Taltz® (Ixekizumab)

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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.

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General Information

  • 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.

Phase 3 Clinical Trials

In an integrated analysis of safety data from 3 pivotal phase 3 clinical trials which had an induction period of 12 weeks, 2 of which were followed by a randomized withdrawal maintenance period of 48 additional weeks, the EAIR per 100 PYs for TEAEs and SAEs remained stable or decreased over time through week 60 (Incidence Rates of Treatment-Emergent Adverse Events and Serious Adverse Events Through Week 60 in Phase 3 UNCOVER Clinical Trials).

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

Event

12-Week Induction Period From UNCOVER-1, UNCOVER-2, and UNCOVER-3

48-Week Maintenance Period From UNCOVER-1 and UNCOVER-2

Placebo
(N=791; 180 PY)

IXE Q2W
(N=1167; 269 PY)

IXE Q4W
(N=1161; 266 PY)

Placebo
(N=402; 188 PY)

IXE Q4W
(N=416; 345 PY)

IXE Q12W
(N=408; 282 PY)

Any TEAE, IRa

205.5

253.6b

256.8b

123.8

95.6b

106.2

Any SAE, IRa

6.7

7.4

9.8

8.0

7.5

8.1

Abbreviations: IR = incidence rate; IXE = ixekizumab; PY = patient-years; Q2W = every 2 weeks; Q4W = every 4 weeks; Q12W = every 12 weeks; SAE = serious adverse event; TEAE =-treatment-emergent adverse event.

aIncidence rates were calculated by dividing the total number of patients experiencing the TEAE by the sum of all patients’ time (in 100 years) of exposure during the treatment period.

bp<.05 vs placebo.

UNCOVER-3 Open-Label Long-Term Extension Data 

Treatment-Emergent Adverse Events, Serious Adverse Events, Deaths, and Discontinuations in the Open-Label Long-Term Extension Period of UNCOVER-3 summarizes safety data on TEAEs, SAEs, deaths, and discontinuations due to AEs from the open-label long-term extension period of the 264-week UNCOVER-3 trial for the patients who received the approved ixekizumab dosing regimen and all patients who received ixekizumab.

Treatment-Emergent Adverse Events, Serious Adverse Events, Deaths, and Discontinuations in the Open-Label Long-Term Extension Period of UNCOVER-3

Event

Approved IXE Dosing Regimena LTE Period
1493.8 PY
n (IR)b

All IXE Exposure Population
5179.6 PY
n (IR)b

Patients with ≥1 TEAE

323 (21.6)

1134 (21.9)

Patients with ≥1 SAE

55 (3.7)

253 (4.9)

Deaths

3 (0.2)

11 (0.2)

Discontinuation due to AE

33 (2.2)

131 (2.5)

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.

Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriasis Ixekizumab Exposures Integrated Analysis Set provides the numbers of TEAEs, SAEs, deaths, and discontinuations due to an AE as of March 19, 2020 in the all psoriasis integrated exposures dataset.

Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriasis Ixekizumab Exposures Integrated Analysis Set

Event, n [IR]a

Pooled IXE
N=6645
17,902 PYb

Patients with ≥1 TEAE

5626 [31.4]c

Patients with ≥1 SAE

963 [5.4]

Deaths

35 [0.2]

Discontinuation due to AE

510 [2.8]

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

Event, n [IR]a

Pooled IXE
N=6645
17,902 PYb

Infections

4184 [23.4]

Serious infections

228 [1.3]

Candida infections

335 [1.9]

Potential opportunistic infections

529 [3.0]

Injection site reactionsc

1004 [5.6]

Allergic/hypersensitivity reactions

941 [5.3]

Cytopeniasd

133 [0.7]

Malignancies

139 [0.8]

MACEe

90 [0.5]

Depressionf

218 [1.2]

Inflammatory bowel diseaseg

35 [0.2]

Ulcerative colitis

18 [0.1]

Crohn's disease

17 [0.1]

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.

eConfirmed events.

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.

Incidence Rates of Select Categories of Adverse Events at 1-Year Intervals, All Psoriasis Program Patients Exposed to Ixekizumab With Up To 5 Years of Treatment

Abbreviations: IBD = inflammatory bowel disease; IR = incidence rate; IXE = ixekizumab; MACE = major adverse cerebro-cardiovascular events; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

Note: Inflammatory bowel disease IR summarized here is unadjudicated events.

References

Glossary

AE = adverse event

EAIR = exposure adjusted incidence rate

PY = patient-years

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Appendix: Clinical Trial Brief Descriptions 

Study Design of Induction (UNCOVER-1, -2, and -3) and Maintenance (UNCOVER-1 and -2) Dosing Periods

Abbreviations: ETN = etanercept; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; IXE Q12W = ixekizumab 80 mg every 12 weeks; PBO = placebo; R = randomization; sPGA = static Physician Global Assessment.

Notes:
Etanercept arm was not included in UNCOVER-1.

Responders (sPGA 0 or 1) to ixekizumab at week 12 were rerandomized to receive IXE Q4W, IXE Q12W, or PBO.

In UNCOVER-2 study, nonresponders to ETN at week 12 were switched to IXE Q4W (without a 160-mg starting dose) after a 4‑week washout period.

Nonresponders to PBO at week 12 received a 160-mg starting dose of ixekizumab followed by IXE Q4W.

⁞ (dotted line) indicates relapse (sPGA ≥3).

UNCOVER-3 study is not represented in maintenance period design as the extension period consisted of open-label treatment with IXE Q4W.

Fecha de la última revisión: 2020 M12 02


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