Taltz® (Ixekizumab)

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Ixekizumab: Concomitant Medication Use in Psoriasis Clinical Trials

In the pivotal phase 3 trials in patients with psoriasis, 41.6% of patients reported using ≥1 concomitant medication through week 12.

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The information contained in this letter may not completely match the current local labeling for IXEKIZUMAB. Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.

Concomitant Medications Allowed in Pivotal Psoriasis Clinical Trials

In the 3 pivotal clinical trials (UNCOVER-1, -2, and -3) conducted in patients with moderate-to-severe plaque psoriasis, patients maintained their usual medication regimens for other concomitant diseases throughout the trials unless those medications were specifically excluded in the protocols.1

Patients who took concomitant medications were on stable doses at baseline and remained at a stable dose throughout the trials, unless changes were made for an AE, appropriate medical management, or as specified in the clinical trial protocol.1

Permitted and Excluded Concomitant Medications in Phase 3 Psoriasis Clinical Trials UNCOVER-1, -2, and -3 lists concomitant medications that were specifically permitted or excluded over the course of the UNCOVER phase 3 clinical trials in patients with moderate-to-severe plaque psoriasis.

Permitted and Excluded Concomitant Medications in Phase 3 Psoriasis Clinical Trials UNCOVER-1, -2, and -31

Permitted Concomitant Medications

Nonlive vaccines if they were seasonal vaccinations or emergency vaccinations such as tetanus or rabies

Weak topical steroids including those from the mild class, such as desonide, and the least potent class, such as hydrocortisonea

Nonmedicated shampoos that do not contain corticosteroids, coal tar, or vitamin D3 analoguesb

Emollients that do not contain α- or β-hydroxyl acids

Excluded Concomitant Medications

Ultraviolet A light therapy

Ultraviolet B light therapy

Cyclosporine

Corticosteroids

Methotrexate

Oral retinoids

Mycophenolate mofetil

aThe designated topical steroids were permitted for use to the face, axilla, and/or genitalia. More potent topical steroids were permitted, as needed, after assessments were completed at week 12 in UNCOVER-3 and at week 60 in UNCOVER-1 and -2.

bCorticosteroids, coal tar, or vitamin D3 analogues in shampoos were permitted after assessments were completed at week 12 in UNCOVER-3 and at week 60 in UNCOVER-1 and -2.

Concomitant Medication Use in Psoriasis Clinical Trials

Across the 3 pivotal phase 3 clinical trials (UNCOVER-1, -2, and -3) conducted in patients with moderate-to-severe plaque psoriasis, 41.6% of patients reported taking at least 1 concomitant medication through week 12 of treatment.2 Most Common Concomitant Medications Reported Through Week 12 in the Phase 3 Psoriasis Clinical Trials UNCOVER-1, -2, and -3 lists concomitant medications reported in at least 1.0% of trial participants.

Most Common Concomitant Medications Reported Through Week 12 in the Phase 3 Psoriasis Clinical Trials UNCOVER-1, -2, and -32

Concomitant Medications Reporteda

IXE and PBO Groups (N=3119)

Ibuprofen

167 (5.4)

Paracetamol (acetaminophen)

140 (4.5)

Amoxicillin

46 (1.5)

Cough and cold preparations

39 (1.3)

Influenza vaccine

36 (1.2)

Azithromycin

33 (1.1)

Ciprofloxacin

30 (1.0)

Acetylsalicylic acid (aspirin)

30 (1.0)

Abbreviations: IXE = ixekizumab; PBO = placebo.

aData presented as n (%).

References

1Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. 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

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

Glossary

AE = adverse event

Fecha de la última revisión: 2020 M03 13


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