients reported a preexisting condition or historical illness of eczema in the 2 pivotal SPIRIT PsA trials.

Treatment-Emergent Eczema

Incidence of treatment-emergent eczema in the psoriasis and PsA clinical trials as of 22-Feb-2017 data cutoff is provided in Table 1.

Of the psoriasis clinical trial eczema AEs,

  • 1 was considered a SAE, and

  • 2 led to discontinuation.2

There were no eczema SAEs or eczema AEs leading to discontinuation in the PsA clinical trials as of the data cutoff.2

Treatment-emergent adverse events are defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical study. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a TEAE of the type listed. Adverse events reported during the studies were not necessarily caused by the therapy and the frequencies do not reflect investigator assessment of causality.

Table 1. Incidence of Eczema TEAEs in Psoriasis and Psoriatic Arthritis Clinical Trials2

MedDRA Preferred Term

All Psoriasis Ixekizumab Exposures
N=5730
n (%)

All Psoriatic Arthritis Ixekizumab Exposures
N=1118
n (%)

Eczema

151 (2.6) 

11 (1.0) 

Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment-emergent adverse event.

Concomitant Medications for Eczema Reported in Psoriasis Clinical Trials

Across 7 ixekizumab registration clinical trials in psoriasis (including phase 1, phase 2, and phase 3 studies), TEAEs were collected from a total of 4209 patients exposed to ixekizumab as of 15-Apr-2015. Eczema was reported as a TEAE in 92 patients in this data set.3 Of the 92 patients who reported treatment-emergent eczema, 58 (63%) were reported to have received ≥1 concomitant medication.2 These concomitant medications received in patients who reported eczema are summarized in Table 2below.

Table 2.  Concomitant Medications Provided for the Indication of Treatment-Emergent Eczema across 7 Psoriasis Clinical Trials2

Concomitant Medications for Indication of Eczema ab

N=58c
n (%)

Topical corticosteroid, potent

26 (45)

Topical corticosteroid, moderately potent

8 (14)

Topical corticosteroid, weak

7 (12)

Topical corticosteroid, potent, combination with antibiotic

4 (7)

Topical corticosteroid, very potent

4 (7)

Antihistamines for systemic use

4 (7)

Concomitant therapy was coded using WHO Drug Dictionary Version Jun13B2.

a Concomitant medications listed reflect those reported as eczema for indication in at least 4 patients. Values reflect percentages of all patients who reported a concomitant medication for eczema.

b Topical corticosteroids across potency classes were allowed during the open label treatment period in the UNCOVER studies for any indication for use.

c Patients reported to have received ≥1 concomitant medication for eczema indication.

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1

References

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

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

3. Strober B, Leonardi C, Papp KA, et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76(3):432-440.e17. http://dx.doi.org/10.1016/j.jaad.2016.09.026

Glossary

AE = adverse event

Lilly = Eli Lilly and Company

MedDRA = Medical Dictionary for Regulatory Activities

PsA = psoriatic arthritis

SAE = serious adverse event

TEAE = treatment-emergent adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M11 05


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