Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Biverkningar hos patienter med måttlig till svår plackpsoriasis med tidigare biologisk behandling

Ingen övergripande skillnad i säkerhetsrisk observerades mellan patienter med eller utan tidigare exponering av biologiska läkemedel.

Previous Biologic Use in Psoriasis Clinical Trials

The efficacy and safety of ixekizumab was demonstrated regardless of previous treatment with a biologic.1

  • No overall difference in safety risk was observed between patients with and without previous exposure to biologics in ixekizumab psoriasis clinical trials (see Table 1).2

  • In ixekizumab phase 3 UNCOVER clinical trials, 26% of all patients had received prior biologic therapy for the treatment of psoriasis. Of these, 15% had received at least 1 anti-TNF alpha agent and 9% had received an anti-IL-12/IL-23.2

  • No significant treatment-by-previous biologic subgroup interactions were observed when the following TEAEs of special interest were analyzed: injection site reactions, infection-related TEAEs, or allergic reaction/hypersensitivity TEAEs (see Table 1).2

Table 1. Treatment-Emergent Adverse Event Incidence Based on Previous Biologic Subgroup from 12-Week Induction Dosing Period of 3 UNCOVER Clinical Trials2

Previous Biologic Usea

All TEAE Incidence

 

IXE Q2W (Label Approved Dose)

IXE Q4W

PBO

Yes

171/315 (54.3%)

177/311 (56.9%)

123/257 (47.9%)

No

510/852 (59.9%)

506/850 (59.5%)

247/534 (46.3%)

 

Injection Site Reactions Incidenceb

 

IXE Q2W (Label Approved Dose)

IXE Q4W

PBO

Yes

43/315 (13.7%)

36/311 (11.6%)

12/257 (4.7%)

No

153/852 (18.0%)

114/850 (13.4%)

14/534 (2.6%)

 

Infection-Related TEAE Incidencec

 

IXE Q2W (Label Approved Dose)

IXE Q4W

PBO

Yes

79/315 (25.1%)

85/311 (27.3%)

61/257 (23.7%)

No

236/852 (27.7%)

233/850 (27.4%)

120/534 (22.5%)

 

Allergic Reaction/Hypersensitivity TEAE Incidenced

 

IXE Q2W (Label Approved Dose)

IXE Q4W

PBO

Yes

11/315 (3.5%)

9/311 (2.9%)

5/257 (1.9%)

No

30/852 (3.5%)

37/850 (4.4%)

12/534 (2.2%)

Abbreviations: IXE = Ixekizumab; PBO = Placebo; Q2W = every 2 weeks; Q4W = every 4 weeks; TEAE = treatment-emergent adverse event.
Statistical Results: There were no statistically significant treatment-by-previous biologic treatment subgroup interactions for the analyses listed above.

Please refer to the Taltz summary of product characteristics for the full list of adverse reactions.

a In ixekizumab phase 3 UNCOVER clinical trials, 26% of all patients had received prior biologic therapy for the treatment of psoriasis. Of these, 15% had received at least 1 anti-TNF alpha agent, and 9% had received an anti-IL-12/IL-23.

b The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.

c The most frequent infections reported were nasopharyngitis, upper respiratory tract infections, and urinary tract infections.

d Most allergic reactions/hypersensitivity events were mild or moderate and did not lead to discontinuation. There were no confirmed cases of ixekizumab-related anaphylaxis events.

The dosing schedule IXEQ4W during the first 12 weeks of treatment (induction phase) is not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 1

Therapeutic Indication

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

Glossary

IL-17 = interleukin-17

IL-23 = interleukin-23

TEAE = treatment-emergent adverse event

TNF = tumor necrosis factor

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 2020 M01 10


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