Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis

4-year outcomes from RAPID-axSpA

Désirée van der Heijde, Maxime Dougados, Robert Landewé, Joachim Sieper, Walter P. Maksymowych, Martin Rudwaleit, Filip Van den Bosch, Jürgen Braun, Philip J. Mease, Alan J. Kivitz, Jessica Walsh, Owen Davies, Lars Bauer, Bengt Hoepken, Luke Peterson, Atulya (Atul) Deodhar

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.

Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported.

Results: Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported.

Conclusion: In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.

Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

Original languageEnglish (US)
Pages (from-to)1498-1509
Number of pages12
JournalRheumatology (Oxford, England)
Volume56
Issue number9
DOIs
StatePublished - Sep 1 2017

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amsonic acid
Safety
Uveitis
Arthritis
Placebos
Quality of Life
Observation
Certolizumab Pegol
Patient Reported Outcome Measures
Therapeutics

Keywords

  • ankylosing spondylitis
  • axial spondyloarthritis
  • certolizumab pegol
  • non-radiographic axial spondyloarthritis

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis : 4-year outcomes from RAPID-axSpA. / van der Heijde, Désirée; Dougados, Maxime; Landewé, Robert; Sieper, Joachim; Maksymowych, Walter P.; Rudwaleit, Martin; Van den Bosch, Filip; Braun, Jürgen; Mease, Philip J.; Kivitz, Alan J.; Walsh, Jessica; Davies, Owen; Bauer, Lars; Hoepken, Bengt; Peterson, Luke; Deodhar, Atulya (Atul).

In: Rheumatology (Oxford, England), Vol. 56, No. 9, 01.09.2017, p. 1498-1509.

Research output: Contribution to journalArticle

van der Heijde, D, Dougados, M, Landewé, R, Sieper, J, Maksymowych, WP, Rudwaleit, M, Van den Bosch, F, Braun, J, Mease, PJ, Kivitz, AJ, Walsh, J, Davies, O, Bauer, L, Hoepken, B, Peterson, L & Deodhar, AA 2017, 'Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA', Rheumatology (Oxford, England), vol. 56, no. 9, pp. 1498-1509. https://doi.org/10.1093/rheumatology/kex174
van der Heijde, Désirée ; Dougados, Maxime ; Landewé, Robert ; Sieper, Joachim ; Maksymowych, Walter P. ; Rudwaleit, Martin ; Van den Bosch, Filip ; Braun, Jürgen ; Mease, Philip J. ; Kivitz, Alan J. ; Walsh, Jessica ; Davies, Owen ; Bauer, Lars ; Hoepken, Bengt ; Peterson, Luke ; Deodhar, Atulya (Atul). / Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis : 4-year outcomes from RAPID-axSpA. In: Rheumatology (Oxford, England). 2017 ; Vol. 56, No. 9. pp. 1498-1509.
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abstract = "Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported.Results: Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65{\%} remained in the study at week 204 (AS: 67{\%}; nr-axSpA: 63{\%}). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1{\%} (non-responder imputation); 83.7{\%} (observed case, OC); ASAS40: 44.0{\%} (non-responder imputation); 68.1{\%} (OC); ASDAS inactive disease: 32.1{\%} (last observation carried forward); 31.4{\%} (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported.Conclusion: In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.",
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T1 - Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis

T2 - 4-year outcomes from RAPID-axSpA

AU - van der Heijde, Désirée

AU - Dougados, Maxime

AU - Landewé, Robert

AU - Sieper, Joachim

AU - Maksymowych, Walter P.

AU - Rudwaleit, Martin

AU - Van den Bosch, Filip

AU - Braun, Jürgen

AU - Mease, Philip J.

AU - Kivitz, Alan J.

AU - Walsh, Jessica

AU - Davies, Owen

AU - Bauer, Lars

AU - Hoepken, Bengt

AU - Peterson, Luke

AU - Deodhar, Atulya (Atul)

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported.Results: Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported.Conclusion: In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

AB - Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported.Results: Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported.Conclusion: In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

KW - ankylosing spondylitis

KW - axial spondyloarthritis

KW - certolizumab pegol

KW - non-radiographic axial spondyloarthritis

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U2 - 10.1093/rheumatology/kex174

DO - 10.1093/rheumatology/kex174

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SP - 1498

EP - 1509

JO - Rheumatology (United Kingdom)

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