Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Kan Taltz® (ixekizumab) användas hos patienter med herpes zoster?

Detta svar ger relevant information om användning av ixekizumab hos patienter med herpes zoster.

Exclusion Criteria Related to Herpes Zoster in the Ixekizumab Clinical Trials

In 3 phase 3 trials for psoriasis (UNCOVER-1, -2, and -3), 3 phase 3 trials for PsA (SPIRIT-P1, -P2, and –P3), and 3 phase 3 clinical trials for axSpA, including AS/r-axSpA and nr-axSpA (COAST-V, COAST-W, and COAST-X), patients were excluded if they

  • currently have or had a herpes zoster or any other clinically apparent varicella-zoster virus infection within 12 weeks of baseline, or

  • had any other active or recent infection within 4 weeks of baseline that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.1-6

Patients With Comorbid Herpes Zoster

Comorbid Herpes Zoster in the Psoriasis Clinical Trials

An analysis of the efficacy and safety of ixekizumab with moderate-to-severe PsO and comorbid herpes zoster has not been conducted. In the 3 phase 3 ixekizumab clinical trials in patients with PsO, 17 patients (0.7%) treated with ixekizumab had a historical illness of herpes zoster.6

Comorbid Herpes Zoster in the Psoriatic Arthritis Clinical Trials

An analysis of the efficacy and safety of ixekizumab with moderate-to-severe active PsA and comorbid herpes zoster has not been conducted. In the 2 phase 3 ixekizumab clinical trials in patients with PsA, SPIRIT-P1, and -P2, no patients treated with ixekizumab had a historical illness of herpes zoster. In the phase 3 clinical trial SPIRIT-P3, 3 (0.8%) patients had a historical illness of herpes zoster.6

Comorbid Herpes Zoster in the Axial Spondyloarthritis Clinical Trials

An analysis of the efficacy and safety of ixekizumab with axSpA and comorbid herpes zoster has not been conducted. In the 3 phase 3 ixekizumab clinical trials in patients with axSpA (including AS/r-axSpA and nr-axSpA), 7 patients (1.2%) treated with ixekizumab had a historical illness of herpes zoster.6

Ixekizumab Label Information Related to Infections

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).7

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.7

Ixekizumab should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If an infection develops, monitor carefully and discontinue ixekizumab if the patient is not responding to standard therapy or the infection becomes serious. Ixekizumab should not be resumed until the infection resolves.7

This information is for reference only and is not a treatment recommendation. Decisions regarding the use of ixekizumab in patients with herpes zoster should be made at the discretion of the prescribing physician using his or her best clinical judgment.

References

1. 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

2. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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

3. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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

4. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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

5. Deodhar A, van der Heijde D, Gensler LS, et al. 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

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

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

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

Datum fӧr senaste ӧversyn 2020 M07 17


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