Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur påverkar Taltz® (ixekizumab) inflammation (MRT och CRP) vid icke-radiografisk axiell spondyloartrit?

Ixekizumab var inte signifikant bättre än placebo i förändring från baslinjen i CRP-nivå vid vecka 16 och 52. Förändring från baslinje i MR-sakroiliakleder SPARCC-poäng vid vecka 16 och 52 var signifikant större i ixekizumab-grupperna jämfört med placebo.

Detailed Information

Effect of Ixekizumab on Objective Signs of Inflammation

The effect of ixekizumab on objective signs of inflammation was assessed by change from baseline in CRP level at week 16 and 52 and MRI sacroiliac joints SPARCC score at week 16 (major secondary endpoint) and week 52.

  • Ixekizumab was not significantly greater than placebo in change from baseline in CRP level at week 16 and 52 (Table 1).

  • Change from baseline in MRI sacroiliac joints SPARCC score at week 16 and 52 was significantly greater in ixekizumab groups compared with placebo (Table 1).1

Table 1. Change from Baseline in CRP Level and MRI Sacroiliac Joints SPARCC Score at Week 16 and 52 of COAST-X1

 

PBO
N=105

IXE Q4W
N=96

IXE Q2W
N=102

Week 16 

CRP concentration, mg/L (SD)

 -4.80 (1.89)

-8.07 (1.93)a

-7.80 (1.89)b

SPARCC sacroiliac joints score, mean (SD)

-0.31 (0.54)

-3.38 (0.55)c

-4.52 (0.53)d

Week 52

CRP concentration, mg/L (SD)

-4.80 (2.04)

-8.61 (2.0)e

-7.55 (1.97)f

SPARCC sacroiliac joints score, mean (SD)

-1.92 (0.87)

-4.40 (0.73)g

-6.16 (0.71)h

Abbreviations: CRP = C-reactive protein; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; MRI = magnetic resonance imaging; PBO = placebo; SPARCC = Spondyloarthritis Research Consortium of Canada.

a p=.23.

b p=.26.

c p<.0001.

d p<.0001.

e p=.18.

f p=.33.

g p=.0294.

h p=.0002.

COAST-X Inclusion Criteria (Not an all-inclusive list)

COAST-X (N=303) is a phase 3, 52-week double-blind, placebo-controlled trial in patients with nr-axSpA who are naive to bDMARDs.1

Eligible patients were

  • 18 years of age with a physician established axSpA diagnosis,

  • fulfilled ASAS classification criteria for nr-axSpA, and

  • had a treatment history for axSpA for ≥12 weeks.

Other key inclusion criteria were

  • active disease at screening and baseline (defined as BASDAI score ≥4 and total back pain ≥4 on a 0–10 scale), and

  • an inadequate response to 2 or more NSAIDs or a history of intolerance to NSAIDs, but no prior treatment with biologic DMARDs.

Patients were also required to have objective signs of inflammation defined as evidence of sacroillitis on MRI and/or elevated CRP (CRP >5 mg/L). Magnetic resonance images were centrally read, and sacroiliitis was determined using the ASAS definition.

Patients were allowed to continue background medications including NSAIDs, cDMARDs, corticosteroids, and analgesics. Stable doses of background medications were required during the first 16 weeks of the study.1

Baseline CRP Level and MRI Sacroiliac Joints SPARCC Score

Mean CRP level at baseline was similar between treatment groups (Table 2).

Table 2. CRP Level and MRI Sacroiliac Joints SPARCC Score at Baseline and MRI and CRP Stratification at Screening in COAST-X1

Baseline Disease Characteristics

PBO

IXE Q4W

IXE Q2W

CRP, mg/L (SD)

14.3 (24.4)

12.4 (18.0)

12.1 (17.8)

MRI SI joints SPARCC score, mean (SD)

6.2 (9.1)

5.3 (8.3)

7.5 (10.8)

MRI and hsCRP stratification at screening, n (%)abc


MRI positive and hsCRP positive

38 (36)

30 (31)

39 (38)

MRI positive and hsCRP negative 

40 (38)

36 (38)

34 (33)

MRI negative and hsCRP positive

26 (25)

30 (31)

28 (27)

Abbreviations: CRP = C-reactive protein; hsCRP = high-sensitivity C-reactive protein; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; MRI = magnetic resonance imaging; PBO = placebo; SI = sacroiliac; SPARCC = Spondyloarthritis Research Consortium of Canada.

a Randomization stratified by country and MRI or hsCRP status at screening (positive MRI and elevated hsCRP, positive MRI and nonelevated hsCRP, and negative MRI and elevated hsCRP).

b Elevated hsCRP defined as >5.0mg/L.

c One patient in the placebo group and one patient in the ixekizumab Q2W group did not have screening MRIs meeting ASAS criteria for the presence of sacroiliitis. 

 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.2

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

Glossary

ASAS = Assessment of SpondyloArthritis international Society

axSpA = axial spondyloarthritis

BASDAI = Bath Ankylosing Spondylitis Disease Activity Index

bDMARD = biologic disease-modifying antirheumatic drug

cDMARD = conventional disease-modifying antirheumatic drug

CRP = C-reactive protein

DMARD = disease-modifying antirheumatic drug

MRI = magnetic resonance imaging

nr-axSpA = nonradiographic axial spondyloarthritis

NSAID = nonsteroidal anti-inflammatory drug

SPARCC = Spondyloarthritis Research Consortium of Canada

Datum fӧr senaste ӧversyn 2020 M03 20


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