Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Säkerhet och effekt vid behandling av icke-radiografisk axial spondyloartrit hos bDMARD-naiva patienter (COAST-X)

I COAST-X visade sig ixekizumab vara effektivare än placebo i det primära utfallet av andelen patienter som hade uppnått ASAS40-svar i vecka 16.

Short Answer Summary

This response includes efficacy and safety information from COAST-X, a phase 3, 52-week, double-blind, placebo-controlled trial in 303 patients with nr-axSpA who are naive to bDMARDs.1

In COAST-X, ixekizumab was superior to placebo in the primary outcome of the proportion of patients achieving an ASAS40 response at week 16.1

Clinical Trial Data

Efficacy Results

Significantly more patients achieved ASAS40 in the ixekizumab 80 mg Q4W and Q2W treatment groups at weeks 16 and 52 compared with placebo, with higher responses as early as week 1.1 See Figure 1 for ASAS40 response rate through week 52 of COAST-X.1,2

Patients who discontinued the originally-assigned blinded study treatment, and were switched to open-label ixekizumab 80 mg Q2W, were considered nonresponders after switching in the primary analysis.1

Figure 1. ASAS40 Response Rate Through Week 52 of COAST-X, ITT Population, NRI1,2

Abbreviations: ASAS40 = improvement of ≥40% and ≥2 units in ≥3 ASAS domains, with no deterioration in the potential remaining domain; ITT = intent-to-treat; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; NRI = nonresponder imputation; PBO = placebo.
† p<.01 vs PBO.

Safety Results

Compared with the placebo group, more patients in each of the ixekizumab groups reported at least one TEAE. See Table 1 for a summary of TEAEs reported in COAST-X.

Table 1. TEAEs Reported Through Week 52 of COAST-X, Safety Population1,2


PBO
N=104
n (%)

IXE Q4W
N=96
n (%)

IXE Q2W
N=102
n (%)

TEAEs

60 (57)

63 66

79 (77)

Severea

4 (4)

1 (1)

7 (7)

SAEs, n (%)

1 (1)b

2 (2)c

1 (1)d

Discontinuations due to AEs, n (%)

2 (2) 

1 (1)

1 (1)

Death

0

0

0

Common TEAEse


Nasopharyngitis

8 (8)

18 (19)

16 (16)

Injection Site Reactionf

4 (4)

11 (11)

17 (17)

Headache

4 (4)

7 (7)

5 (5)

Upper Respiratory Tract Infection

4 (4)

4 (4)

6 (6)

Hypertension

3 (3)

6 (6)

4 (4)

TEAEs of Special Interest


Neutropeniag




Grade 1 

8 (8)

11 (11)

13 (13)

Grade 2

0

1 (1)

2 (2)

Grade 3

0

0

0

Grade 4

1 (1)

0

0

Infections

30 (29)

38 (40)

43 (42)

Serious Infections

0

1 (1)

0

Opportunistic Infections


Oral Candida

1 (1)

0

0

Herpes Zoster

1 (1)

2 (2)

0

Reactivated TB

0

0

0

Anterior Uveitis

2 (2)

1 (1)

2 (2)

Inflammatory Bowel Diseaseh,i

1 (1)

1 (1)

0

Depressionj

0

0

4 (4)

Malignancies

0

0

0

Allergic Reactions

4 (4)

4 (4)

3 (3)

Potential Anaphylaxis

1 (1)

0

0

Injection Site Reactionsk

7 (7)

18 (19)

25 (25)

Severe

0

0

2 (2)

Cerebrocardiovascular Eventsh

0

0

1 (1)

Hepatic Eventsl

6 (6)

3 (3)

5 (5)

Abbreviations: AE = adverse event; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; SAE = serious adverse event; TB = tuberculosis; TEAE = treatment-emergent adverse event.

a Patients with multiple occurrences of the same event are counted under the highest severity.

b Anaphylactoid reaction.

c Abdominal pain and erysipelas.

d Major depression.

e Common TEAEs are defined as those that occurred at a frequency of ≥5% for patients receiving ixekizumab (both treatment regimens combined).

f MedDRA preferred term.

g Neutropenia percentages were calculated for patients with a baseline and at least one postbaseline value: Placebo=102, ixekizumab Q2W=102, and ixekizumab Q4W=96.

h Adjudicated by external committee.

i Placebo patient had prior history of ulcerative colitis and IXE Q4W patient had prior history of chronic diarrhea. Both patients continued treatment, completed study, and enrolled in long-term extension study.

j One patient with preexisting anxiety in the ixekizumab Q2W arm was discontinued due to a TEAE of suicidal ideation after switching to open-label ixekizumab.

k MedDRA high-level term.

l Patients with at least one hepatic-related TEAE. Most were due to transaminase elevations.

 The dosing schedule IXE Q2W is not consistent with the approved dosing schedule for axial spondyloarthritis. Please refer to the Taltz Summary of Product Characteristics for approved dosing.3

References

1. Deodhar A, van der Heijde D, Gensler LS, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X

2. Deodhar A, van der Heijde D, Gensler L, et al. Ixekizumab in non-radiographic axial spondyloarthritis: Primary results from a phase 3 trial. Talk presented at: American College of Rheumatology/ARP Annual Scientific Meeting; November 8-13, 2019; Atlanta, GA.

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

Glossary

ASAS40 = improvement of ≥40% and ≥2 units in ≥3 ASAS domains, with no deterioration in the potential remaining domain

bDMARD = biologic disease-modifying antirheumatic drug

nr-axSpA = nonradiographic axial spondyloarthritis

Q2W = every 2 weeks

Q4W = every 4 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 2019 M10 01

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