TY - JOUR
T1 - Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis
T2 - 3-year results from the phase 3 C-axSpAnd study
AU - van der Heijde, D. sirée
AU - Gensler, Lianne S.
AU - Maksymowych, Walter P.
AU - Landewé, Robert
AU - Rudwaleit, Martin
AU - Bauer, Lars
AU - Kumke, Thomas
AU - Kim, Mindy
AU - Auteri, Simone Emanuele
AU - Hoepken, Bengt
AU - Deodhar, Atul
N1 - Funding Information:
1Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands 2Department of Medicine/Rheumatology, University of California San Francisco, San Francisco, California, USA 3Department of Medicine, University of Alberta, Edmonton, Alberta, Canada 4Rheumatology Department, Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands 5Rheumatology, Zuyderland Medical Centre, Heerlen, The Netherlands 6Department of Internal Medicine and Rheumatology, University of Bielefeld, Bielefeld, Germany 7UCB Pharma, Monheim am Rhein, Germany 8UCB Pharma, Smyrna, Georgia, USA 9UCB Pharma, Milan, Italy 10Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA Acknowledgements The authors thank the patients, the investigators and their teams who took part in this study. The authors also acknowledge Luke Green, PhD, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction. This study was funded by UCB Pharma.
Funding Information:
Competing interests DvdH: consultant of AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma. Director of Imaging Rheumatology BV. LSG: research grants from Novartis, Pfizer and UCB Pharma. Consulting fees from AbbVie, GSK, Janssen, Lilly, Novartis, Pfizer and UCB Pharma. WPM: grants from AbbVie, Novartis and Pfizer. Consulting fees from Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly and UCB Pharma. Honoraria/speakers’ bureau from AbbVie, Novartis, Pfizer and UCB Pharma. Chief Medical Officer for CARE Arthritis Limited. RL: grants from Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. Consultancy fees from Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. Honoraria/speakers’ bureau from Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. MR: consulting fees from UCB Pharma. Honoraria/speakers’ bureau AbbVie, Eli Lilly, Janssen, Novartis and UCB Pharma. Participation on a Data Safety Monitoring or Advisory Board for AbbVie, Eli Lilly, Janssen-Cilag, Novartis and UCB Pharma. LB, BH, TK, MK, SEA: employees and stockholders of UCB Pharma. AD: grants from Abbvie, Eli Lilly, GSK, Novartis, Pfizer and UCB Pharma. Consulting fees from AbbVie, Amgen, Aurinia, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma. Speaker for Janssen, Novartis and Pfizer.
Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/3/16
Y1 - 2022/3/16
N2 - BACKGROUND: 52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and/or elevated C-reactive protein levels). Long-term safety and clinical outcomes, including MRI assessments, are evaluated up to 3 years for CZP-treated patients with nr-axSpA. METHODS: C-axSpAnd was a phase 3 study comprising a 1-year double-blind, placebo-controlled period and 2-year open-label safety follow-up extension (SFE). At baseline, 317 patients were randomised 1:1 to placebo or CZP 200 mg every 2 weeks. Patients completing the double-blind phase who enrolled into the SFE received open-label CZP for an additional 104 weeks. Long-term safety and clinical outcomes are reported to Week 156. Continuous outcomes are presented as observed case (OC) and dichotomous outcomes as OC and with non-responder imputation. RESULTS: 243/317 (76.7%) patients entered the SFE, during which 149 (61.3%) experienced ≥1 treatment-emergent adverse event (TEAE); 15 (3.3/100 patient-years) experienced serious TEAEs. Continuous outcome scores (including Ankylosing Spondylitis Disease Activity Score [ASDAS]: 1.8; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 2.7) at Week 52 were maintained at Week 156 (ASDAS: 1.8; BASDAI: 2.6) for the initial CZP-randomised group. Mean SPARCC MRI sacroiliac joint inflammation scores for these patients decreased at Week 52 (baseline: 7.6; Week 52: 1.7), remaining low at Week 156 (2.4). CONCLUSIONS: CZP treatment was well tolerated up to 3 years, with no new safety signals versus previous reports. Clinical outcomes achieved after 1 year were sustained to 3 years. TRIAL REGISTRATION NUMBER: NCT02552212.
AB - BACKGROUND: 52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and/or elevated C-reactive protein levels). Long-term safety and clinical outcomes, including MRI assessments, are evaluated up to 3 years for CZP-treated patients with nr-axSpA. METHODS: C-axSpAnd was a phase 3 study comprising a 1-year double-blind, placebo-controlled period and 2-year open-label safety follow-up extension (SFE). At baseline, 317 patients were randomised 1:1 to placebo or CZP 200 mg every 2 weeks. Patients completing the double-blind phase who enrolled into the SFE received open-label CZP for an additional 104 weeks. Long-term safety and clinical outcomes are reported to Week 156. Continuous outcomes are presented as observed case (OC) and dichotomous outcomes as OC and with non-responder imputation. RESULTS: 243/317 (76.7%) patients entered the SFE, during which 149 (61.3%) experienced ≥1 treatment-emergent adverse event (TEAE); 15 (3.3/100 patient-years) experienced serious TEAEs. Continuous outcome scores (including Ankylosing Spondylitis Disease Activity Score [ASDAS]: 1.8; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 2.7) at Week 52 were maintained at Week 156 (ASDAS: 1.8; BASDAI: 2.6) for the initial CZP-randomised group. Mean SPARCC MRI sacroiliac joint inflammation scores for these patients decreased at Week 52 (baseline: 7.6; Week 52: 1.7), remaining low at Week 156 (2.4). CONCLUSIONS: CZP treatment was well tolerated up to 3 years, with no new safety signals versus previous reports. Clinical outcomes achieved after 1 year were sustained to 3 years. TRIAL REGISTRATION NUMBER: NCT02552212.
KW - certolizumab pegol
KW - spondylitis, ankylosing
KW - tumour necrosis factor inhibitors
UR - https://www.scopus.com/pages/publications/85126650780
U2 - 10.1136/rmdopen-2021-002138
DO - 10.1136/rmdopen-2021-002138
M3 - Article
C2 - 35296532
SN - 2056-5933
VL - 8
JO - RMD open
JF - RMD open
IS - 1
M1 - e002138
ER -