Taltz® (Ixekizumab)

Para consultar la información para prescribir completa de Taltz® (Ixekizumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Ixekizumab: Effect of Ixekizumab on Axial Disease and Physical Function in Psoriatic Arthritis Patients

In patients with active psoriatic arthritis and self-reported axial pain, ixekizumab treatment demonstrated significantly greater improvements than placebo in patient-reported fatigue, axial pain, stiffness, and physical function.

MX_cFAQ_IXE422_BASELINE_BASDAI_PsA
MX_cFAQ_IXE422_BASELINE_BASDAI_PsA
es-MX

Ixekizumab Psoriatic Arthritis Clinical Trial Information

This medical response may not completely match the information in the current local labeling for IXEKIZUMAB. Please see local labeling for approved label information.

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

SPIRIT-P1 (N=417) was a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm, conducted in patients with active PsA who were 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) was a phase 3, 24-week double-blind, placebo-controlled trial, conducted in patients with active PsA and an inadequate response or intolerance to TNF inhibitors, 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

Post Hoc Integrated Analyses in Psoriatic Arthritis Patients With Axial Disease Symptoms

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

  • self-reported baseline axial pain (≥4 BASDAI question 2)
  • a hsCRP level >5mg/L, and
  • self-reported axial pain prior to age of 45.4

As shown in Efficacy Results for the Integrated SPIRIT-P1 and SPIRIT-P2 Subset of Patients With Psoriatic Arthritis Who Had Self-Reported Axial Pain at Baseline, MMRM Analysis, ixekizumab treatment demonstrated significantly greater improvements in axial pain, fatigue, and stiffness than placebo based on the BASDAI questionnaires. Total BASDAI scores were also improved. Physical function was also improved at weeks 16 and 24 as evidenced by improved HAQ-DI scores and SF-36 PCS.4

These analyses were limited by a lack of baseline axial imaging.4

Efficacy Results for the Integrated SPIRIT-P1 and SPIRIT-P2 Subset of Patients With Psoriatic Arthritis Who Had Self-Reported Axial Pain at Baseline, MMRM Analysis4

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

-2.80a

-3.28a

-3.32b

-3.53b

Question 1 (fatigue)

-0.53

-1.07

-1.84c

-2.17 

-2.52b

-2.72a

Question 2 (axial pain)

-1.26

-1.85

-3.25a

-3.53c

-3.19a

-3.45c

Question 5/6 (stiffness)

-0.32

-0.86

-2.40a

-3.09a

-3.01b

-3.16b

HAQ-DI

-0.02

-0.15

-0.40a

-0.52c

-0.52b

-0.51c

SF-36 PCS

1.53

3.64

15.56c

22.38a

18.33b

17.26c

Abbreviations: BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; HAQ-DI = Health Assessment Questionnaire Disability Index; IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; MMRM = mixed-effects model for repeated measure; PBO = placebo; SF-36 PCS = Short Form 36 physical component summary.

Results are presented as Least Squares Mean change from baseline.

ap<.01 vs PBO.

bp<.001 vs PBO.

cp<.05 vs PBO.

Another integrated post hoc analysis was conducted for patients in SPIRIT-P1 and SPIRIT-P2 with baseline

  • BASDAI question 2 (back pain) ≥4, and
  • average of BASDAI questions 5 and 6 (intensity and duration of morning stiffness in the spine) ≥4.5

As shown in Change From Baseline in BASDAI- and ASDAS-Related Endpoints in Patients With Psoriatic Arthritis With Axial Symptoms, mBOCF Analysis , improvements in axial symptoms, as measured by BASDAI questions and ASDAS, were significantly (p<.001) greater in patients treated with ixekizumab vs placebo at weeks 16 and 24, and improvements were sustained at week 52.5

Additionally, significantly (p<.001) more ixekizumab-treated patients achieved BASDAI50 and had improvements in SF-36 PCS at weeks 16 and 24 with responses sustained at week 52 (data not shown).5

Furthermore, similar improvements in BASDAI, ASDAS, and SF-36 PCS were observed for patients with PsA with more restrictive criteria for axial symptoms (baseline elevated CRP >5 mg/L and age <45 years) (data not shown).5

Change From Baseline in BASDAI- and ASDAS-Related Endpoints in Patients With Psoriatic Arthritis With Axial Symptoms, mBOCF Analysis5 

Abbreviations: ASDAS = Ankylosing Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; IXE Q4W = ixekizumab every 4 weeks; LSM = least squares mean; mBASDAI = modified Bath Ankylosing Spondylitis Disease Activity Index; mBOCF = modified baseline observation carried forward; PBO = placebo; Q = question.

p<.001 vs PBO.

References

1Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. 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

2Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, 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

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

4Deodhar A, Ogdie A, Muram T, 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. Ann Rheum Dis. 2019;78(suppl 2):1838. https://ard.bmj.com/content/78/Suppl_2/1838.1

5Deodhar A, Gladman D, Bolce R, et al. Ixekizumab efficacy on spinal pain, disease activity, and quality of life in patients with psoriatic arthritis presenting with symptoms suggestive of axial involvement. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

Glossary

ASDAS = Ankylosing Spondylitis Disease Activity Score

BASDAI = Bath Ankylosing Spondylitis Disease Activity Index

BASDAI50 = 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index

bDMARD = biologic disease-modifying antirheumatic drug

CRP = C-reactive protein

HAQ-DI = Health Assessment Questionnaire-Disability Index

hsCRP = high sensitivity C-reactive protein

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

SF-36 PCS = Short Form 36 physical component summary

TNF = tumor necrosis factor

Fecha de la última revisión: 2021 M06 04


Contáctenos para saber más de la información Médica de Lilly

Contacto vía correo electrónico

Correo electrónico: infomed@lilly.com

Envíe su consulta

Escriba su consulta