Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Farmakokinetik, effekt och säkerhet för autoinjektor och förfylld spruta

Farmakokinetiken för ixekizumab är liknande när det administreras subkutant med antingen en förfylld spruta eller en autoinjektor.

Therapeutic Indications & Posology

Please refer to Taltz summary of product characteristics for information on indications and respective dosing.1

Detailed Information on Ixekizumab Drug Delivery Devices

Pharmacokinetics

  • A phase 3, open-label study (UNCOVER-A) in 204 patients with moderate-to-severe plaque psoriasis was conducted primarily to evaluate the effect of drug delivery devices, either by autoinjector or PFS, on the PK of ixekizumab. The safety and efficacy profile for both ixekizumab devices was consistent with what has been reported in the pivotal phase 3 trials.2,3

  • In this 12-week open label phase 3 study, patients were randomized to treatment with ixekizumab delivered through either an autoinjector (n=102) or PFS (n=102). The starting dose of ixekizumab was 160 mg at week 0, followed by 80 mg Q2W. Of the 204 randomized patients, 98 patients in the autoinjector group and 94 patients in the PFS group had PK evaluable data and were included in the PK analysis.2 

  • Figure 1 illustrates the ixekizumab mean serum concentration over 14 days following a 160 mg SC dose using either a PFS or autoinjector.

Figure 1. Mean (+/-SD) Serum Ixekizumab Concentration vs Time Profiles for Autoinjector and Prefilled Syringe for First 14 Days2

  • Table 1 summarizes serum PK parameters for both drug delivery devices.

Table 1. Summary of ixekizumab Pharmacokinetic Parameters in Serum with Either a Prefilled Syringe or Autoinjector2

PK Parameter (90% CI)

IXE 80 mg Q2W PFS

N=94

IXE 80 mg Q2W Autoinjector

N=98

Autoinjector to PFS ratio/median difference

Cmax, µg/mL 

15.0 (13.9-16.1)

14.8 (13.8-15.9)

0.97 (0.89-1.06)a

Tmax, day

3.97 (1.88-13.96)b

4.00 (1.88-14.01)b

0.046 (0.01-0.09)c

AUC0-tlast,µg x day/mLd

157 (147-168)

154 (144-165)

0.97 (0.89-1.05)a

Abbreviations: AUC0-tlast = area under the curve up to last time point; Cmax = maximum plasma concentration; IXE = ixekizumab; PFS = prefilled syringe; PK = pharmacokinetics; Q2W = every 2 weeks; Tmax = time of Cmax.

a Geometric Least Squares Mean ratio of autoinjector to PFS (90% CI for ratio).

b Median (minimum-maximum).

c Median difference of autoinjector to PFS (90% CI of difference).

d AUC0-tlast is equal to AUC0–14 days, where the last time point was 14 days ± 24 hr.

Efficacy and Safety

  • At week 12, mean percent improvement in PASI was 

    • 89.3% (95% CI: 83.8–94.9) with the PFS, and

    • 86.9% (95% CI:82.2–91.6) with the autoinjector (p<0.001 vs baseline for both groups, mBOCF).2

  • Similar percentages of patients in the PFS and autoinjector groups reported TEAEs and SAEs (Table 2).2

Table 2. Safety of Ixekizumab Delivered by Either Prefilled Syringe or Autoinjector over 12 Week Treatment Period, Safety Analysis Population2

 

IXE 80 mg Q2W PFS

N=102

IXE 80 mg Q2W Autoinjector

N=102

Discontinued due to AE, n (%)

2 (2.0%)

1 (1.0%)

TEAEs

51 (50.0%)

46 (45.1%)

Mild

23 (22.5%)

25 (24.5%)

Moderate

25 (24.5%)

17 (16.7%)

Severe

3 (2.9%)

4 (3.9%)

SAEs

3 (2.9%)

4 (3.9%)

Abbreviations: AE = adverse event; IXE = ixekizumab; PFS = prefilled syringe; Q2W = every 2 weeks; SAE = serious adverse events; TEAE = treatment-emergent adverse events.

  • The commercially available PFS operates the same way as the PFS used in the clinical trial. Additional features of the commercially available PFS are intended to improve usability and confidence in using the device. These features include

    • an enlarged thumb pad

    • enlarged finger flanges with elastomer bumps

    • a large square barrel, and

    • a large flared needle cap.4

References

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

2. Duffin KC, Bagel J, Bukhalo M, et al. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A) [abstract]. J Eur Acad Dermatol Vernereol. 2017;31(1):107-113. http://dx.doi.org/doi:10.1111/jdv.13768

3. Duffin KC, Bagel J, Bukhalo M, et al. Comparison of the pharmacokinetics of ixekizumab following subcutaneous administration using a prefilled syringe versus an autoinjector in patients with moderate-to-severe psoriasis over 12 weeks. Poster presented at the 74th Meeting of The American Academy of Dermatology, March 4-8, 2016.

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

Glossary

mBOCF = modified baseline observation carried forward

PASI = Psoriasis Area and Severity Index

PFS = prefilled syringe

PK = pharmacokinetics

Q2W = every 2 weeks

SAE = serious adverse event

SC = subcutaneous

TEAE = treatment-emergent adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M10 09


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