Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® (ixekizumab): Concomitant Psoriasis Therapy

The safety of ixekizumab in combination with other immunomodulatory agents or phototherapy has not been evaluated. Information on topical steroid therapies permitted during clinical studies is available in this response.

Pharmacokinetic Analyses

In population pharmacokinetic analyses, drug clearance of ixekizumab was not affected by concomitant administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate.1

Concomitant Psoriasis Therapies in Psoriasis Clinical Trials

The information provided is for reference only and does not constitute a treatment recommendation. Please find information regarding pharmacokinetics and drug interactions in the Taltz summary of product characteristics.1

Allowed Medication per Study Protocol

Clinical trial participants were allowed to use as needed

  • shampoos that do not contain

    • >3% salicylic acid

    • coal tar, or

    • vitamin D3 analogues, and

  • topical moisturizers/emollients and other nonprescription topical products that do not contain

    • urea

    • >3% salicylic acid

    • alpha- or beta-hydroxyl acids

    • corticosteroids, or

    • vitamin D3 analogues, and

  • bath oils and oatmeal bath preparations.2

These topical therapies were not to be used within 12 hours prior to a study visit.2

After week 60 assessments were complete, participants could use, as needed, shampoos that contain >3% salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues.2

During the UNCOVER-1, -2, and -3 clinical trials, treatment with concomitant systemic psoriasis therapies was not permitted, and patients were excluded if they had received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks prior to baseline, or most topical psoriasis treatments within 2 weeks prior to baseline. Additional exclusion criteria included concurrent or recent use of any biologic agent within specified washout periods, and ever having received therapy with an IL-17 antagonist.2

In the pivotal plaque PsO clinical trials, all doses of concomitant medications were to be stable at baseline and to remain stable for the duration of the study, unless changes needed to be made for an AE or for appropriate medical management. The rationales for excluding certain medications were their potential effects on efficacy or safety parameters within the trials.2

Used Concomitant Psoriasis Therapies in Clinical Trials

Topical Therapies

Topical steroid therapies that were permitted during the study were class 6 (mild) or class 7 (least potent) agents limited to use on the face, axilla, and/or genitalia, as needed (see Table 1 and Table 2).2

Induction Period (weeks 0 to 12)

Table 1. Percentage of Patients with Concomitant Topical Product Usage During the 12-Week Induction Period of UNCOVER-1, -2, and -33

 

PBO
(n= 431)

IXE Q4W
(n= 432)

IXE Q2W
(n= 433)

PBO
(n= 168)

ETN
(n= 358)

IXE Q4W
(n= 347)

IXE Q2W
(n= 351)

PBO
(n= 193)

ETN
(n= 382)

IXE Q4W
(n= 386)

IXE Q2W
(n= 385)


UNCOVER-1

UNCOVER-1

UNCOVER-1

UNCOVER-2

UNCOVER-2

UNCOVER-2

UNCOVER-2

UNCOVER-3

UNCOVER-3

UNCOVER-3

UNCOVER-3

1 Topical Medicationa

7.9%

4.2%

3.9%

6.5%

2.5%

3.7%

4.0%

5.2%

3.1%

2.8%

3.4%

1 Topical Steroid

4.2%

1.9%

2.1%

4.2%

1.1%

2.6%

2.3%

2.6%

1.3%

0

0.8%

Weakb

1.9%

0.7%

1.2%

1.8%

0.6%

0.6%

0.9%

0.5%

0.8%

0

0.8%

Moderatec

1.6%

0.9%

0.7%

2.4%

0.3%

1.4%

0.9%

2.1%

0.3%

0

0

Potentd

0.9%

0

0.2%

0

0

0.3%

0.3%

0

0.3%

0

0.3%

Abbreviations: ETN = etanercept; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.

a Topical medication products include soft paraffin products, corticosteroids, emollients, and protectives.

b Weak steroid medications include hydrocortisone, prednisolone, hydrocortisone acetate, prednisolone acetate, hydrocortisone sodium phosphate, and hydrocortisone valerate.

c Moderate steroid medications include desonide, triamcinolone acetonide, alclometasone dipropionate, and hydrocortisone butyrate.

d Potent steroid medications include betamethasone, difluprednate, flucinolone acetonide, mometasone furoate, and prednicarbate.

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

Maintenance Period (weeks 12 to 60)

Table 2. Percentage of Patients with Concomitant Topical Product Usage During the Maintenance Periods (Weeks 12 to 60) of UNCOVER-1and -23 


PBO
(n=226)

IXE Q4W
(n=229)

IXE Q12W
(n=227)

PBO
(n=176)

IXE Q4W
(n=187)

IXE Q12W
(n=181)


UNCOVER-1

UNCOVER-1

UNCOVER-1

UNCOVER-2

UNCOVER-2

UNCOVER-2

1 Topical Medicationa

2.2%

6.6%

6.2%

3.4%

2.7%

5.0%

1 Topical Steroid

1.8%

4.4%

4.8%

2.8%

2.1%

3.3%

Weakb

0.4%

1.7%

2.6%

1.1%

0.5%

1.1%

Moderatec

0.9%

1.7%

1.3%

1.7%

1.1%

1.1%

Potentd

0

0.9%

0.9%

0

0.5%

0.6%

Abbreviations: IXE = ixekizumab; PBO = placebo; Q4W = every 4 weeks; Q12W = every 12 weeks.

a Topical medication products include soft paraffin products, corticosteroids, emollients, and protectives.

b Weak steroid medications include hydrocortisone, prednisolone, hydrocortisone acetate, and hydrocortisone valerate.

c Moderate steroid medications include desonide, triamcinolone acetonide, and hydrocortisone butyrate.

d Potent steroid medications include betamethasone diproprionate, betamethasone valerate, desoximetasone, flucinolone acetonide, fludroxycortide, and ulobetasol.

 The dosing schedule IXEQ12W 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

Systemic Therapies

In plaque psoriasis studies, the safety of ixekizumab in combination with other immunomodulatory agents or phototherapy has not been evaluated.1

References

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

2. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

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

Glossary

AE = adverse event

IgG = immunoglobulin G

IL-17A = interleukin-17A

PsO = psoriasis

Date of Last Review: April 06, 2020


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