Taltz ® (ixekizumab) injektion

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

Effekt och säkerhet av ixekizumab demonstrerades oavsett kroppsvikt.

Psoriatic Arthritis

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

In the psoriatic arthritis studies, injection site reactions were more common in subjects with a body weight < 100 kg compared with the group with a body weight ≥ 100 kg (24 % vs. 13 % for the combined Q2W and Q4W groups).  The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in the psoriatic arthritis studies.1

In an analysis of the SPIRIT-P1 and -P2 trials, while there were some statistically significant differences in TEAEs presented between different weight categories, investigators determined these were not clinically important. Weight categories evaluated were

  • <80 kg

  • 80 kg to <100 kg, and

  • 100 kg.2

Among the most commonly-reported TEAEs, there was a statistically significant difference in the number of injection site reactions in 2 of the weight categories (<80 kg and ≥80 kg to <100 kg) compared to placebo (Table 1).2

There were no significant differences across treatment groups for the ≥100-kg weight category.2

Table 1. Incidence of Treatment-Emergent Adverse Events Across Initial 24-Week Treatment Period by Body Weight Subgroups in SPIRIT-P1 and -P22

Body Weight Subgroups 

PBO (N = 224)
n (%)

IXE Q4W (N = 229)
n (%)

IXE Q2W (N = 225)
n (%)

All IXE (N = 454)
n (%)

Number of patients in each weight subgroup

<80 kg

81

88

109

197

80 kg to <100 kg

92

84

77

161

100 kg

51

57

39

96

Treatment-emergent adverse events

<80 kg

47 (58)

60 (68)

77 (71)

137 (70)

80 kg to <100 kg

47 (51)

55 (66)

52 (68)a

107 (67)

100 kg

33 (65)

38 (67)

27 (69)

65 (68)

Most common treatment-emergent adverse events 

Injection-site reaction 

<80 kg

0 (0)

13 (15)a

11 (10)a

24 (12)a

80 kg to <100 kg

0 (0)

7 (8)a

17 (22)ab

24 (15)a

100 kg

1 (2)

2 (4)

4 (10)

6 (6)

Upper respiratory tract infection 

<80 kg

6 (7)

7 (8)

8 (7)

15 (8)

80 kg to <100 kg

5 (5)

4 (5)

4 (5)

8 (5)

100 kg

5 (10)

5 (9)

3 (8)

8 (8)

Abbreviations: 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.

b p<.05 vs IXE Q4W.

 The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for psoriatic arthritis 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. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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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