Adult Dermatology Safety
Data at week 12
IN ADULT PLAQUE PSORIASIS TRIALS
Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo in plaque psoriasis registration trials1
The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.
SAFETY DATA FROM SPIRIT-P1 AND -P2 TRIALS
Overall, patients with psoriatic arthritis had a safety profile consistent with that of adult patients with plaque psoriasis in UNCOVER-1, -2, and -3 trials, except for frequency of influenza (Taltz 1.3%, placebo 0.4%) and conjunctivitis (Taltz 1.3%, placebo 0%).
ADDITIONAL ACTIVE COMPARATOR SAFTEY INFORMATION FROM PLAQUE PSORIASIS CLINICAL TRIALS
In the 2 clinical trials that included Enbrel, an active comparator, the rate of serious adverse events during weeks 0 to 12 was 2% with Taltz and 0.7% with US-approved Enbrel, and the rate of discontinuation from adverse events was 2% with Taltz and 0.7% with US-approved Enbrel.
Data at week 60
IN ADULT PLAQUE PSORIASIS TRIALS
Adverse events during weeks 0 to 60 with Taltz vs placebo1
Among those treated with Taltz, the exposure-adjusted incident rates of adverse events from 13 to 60 weeks were lower than the exposure-adjusted incidence rates from 0 to 12 weeks (1.0 vs 2.5 per subject-year of follow-up).
Long-term data
Safety in Taltz clinical trial adult participants studied for up to 6 years2-4
In the adult plaque psoriasis and psoriatic arthritis safety populations, 6989 patients across 15 clinical trials received Taltz, with a total exposure of 16,586 patient-years (PY).
- In psoriatic arthritis trials, the average duration of exposure was 449 days, with 258 patients having at least 2 years’ exposure
- In adult plaque psoriasis trials, the average duration of exposure was 946 days, with 2981 patients having at least 3 years’ exposure
The safety profile observed in patients with psoriatic arthritis who were treated with Taltz is consistent with the safety profile in patients with adult plaque psoriasis. The exceptions include frequencies of influenza (1.3%) and conjunctivitis (1.3%).
Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.
The reported safety population includes all dosing arms of the Phase 1-3 psoriasis and Phase 3 psoriatic arthritis clinical trials. Not all patients received the recommended dosing regimen consistent with the FDA-approved label.
References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Data on file. Lilly USA, LLC. TAL20171211A. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0019. 4. Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arth Care Res. 2018 (Epub). doi:10.1002/acr.23738.