Taltz® (ixekizumab): Återinsättning av behandling för psoriasisartrit

Detailed Information

• Ixekizumab prescribing information does not include specific recommendations for reinitiating the dose when restarting ixekizumab following prior discontinuation or prolonged interruption of treatment.

The below mentioned dosing schedule IXE Q2W is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.¹

• SPIRIT-P3 consisted of an open-label period consisting of treatment with ixekizumab 80 mg Q2W followed by a randomized double-blind withdrawal period. This trial was conducted in patients naïve to bDMARDs.²

  • The 2 arms of the double-blind withdrawal period of SPIRIT-P3 were 

    • ixekizumab 80 mg given as 1 SC injection Q2W, and

    • placebo given as 1 SC injection Q2W.³

  • The primary outcome of SPIRIT-P3 is the time to relapse, defined as no longer meeting MDA.²

  • One of the secondary outcomes of SPIRIT-P3 is the time to regain MDA following relapse.²

  • All randomized patients who no longer meet MDA at any visit after entering the double-blind withdrawal period receive ixekizumab 80 mg Q2W for the remainder of the study period.³ The patients do not receive another 160-mg loading dose upon restarting ixekizumab therapy.

References

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

2. A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov website. https://www.clinicaltrials.gov/ct2/show/NCT02584855?term=SPIRIT-P3&rank=1. Updated November 6, 2018. Accessed March 13, 2019.

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

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

MDA = minimal disease activity

Q2W = every 2 weeks

SC = subcutaneous