TY - JOUR
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, Atul
N1 - Funding Information:
This study was funded by UCB Pharma. The authors thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. The authors also acknowledge Natasha de Peyrecave, DPhil, UCB Pharma, Slough, UK, for critical review of the manuscript, Alvaro Arjona, PhD, UCB Pharma, Brussels, Belgium for publication coordination and Lucy Berry, MBBS, Costello Medical Consulting, Cambridge, UK for medical writing and editorial assistance. In line with Good Publication Practice Guidelines, the Medical Writer produced an initial draft of the manuscript based on direction from the authors, and iteratively updated this to incorporate the views and comments of the authors, under their guidance and input. The Medical Writer was in frequent contact with the authors, and ensured their opinions and contributions were documented. All costs associated with the development of this manuscript were funded by UCB Pharma.
Funding Information:
Funding: This work was supported by UCB Pharma, who funded the study and this manuscript. UCB Pharma reviewed only for scientific and legal accuracy.
Funding Information:
Disclosure statement: L.P. and B.H. are employees of UCB Pharma. M.D. has received research grants/consulting fees from UCB Pharma, AbbVie, Pfizer, Lilly, Merck and Novartis. OD and L.B. are employees and stockholders of UCB Pharma. D.vdH. has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma, and is the director of Imaging Rheumatology bv. P.J.M. has received consulting and/or speaker fees and/or research support from (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Dermira, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sun, UCB Pharma and Zynerba. A.D. has received research grants from and/or participated in advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB Pharma. R.L. has received consulting fees and/or research grants and/or speaker’s bureau from Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, Glaxo-Smith-Kline, Merck, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. F.VdB. received consultancy and/or speaker fees from Abbvie, Celgene, Janssen, Novartis, Pfizer and UCB. W.P.M. has received consulting fees from AbbVie, Amgern, Eli Lilly, Janssen, Merck, Pfizer, Sanofi and UCB. J.W. has received research grants from and/or participated in advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB Pharma. M.R. has received consulting fees from Abbott, Bristol-Myers Squibb, Janssen, MSD, Pfizer, Roche and UCB Pharma. J.B. has received consulting fees/research grants from Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma. J.S. has received speaker and consulting fees from Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen. A.J.K. has received consulting and/or speaker fees and/or research grants from AbbVie, Celgene, Genetech, Janssen, Merck, Novartis, Pfizer, UCB Pharma, Sanofi and Genzyme.
Publisher Copyright:
© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.
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.
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.
KW - Ankylosing spondylitis
KW - Axial spondyloarthritis
KW - Certolizumab pegol
KW - Non-radiographic axial spondyloarthritis
UR - http://www.scopus.com/inward/record.url?scp=85019013385&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85019013385&partnerID=8YFLogxK
U2 - 10.1093/rheumatology/kex174
DO - 10.1093/rheumatology/kex174
M3 - Article
C2 - 28498975
AN - SCOPUS:85019013385
SN - 1462-0324
VL - 56
SP - 1498
EP - 1509
JO - Rheumatology and Rehabilitation
JF - Rheumatology and Rehabilitation
IS - 9
ER -