title: Is Etanercept 25 mg Once Weekly as Effective as 50 mg at Maintaining Response in Patients with Ankylosing Spondylitis? A Randomized Control Trial.
abstract: OBJECTIVE
  To investigate, in a pilot randomized controlled trial, whether etanercept (ETN) 25 mg once weekly is effective at maintaining a clinical response in patients with ankylosing spondylitis (AS) who have responded to the standard 50 mg dose.
  
  
  METHODS
  Adults with AS not responding to conventional therapies were prescribed ETN 50 mg once weekly for 6 months. Responders as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were randomly assigned to taper to 25 mg once weekly or continue on 50 mg and followed for a further 6 months. The primary outcome measure was maintenance of a 50% reduction in the BASDAI or fall in BASDAI by ≥ 2 units and a ≥ 2-unit reduction in BASDAI spinal pain as measured on a 10-point visual analog scale at 6 months postrandomization.
  
  
  RESULTS
  Of 89 patients assessed for eligibility, 59 were enrolled; 47 (80%) had sufficient clinical response and were eligible for randomization, 24 were assigned to continue receiving ETN 50 mg, and 23 to taper to 25 mg. After 6 months, 20 (83%) of the 50 mg arm maintained clinical response compared with 12 (52%) of the 25 mg arm (a difference of -31%, 95% CI -58% - -5%).
  
  
  CONCLUSIONS
  Although this pilot study demonstrates that treatment with ETN 25 mg was less effective at maintaining treatment response in the stepdown phase, 52% of participants maintained treatment response. Future research should address which patients are suitable for tapering.
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Max
authors.initials: M
authors.lastname: Yates
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Louise E
authors.initials: LE
authors.lastname: Hamilton
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Frances
authors.initials: F
authors.lastname: Elender
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Loretta
authors.initials: L
authors.lastname: Dean
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Helen
authors.initials: H
authors.lastname: Doll
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Alex J
authors.initials: AJ
authors.lastname: MacGregor
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
authors.forename: Joegi
authors.initials: J
authors.lastname: Thomas
authors.affiliation: From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust. karl.gaffney@nnuh.nhs.uk.
authors.forename: Karl
authors.initials: K
authors.lastname: Gaffney
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000068800:Etanercept / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept
keywords: ANKYLOSING SPONDYLITIS; ANTI-TUMOR NECROSIS FACTOR THERAPY; ETANERCEPT; RANDOMIZED CONTROL TRIAL