Taltz ® (ixekizumab) injection

80 mg/mL

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

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


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