Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Säkerhet stratifierad efter kroppsvikt hos patienter med psoriasis

Taltz® ▼ (ixekizumab): Säkerhet stratifierad efter kroppsvikt hos patienter med psoriasis

Information from the label

The efficacy and safety of ixekizumab was demonstrated regardless of body weight.1

In the adult plaque psoriasis studies, injection site reactions were more common in subjects with a body weight < 60 kg compared with the group with a body weight ≥ 60 kg (25 % vs. 14 % for the combined Q2W and Q4W groups).1

The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in the plaque psoriasis studies.1

Plaque Psoriasis

An analysis of 3 randomized, controlled clinical trials (UNCOVER-1, -2, and -3) was conducted to evaluate the effect of body weight (<80 kg, ≥80 to <100 kg, and ≥100 kg) on the response to ixekizumab in patients with moderate-to-severe psoriasis.2

The incidence of TEAEs was significantly higher in the ixekizumab and etanercept-treated groups than in the placebo group (Table 1).2

The most frequently-reported TEAEs occurred at similar rates across body weight categories within each treatment group (Table 1).2

The short-term safety profile of ixekizumab was comparable to that of etanercept and was consistent with previous studies of ixekizumab with no safety signals specific to any body weight category (Table 1).2

Table 1. Incidence of Treatment-Emergent Adverse Events Across Initial 12-Week Treatment Period by Body Weight Subgroups in UNCOVER-1, -2, and -32

 Body Weight Subgroups

PBO (N = 789)
n (%)

ETN (N = 739)
n (%)

IXE Q4W (N = 1159)
n (%)

IXE Q2W (N = 1168)
n (%)

Number of patients in each weight subgroup

<80 kg

258

234

354

393

80 kg to <100 kg

280

254

437

425

100 kg

251

251

368

349

Treatment-emergent adverse events

<80 kg

126 (49)

129 (55)a

226 (64)a

235 (60)a

80 kg to <100 kg

124 (44)

133 (52)a

242 (55)a

247 (58)a

100 kg

119 (47)

137 (55)

214 (58)a

199 (57)a

Most common treatment-emergent adverse events

Nasopharyngitis 

<80 kg

25 (10)

20 (9)

34 (10)

44 (11)

80 kg to <100 kg

23 (8)

15 (6)

38 (9)

36 (9)

100 kg

21 (8)

20 (8)

32 (9)

31 (9)

Upper respiratory tract infections

<80 kg

13 (5)

11 (5)

9 (3)

14 (4)

80 kg to <100 kg

7 (3)

7 (3)

16 (4)

19 (5)

100 kg

8 (3)

16 (6)

20 (5)

18 (5)

Injection-site reaction 

<80 kg

7 (3)

30 (13)a

37 (11)a

40 (10)a

80 kg to <100 kg

2 (<1)

28 (11)a

26 (6)a

43 (10)a

100 kg

0 (0)

22 (9)a

25 (7)a

34 (10)a

Serious adverse events

<80 kg

4 (2)

4 (2)

8 (2)

5 (1)

80 kg to <100 kg

4 (1)

4 (2)

11 (3)

6 (1)

100 kg

4 (2)

6 (2)

7 (2)

9 (3)

Discontinuations due to adverse events

<80 kg

2 (<1)

3 (1)

10 (3)

6 (2)

80 kg to <100 kg

3 (1)

1 (<1)

11 (3)

12 (3)

100 kg

4 (2)

5 (2)

3 (<1)

7 (2)

Abbreviations: ETN = etanercept 50 mg twice weekly; IXE Q2W = ixekizumab 80 mg every 2 weeks following starting dose of 160 mg; IXE Q4W = ixekizumab 80 mg every 4 weeks following starting dose of 160 mg; PBO = placebo. 

a p<.05 vs placebo.

The dosing schedule IXEQ4W during the first 12 weeks of treatment (induction phase) is not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 1

References

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

2. Reich K, Puig L, Mallbris L, et al. The effect of bodyweight on the efficacy and safety of ixekizumab: results from an integrated database of three randomised, controlled phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2017;31(7):1196-1207. https://doi.org/10.1111/jdv.14252

Glossary

IXEQ2W = ixekizumab 80 mg every 2 weeks

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 2017 M11 27


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