Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Effekt av ixekizumab på axial värk och fysisk funktion hos patienter med psoriasisartrit

Hos patienter med aktiv psoriasisartrit och självrapporterad axial värk visade behandling med ixekizumab signifikant större förbättringar än placebo av patientrapporterad trötthet, axial värk, stelhet och fysisk funktion.

Detailed Information

Clinical Trial Information

The safety and efficacy of ixekizumab versus placebo has been evaluated in two phase 3, multicenter, randomized, double-blind, placebo-controlled trials in patients with active PsA.1,2

SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm in patients with active PsA who are naïve to bDMARDs with an extension period of up to 3 years.1

At baseline, 72 (72.7%) patients randomized to ixekizumab Q2W and 87 (84.5%) patients randomized to ixekizumab Q4W had a total BASDAI score >4.3

SPIRIT-P2 (N=363) is a phase 3, 24-week double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to TNF inhibitor, with an extension period of up to 3 years.2

At baseline, 99 (83.2%) patients randomized to ixekizumab Q2W and 100 (83.3%) patients randomized to ixekizumab Q4W had a total BASDAI score >4.3

 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.4

Post hoc Integrated Analysis

A post hoc integrated subgroup analysis was conducted for patients in SPIRIT-P1 and SPIRIT-P2 who

  • self-reported baseline axial pain (≥4 BASDAI question 2),

  • had a hsCRP >5mg/L, and

  • had self-reported axial pain prior to age of 45.5

In patients who met the above criteria, ixekizumab treatment demonstrated significantly greater improvements than placebo in axial pain, fatigue, and stiffness based on the BASDAI questionnaires. Total BASDAI scores were improved as well. Physical function was also improved at weeks 16 and 24 as evidenced by improved HAQ-DI scores and SF-36 PCS. Results are described in  

These analyses were limited by a lack of baseline axial imaging.5

Table 1. Efficacy Results for the Integrated SPIRIT-P1 and SPIRIT-P2 Subset of Patients with Psoriatic Arthritis who Self-reported Axial Pain at Baseline (MMRM analysis).5a





Outcome

PBO (N =32)

IXE Q4W (N= 36)

IXE Q2W (N = 37)

Week 16

Week 24 

Week 16

Week 24 

Week 16

 

Week 24

 

BASDAI total

-0.78 

-1.29 

-2.80 b 

-3.28 b

-3.32 c

-3.53c

Question 1 (fatigue)

-0.53 

-1.07 

-1.84 d

-2.17 

-2.52c

-2.72b

Question 2 (axial pain) 

-1.26 

-1.85 

-3.25 b 

-3.53 d

-3.19b

-3.45d

Question 5/6 (stiffness) 

-0.32 

-0.86 

-2.40 b

-3.09 b

-3.01c

-3.16c

HAQ-DI

-0.02 

-0.15 

-0.40  b

-0.52 d

-0.52 c

-0.51 d

SF-36 PCS

1.53 

3.64 

15.56 d

22.38 b

18.33 c

17.26 d

Abbreviations: BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; HAQ-DI = Health Assessment Questionnaire Disability Index; IXEQ2W = ixekizumab every 2 weeks; IXEQ4W = ixekizumab every 4 weeks; MMRM = mixed-effects model for repeated measure; PBO = placebo; SF-36 PCS = 36-Item Short Form Health Survey Physical Component Summary.

Notes: Results presented as Least Squares Mean change from baseline

a All statistical significance listed and p values vs. placebo

b p<.01 vs PBO.

c p<.001 vs. PBO.

d p<.05 vs PBO.

Therapeutic Indication

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.4

References

1. Mease PJ, van der Heijde D, Ritchlin CT, et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

2. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

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

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

5. Deodhar A, Ogdie A, Geneus V et al. Efficacy of ixekizumab in active psoriatic arthritis (PsA) patients with axial pain starting before age 45: a subgroup analysis of SPIRIT-P1 and SPIRIT-P2 phase 3 clinical trials. Presented as an abstract at: European League Against Rheumatism; June 12 – 15, 2019; Madrid, Spain.

Glossary

BASDAI=Bath Ankylosing Spondylitis Disease Activity Index

bDMARD = biologic disease-modifying antirheumatic drug

HAQ-DI = Health Assessment Questionnaire-Disability Index

hsCRP = high sensitivity C-reactive protein

LSM = least squares means

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

SF-36 PCS = Short Form 36 physical component score

TNF = tumor necrosis factor

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 M05 02


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