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Ixekizumab: Long-Term Safety for Plaque Psoriasis
Exposure-adjusted IR for TEAEs and SAEs remained stable or decreased over time in ixekizumab clinical trials.
Comparisons between treatment periods described for the phase 3 UNCOVER trials summarized in this response are descriptive in nature, and not statistical comparisons.
The long-term safety of ixekizumab has been evaluated in 6645 patients with psoriasis who received ixekizumab up to 5 years (a total of 17,902 PY of ixekizumab exposure). The safety profile is consistent with previous reports in patients who received ixekizumab for the treatment of psoriasis and the rates of reported AEs did not increase with long-term exposure to ixekizumab.
Across the 12-week induction periods of UNCOVER-1, -2, and -3, the 48-week maintenance periods of UNCOVER-1 and -2, and the long-term extension period to week 60 of UNCOVER-3, most TEAEs were mild or moderate in severity and generally did not lead to treatment discontinuation. In all 3 trials, long-term safety was evaluated for up to a total of 5 years in patients who participate through the entire studies.
Incidence Rates of Treatment-Emergent Adverse Events and Serious Adverse Events Through Week 60 in Phase 3 UNCOVER Clinical Trials
12-Week Induction Period From UNCOVER-1, UNCOVER-2, and UNCOVER-3
48-Week Maintenance Period From UNCOVER-1 and UNCOVER-2
Abbreviations: AE = adverse event; IR = incidence rate; IXE = ixekizumab; LTE = long-term extension; PY = patient-years; Q2W = every 2 weeks; Q4W = every 4 weeks; SAE = serious adverse event; TEAE = treatment-emergent adverse event. Notes: Patients may be counted in more than one category. Patients with multiple occurrences of the same event are categorized by the highest severity.
aThe approved ixekizumab dosing regimen for moderate-to-severe plaque psoriasis is ixekizumab 160 mg at week 0, followed by 80 mg Q2W through week 12, and 80 mg Q4W thereafter. In UNCOVER-3, patients were allowed to escalate to Q2W dosing after week 60 and remained on Q2W dosing until study completion or discontinuation. The patients that dose-escalated are included in this approved dosing regimen population.
bIR per 100 PY.
Integrated Analysis of Ixekizumab Exposures
In 15 adult and 1 pediatric ixekizumab clinical trials for psoriasis, 6645 patients received at least 1 dose of ixekizumab, representing 17,902 PY of exposure as of the data cutoff of March 19, 2020.
Abbreviations: AE = adverse event; IR = incidence rate; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event. Notes: Patients may be counted in more than one category. Patients with multiple occurrences of the same event are categorized by the highest severity. Deaths are included among SAEs and among discontinuations due to AEs.
aIR per 100 PY.
bData through March 19, 2020.
cThe most commonly reported TEAEs (IR per 100 PYs) were nasopharyngitis (8.9) and upper respiratory tract infection (5.7).
Adverse Events of Special Interest in All Treatment Periods in All Psoriasis Ixekizumab Exposures Integrated Analysis Set
Abbreviations: EPIMAD = Registre Epidemiologique des Maladies de l'Appareil Digestif; IR = incidence rate; IXE = ixekizumab; MACE = major adverse cerebro-cardiovascular events; MEdDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; SMQ = standardized MedDRA query.
aIR per 100 PY.
bData through March 19, 2020.
cHigh level term.
dBroad, according to SMQ classification.
fBroad, according to SMQ or sub-SMQ classification.
gThe data represent adjudicated cases. According to EPIMAD criteria, events classified as "definite" and "probable" per external adjudication are included when determining IR and were considered positively adjudicated.