Skip To Main Content
Lilly
Menu closed
Lilly
  • Account Login / Register
  • Medical Home
    • Medical Information
  • Medical Education
  • Science
Ask Lilly

We're here to help.

Chat
Chat with us Chat with us
Question Contact Us
Expand contact lilly
Lilly

You are now leaving the LillyMedical.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to LillyMedical.com.

  1. Medical Information Right
  2. Immunology Right
  3. Taltz (ixekizumab) injection Right
  4. Can Taltz® (ixekizumab) be used in patients with histoplasmosis?
Search Taltz (type in keywords)
Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Loading icon

Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

Can Taltz® (ixekizumab) be used in patients with histoplasmosis?

The safety and efficacy of ixekizumab in patients with a historical or current diagnosis of hisotoplasmosis have not been evaluated.

US_cFAQ_IXE432_HISTOPLASMOSIS_PsO_PsA_axSpA
US_cFAQ_IXE432_HISTOPLASMOSIS_PsO_PsA_axSpA
en-US

Exclusion Criteria

Eli Lilly and Company has not been studied the use of ixekizumab in patients with histoplasmosis. Patients were excluded from the pivotal phase 3 UNCOVER-1, -2, and -3 clinical trials in moderate-to-severe psoriasis, the SPIRIT-P1 and SPIRIT-P2 clinical trials for active psoriatic arthritis, and the COAST-V, COAST-W, and COAST-X trials in axial spondyloarthritis (axSpA) if they

  • have or had an opportunistic infection characteristic of an immunocompromised host or that occurs with increased incidence in an immunocompromised host
  • have a known immunodeficiency, or
  • have a recent or serious infection requiring hospitalization or antibiotic treatment.1-6

No patients in the phase 3 UNCOVER, SPIRIT, or COAST trials reported a preexisting condition of histoplasmosis.7

Treatment-Emergent Adverse Events

Psoriasis

Using pooled data across 17 clinical trials in adult patients with moderate-to-severe plaque psoriasis, data on treatment-emergent adverse events (TEAEs) were collected from a total of 6892 patients, accounting for 18,025.7 patient-years of exposure.7  

As of March 2021, the Medical Dictionary for Regulatory Activities (MedDRA)-preferred term of histoplasmosis was not reported in any patients.7

Psoriatic Arthritis

In pooled data across 4 clinical trials conducted in patients with psoriatic arthritis, data on TEAEs were collected from a total of 1401 patients treated with ixekizumab, accounting for 2247.7 PYs of exposure.7

As of March 2021, the MedDRA-preferred term of histoplasmosis was not reported in any patients.7

Axial Spondyloarthritis

In pooled data across 4 clinical trials conducted in patients with axSpA, including ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) and nonradiographic axSpA (nr-axSpA), data on TEAEs were collected from a total of 932 patients treated with ixekizumab, accounting for 2096.2 PYs of exposure.7

As of March 2021, the MedDRA-preferred term of histoplasmosis was not reported in any patients.7

Infections

The folowing adverse events occurred more frequently in the ixekizumab treatment than in the placebo group: 

  • upper respiratory tract infection
  • oral candidiasis
  • conjunctivitis, and
  • tinea infections.8

In clinical trials in patients with PsO, infections were reported by

  • 27% of patients in the ixekizumab group, and
  • 23% of patients in the placebo group.8

A similar increase in risk of infection was seen in placebo-controlled trials in patients with psoriatic arthritis and axial spondyloarthritis.8  

Patients treated with ixekizumab should seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves. 8

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

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

2Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

3Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

4van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9

5Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753

6Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.

Date of Last Review: April 06, 2022

Are you satisfied with this content?

Can't find what you're looking for? Contact us for answers to your medical questions.

  • Copyright
  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap

    This site is intended for US Healthcare Professionals only.

    4.0.17 02/2023 | GLOOTH00001 04/2015 | © Lilly USA, LLC 2023. All rights reserved.

    Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

    facebook twitter linkedin
    visit www.phactmi.org
    Lilly