Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality-of-life results of the randomised, controlled, SWEFOT trial.

Karlsson, Johan; Neovius, Martin; Nilsson, Jan-Åke; Petersson, Ingemar; Bratt, Johan; van Vollenhoven, Ronald F; Ernestam, Sofia; Geborek, Pierre

Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality-of-life results of the randomised, controlled, SWEFOT trial.

Mark

Karlsson, Johan ^LU ; Neovius, Martin ; Nilsson, Jan-Åke ^LU ; Petersson, Ingemar ^LU ; Bratt, Johan ; van Vollenhoven, Ronald F ; Ernestam, Sofia and Geborek, Pierre ^LU (2013) In Annals of the Rheumatic Diseases 72(12). p.1927-1933

Abstract: OBJECTIVE: To compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) in patients with early, methotrexate (MTX) refractory rheumatoid arthritis (RA), randomised to addition of infliximab (IFX) or sulfasalazine and hydroxychloroquine (SSZ+HCQ). METHODS: RA-patients with symptoms <1 year were enrolled between 2002 and 2005 at 15 Swedish centres. After 3-4 months of MTX monotherapy, patients with a remaining DAS28>3.2 were randomised to addition of IFX or SSZ+HCQ and followed for 21 months. EQ-5D profiles were collected every 3 months. Between-group comparisons of utility change and accumulated QALYs were performed, using last observation carried forward (LOCF) following protocol breach. Missing data were... (More); OBJECTIVE: To compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) in patients with early, methotrexate (MTX) refractory rheumatoid arthritis (RA), randomised to addition of infliximab (IFX) or sulfasalazine and hydroxychloroquine (SSZ+HCQ). METHODS: RA-patients with symptoms <1 year were enrolled between 2002 and 2005 at 15 Swedish centres. After 3-4 months of MTX monotherapy, patients with a remaining DAS28>3.2 were randomised to addition of IFX or SSZ+HCQ and followed for 21 months. EQ-5D profiles were collected every 3 months. Between-group comparisons of utility change and accumulated QALYs were performed, using last observation carried forward (LOCF) following protocol breach. Missing data were imputed by linear interpolation or LOCF. Sensitivity analyses applying baseline observation carried forward (BOCF) or restricted to completers were conducted. RESULTS: Of 487 patients initially enrolled, 128 and 130 were randomised to IFX or SSZ+HCQ, respectively. Mean utility in the IFX and SSZ+HCQ groups increased from 0.52 (SD 0.27) and 0.55 (SD 0.27) at randomisation to 0.66 (SD 0.25) and 0.63 (SD 0.27) at 21 months (adjusted mean difference favouring IFX 0.04; 95% CI -0.01, 0.09; p=0.15). Average accumulated QALYs were 1.10 (SD 0.37) and 1.07 (SD 0.42) in the IFX and SSZ+HCQ groups, respectively (adjusted mean difference favouring IFX 0.07; 95%CI -0.01, 0.14; p=0.07). BOCF analysis showed similar results, while differences were reversed, though remained statistically non-significant among completers. Dropout rates in the IFX/SSZ+HCQ groups were 30%/43% (p=0.01). CONCLUSIONS: Comparing addition of IFX or SSZ+HCQ to MTX in active early RA, no statistically significant differences in utility or QALY gain could be detected over 21 months. TRIAL REGISTRATION: Registered in WHO database at the Karolinska University Hospital, number CT20080004. (Less)

Please use this url to cite or link to this publication: https://lup.lub.lu.se/record/3347822

author

Karlsson, Johan ^LU ; Neovius, Martin ; Nilsson, Jan-Åke ^LU ; Petersson, Ingemar ^LU ; Bratt, Johan ; van Vollenhoven, Ronald F ; Ernestam, Sofia and Geborek, Pierre ^LU

organization

publishing date

2013

type

Contribution to journal

publication status

published

subject

Rheumatology and Autoimmunity

in

Annals of the Rheumatic Diseases

volume

72

issue

12

pages

1927 - 1933

publisher

BMJ Publishing Group

external identifiers

wos:000326877500011
pmid:23196701
scopus:84887419821
pmid:23196701

ISSN

1468-2060

DOI

10.1136/annrheumdis-2012-202062

language

English

LU publication?

yes

id

67fdd024-58e3-4038-8bf3-60dbd54dfe97 (old id 3347822)

alternative location

http://www.ncbi.nlm.nih.gov/pubmed/23196701?dopt=Abstract

date added to LUP

2016-04-01 09:59:06

date last changed

2024-04-21 00:49:16

@article{67fdd024-58e3-4038-8bf3-60dbd54dfe97,
  abstract     = {{OBJECTIVE: To compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) in patients with early, methotrexate (MTX) refractory rheumatoid arthritis (RA), randomised to addition of infliximab (IFX) or sulfasalazine and hydroxychloroquine (SSZ+HCQ). METHODS: RA-patients with symptoms &lt;1 year were enrolled between 2002 and 2005 at 15 Swedish centres. After 3-4 months of MTX monotherapy, patients with a remaining DAS28&gt;3.2 were randomised to addition of IFX or SSZ+HCQ and followed for 21 months. EQ-5D profiles were collected every 3 months. Between-group comparisons of utility change and accumulated QALYs were performed, using last observation carried forward (LOCF) following protocol breach. Missing data were imputed by linear interpolation or LOCF. Sensitivity analyses applying baseline observation carried forward (BOCF) or restricted to completers were conducted. RESULTS: Of 487 patients initially enrolled, 128 and 130 were randomised to IFX or SSZ+HCQ, respectively. Mean utility in the IFX and SSZ+HCQ groups increased from 0.52 (SD 0.27) and 0.55 (SD 0.27) at randomisation to 0.66 (SD 0.25) and 0.63 (SD 0.27) at 21 months (adjusted mean difference favouring IFX 0.04; 95% CI -0.01, 0.09; p=0.15). Average accumulated QALYs were 1.10 (SD 0.37) and 1.07 (SD 0.42) in the IFX and SSZ+HCQ groups, respectively (adjusted mean difference favouring IFX 0.07; 95%CI -0.01, 0.14; p=0.07). BOCF analysis showed similar results, while differences were reversed, though remained statistically non-significant among completers. Dropout rates in the IFX/SSZ+HCQ groups were 30%/43% (p=0.01). CONCLUSIONS: Comparing addition of IFX or SSZ+HCQ to MTX in active early RA, no statistically significant differences in utility or QALY gain could be detected over 21 months. TRIAL REGISTRATION: Registered in WHO database at the Karolinska University Hospital, number CT20080004.}},
  author       = {{Karlsson, Johan and Neovius, Martin and Nilsson, Jan-Åke and Petersson, Ingemar and Bratt, Johan and van Vollenhoven, Ronald F and Ernestam, Sofia and Geborek, Pierre}},
  issn         = {{1468-2060}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{1927--1933}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{Annals of the Rheumatic Diseases}},
  title        = {{Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality-of-life results of the randomised, controlled, SWEFOT trial.}},
  url          = {{http://dx.doi.org/10.1136/annrheumdis-2012-202062}},
  doi          = {{10.1136/annrheumdis-2012-202062}},
  volume       = {{72}},
  year         = {{2013}},
}

Lund University Publications

LUND UNIVERSITY LIBRARIES

Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in early rheumatoid arthritis: 2-year quality-of-life results of the randomised, controlled, SWEFOT trial.