Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Användning på patienter med psoriasis och psoriasisartrit som har histoplasmos

Det har inte utvärderats hur effektivt och säkert det är att använda ixekizumab på patienter med anamnes eller aktuell diagnos på histoplasmos.

Exclusion Criteria

Patients were excluded from the phase 3 UNCOVER clinical trials (for moderate-to-severe PsO) and the SPIRIT clinical trials (for active PsA) 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. 1-4

No patients in the phase 3 UNCOVER or SPIRIT trials reported a preexisting condition of histoplasmosis.5

Treatment-Emergent Adverse Events

Psoriasis

Using pooled data across 11 phase 1, phase 2, and phase 3 clinical trials in which patients with moderate-to-severe PsO received multiple, different dosing regimens of ixekizumab, data on TEAEs were collected from a total of 5730 patients, accounting for 13,479 PYs of exposure.5  

As of February 22, 2017, no patients who received ixekizumab in any of the treatment periods had reported the MedDRA-preferred term of “histoplasmosis.”5

Psoriatic Arthritis

In pooled data across 3 clinical trials conducted in patients with PsA, data on TEAEs were collected from a total of 1118 patients treated with ixekizumab, accounting for 1340.4 PYs of exposure.5

As of February 22, 2017, no patients had reported the MedDRA preferred term of "histoplasmosis."5

Infections

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).6

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.6

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.6

References

1. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. http://dx.doi.org/10.1016/S0140-6736(15)60125-8

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 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

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

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

Glossary

MedDRA = Medical Dictionary for Regulatory Activities

PsO = psoriasis

PY = patient-years

TEAE = treatment-emergent adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M04 01


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