PMID- 34715908
OWN - NLM
STAT- MEDLINE
DCOM- 20211108
LR  - 20211108
IS  - 1478-6362 (Electronic)
IS  - 1478-6354 (Print)
IS  - 1478-6354 (Linking)
VI  - 23
IP  - 1
DP  - 2021 Oct 29
TI  - Predictors of long-term clinical response in patients with non-radiographic axial 
      spondyloarthritis receiving certolizumab pegol.
PG  - 274
LID - 10.1186/s13075-021-02650-4 [doi]
LID - 274
AB  - BACKGROUND: Identification of predictive clinical factors of long-term treatment 
      response may contribute to improved management of non-radiographic axSpA 
      (nr-axSpA) patients. This analysis aims to identify whether any baseline 
      characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated 
      C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) 
      enrolled in the C-axSpAnd study are predictive of achieving clinical response 
      after 1 year of certolizumab pegol (CZP). METHODS: C-axSpAnd (NCT02552212) was a 
      phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled 
      period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. 
      Predictors of Week 12 (CZP group only) and Week 52 clinical response were 
      identified using a multivariate stepwise logistic regression analysis. Response 
      variables included Ankylosing Spondylitis Disease Activity Score major 
      improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% 
      response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% 
      response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors 
      assessed included demographic and baseline characteristics and clinical outcomes 
      at Week 12. A p-value <0.05 was required for forward selection into the model and 
      p >/=0.1 for backward elimination. Missing data or values collected after switching 
      to open-label treatment were accounted for using non-responder imputation. 
      Sensitivity analyses accounted for patients with changes in non-biologic 
      background medication. RESULTS: Of 317 enrolled patients, 159 and 158 were 
      randomised to CZP and placebo, respectively. Younger age and male sex were 
      identified as predictors of Week 12 response across all assessed efficacy 
      outcomes in CZP-treated patients. Consistent predictors of Week 52 response, 
      measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen 
      (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also 
      predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally 
      consistent with the primary analysis. In placebo-treated patients, no meaningful 
      predictors of Week 52 response were identified. CONCLUSIONS: In this 52-Week, 
      placebo-controlled study in nr-axSpA patients with elevated CRP and/or active 
      sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not 
      elevated CRP or responses at Week 12, were predictive of long-term clinical 
      response to CZP. Findings may support rheumatologists to identify patients 
      suitable for TNFi treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02552212 
      . Registered on 15 September 2015.
CI  - (c) 2021. The Author(s).
FAU - Maksymowych, Walter P
AU  - Maksymowych WP
AUID- ORCID: 0000-0002-1291-1755
AD  - University of Alberta, Edmonton, Canada. walter.maksymowych@ualberta.ca.
FAU - Kumke, Thomas
AU  - Kumke T
AD  - UCB Pharma, Monheim am Rhein, Germany.
FAU - Auteri, Simone E
AU  - Auteri SE
AUID- ORCID: 0000-0002-2018-7998
AD  - UCB Pharma, Milan, Italy.
FAU - Hoepken, Bengt
AU  - Hoepken B
AD  - UCB Pharma, Monheim am Rhein, Germany.
FAU - Bauer, Lars
AU  - Bauer L
AD  - UCB Pharma, Monheim am Rhein, Germany.
FAU - Rudwaleit, Martin
AU  - Rudwaleit M
AD  - University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02552212
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211029
PL  - England
TA  - Arthritis Res Ther
JT  - Arthritis research & therapy
JID - 101154438
RN  - UMD07X179E (Certolizumab Pegol)
SB  - IM
MH  - Certolizumab Pegol/therapeutic use
MH  - Double-Blind Method
MH  - Humans
MH  - Male
MH  - *Sacroiliitis
MH  - *Spondylarthritis/diagnostic imaging/drug therapy
MH  - *Spondylitis, Ankylosing
MH  - Treatment Outcome
PMC - PMC8556993
OTO - NOTNLM
OT  - Axial spondyloarthritis
OT  - Certolizumab pegol
OT  - Predictors
OT  - TNF inhibitor
COIS- WPM: honoraria/consulting fees from AbbVie, Boehringer-Ingelheim, Celgene, Eli 
      Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; research grants from 
      AbbVie and Pfizer; educational grants from AbbVie, Janssen, Novartis and Pfizer; 
      Chief Medical Officer for CARE Arthritis Limited. TK, SEA, BH and LB: employees 
      of UCB Pharma; own stock awards in UCB Pharma. MR: speakers bureau for AbbVie, 
      Eli Lilly, Novartis and UCB Pharma; consultant of AbbVie, Celgene, Eli Lilly, 
      Janssen, Novartis and UCB Pharma.
EDAT- 2021/10/31 06:00
MHDA- 2021/11/09 06:00
PMCR- 2021/10/29
CRDT- 2021/10/30 05:27
PHST- 2021/06/14 00:00 [received]
PHST- 2021/10/12 00:00 [accepted]
PHST- 2021/10/30 05:27 [entrez]
PHST- 2021/10/31 06:00 [pubmed]
PHST- 2021/11/09 06:00 [medline]
PHST- 2021/10/29 00:00 [pmc-release]
AID - 10.1186/s13075-021-02650-4 [pii]
AID - 2650 [pii]
AID - 10.1186/s13075-021-02650-4 [doi]
PST - epublish
SO  - Arthritis Res Ther. 2021 Oct 29;23(1):274. doi: 10.1186/s13075-021-02650-4.