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 patienter med hepatit C använda Taltz® (ixekizumab)?

Användning av ixekizumab hos patienter med hepatit C har inte studerats.

Ixekizumab Label Information Related to Infections

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.1

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.1

Information from Clinical Trials

Clinical Trial Exclusion Criteria

The use of ixekizumab in patients with HCV has not been studied.

In the pivotal phase 3 clinical trials for PsO, PsA, and axSpA (including AS/r-axSpA and nr-axSpA), patients who had evidence of or tested positive for HCV were excluded.2-7

A positive test for HCV was defined as

  • positive for hepatitis C antibody, and

  • positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).2-7

Treatment-Emergent Adverse Events

Psoriasis

Among all ixekizumab exposures in PsO (N=6645; 17,902 PYs) as of March 2020, there was 1 (0.0%) reported case of hepatitis C and 1 (0.0%) reported case of acute hepatitis C.8

Psoriatic Arthritis

Among all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, -P3, and SPIRIT-H2H; N=1401; 2247.7 PYs) as of March 2020, there were no cases of hepatitis C reported.8

Axial Spondyloarthritis

Among all ixekizumab exposures in axSpA trials (including AS/r-axSpA and nr-axSpA; N=932; 1849 PYs), as of March 2020, there were no cases of hepatitis C reported.8

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. 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 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

4. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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

5. 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

6. 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

7. 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

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

Glossary

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

axSpA = axial spondyloarthritis

HCV = hepatitis C virus

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

Datum fӧr senaste ӧversyn 2020 M08 05


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss