Dactylitis
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Taltz showed improvement in patients with preexisting dactylitis2,3,10
In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=28, mean baseline=31.5; placebo n=14, mean baseline=37.3), 75% of Taltz patients had complete resolution of dactylitis at week 24 vs 21% for placebo.
The data presented were from post hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.
Mean baseline LDI-B was 73.0 for Taltz and 62.7 for placebo.
Inadequate responders (<20% in tender and in swollen join counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
LDI-B=Leads Dactylitis Index-Basic.
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ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Post hoc analysis: resolution of dactylitis (LDI-B=0) through week 1083,11
Double-blind and open-label extension periods, ITT population, mNRI and observed
Primary endpoint=ACR20 response at week 24.
mNRI, a preferred method for analyzing long term efficacy, imputes missing data due to study drug (e.g., inadequate response, adverse event, or lack of efficacy), as nonresponse; whereas, missing data due to other reasons (e.g., missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.
Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
After week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (e.g., no placebo comparisons, patients remaining in the study may be those with better results).
LDI-B=Leeds Dactylitis Index-Basic.
mNRI=modified nonresponder imputation.
In an mNRI analysis of patients receiving Taltz, 83% of patients achieved LDI-B=0 at week 52 and 77% at week 108.
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CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.