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Pain over 2 years after start of biological versus conventional combination treatment in early rheumatoid arthritis : results from the randomised controlled SWEFOT trial

Olofsson, Tor LU ; Wallman, Johan K LU ; Jöud, Anna LU orcid ; Schelin, Maria EC LU ; Ernestam, Sofia ; van Vollenhoven, Ronald ; Saevarsdottir, Saedis and Lampa, Jon (2021) In Arthritis Care and Research 73(9). p.1312-1321
Abstract

OBJECTIVE: To compare the pain course between methotrexate (MTX)-refractory early rheumatoid arthritis (RA) patients randomised to infliximab (IFX) versus sulfasalazine+hydroxychloroquine (SSZ+HCQ).

METHODS: The randomised, controlled, open-label SWEFOT (SWedish FarmacOTherapy) trial enrolled new-onset RA patients Oct 2002-Dec 2005. After 3 months on MTX, patients not reaching low disease activity (28-joint Disease Activity Score; DAS28≤3.2) were randomised to adding IFX (n=128) or SSZ+HCQ (n=130) and followed for 21 months. Here, outcomes included area-under-the-curve (AUC) for Visual Analogue Scale (VAS) of pain, unacceptable pain (VAS pain>40mm [0-100]); and unacceptable pain despite inflammation control (refractory pain;... (More)

OBJECTIVE: To compare the pain course between methotrexate (MTX)-refractory early rheumatoid arthritis (RA) patients randomised to infliximab (IFX) versus sulfasalazine+hydroxychloroquine (SSZ+HCQ).

METHODS: The randomised, controlled, open-label SWEFOT (SWedish FarmacOTherapy) trial enrolled new-onset RA patients Oct 2002-Dec 2005. After 3 months on MTX, patients not reaching low disease activity (28-joint Disease Activity Score; DAS28≤3.2) were randomised to adding IFX (n=128) or SSZ+HCQ (n=130) and followed for 21 months. Here, outcomes included area-under-the-curve (AUC) for Visual Analogue Scale (VAS) of pain, unacceptable pain (VAS pain>40mm [0-100]); and unacceptable pain despite inflammation control (refractory pain; VAS pain>40+C-reactive protein<10mg/L). Between-group differences were analysed with multivariate regression models.

RESULTS: Overall, 50% of randomised patients (n=258) in the crude setting, reported unacceptable pain at randomisation, declining to 29% at 21 months (p<0.001), when refractory pain constituted 82% of all unacceptable pain. Comparing randomised arms (intention-to-treat analysis), AUC for VAS pain was lower in the MTX+IFX-group (p=0.01), and at 21 months 32% with MTX+IFX and 45% with MTX+SSZ+HCQ had unacceptable pain (adjusted relative risk 0.68 [95%CI:0.51-0.90]; p=0.008). Regarding refractory pain, no between-group differences were observed.

CONCLUSION: Despite active combination treatment, almost 1/3 of new-onset RA patients reported unacceptable pain after 21 months and refractory pain constituted more than 4/5 of this pain load. Adding IFX versus SSZ+HCQ to MTX reduced both cumulative pain and unacceptable pain at 21 months, suggesting less long-term pain for the biological therapy. These results display insufficient effects of current treatment strategies on inflammation-independent pain components, warranting alternative approaches in affected patients.

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author
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Arthritis Care and Research
volume
73
issue
9
pages
10 pages
publisher
John Wiley & Sons Inc.
external identifiers
  • pmid:32433827
  • scopus:85086777634
ISSN
2151-4658
DOI
10.1002/acr.24264
language
English
LU publication?
yes
additional info
This article is protected by copyright. All rights reserved.
id
dd70a71f-67b1-42ac-8eb0-294a03b3f207
date added to LUP
2020-08-24 10:35:44
date last changed
2024-06-13 21:58:36
@article{dd70a71f-67b1-42ac-8eb0-294a03b3f207,
  abstract     = {{<p>OBJECTIVE: To compare the pain course between methotrexate (MTX)-refractory early rheumatoid arthritis (RA) patients randomised to infliximab (IFX) versus sulfasalazine+hydroxychloroquine (SSZ+HCQ).</p><p>METHODS: The randomised, controlled, open-label SWEFOT (SWedish FarmacOTherapy) trial enrolled new-onset RA patients Oct 2002-Dec 2005. After 3 months on MTX, patients not reaching low disease activity (28-joint Disease Activity Score; DAS28≤3.2) were randomised to adding IFX (n=128) or SSZ+HCQ (n=130) and followed for 21 months. Here, outcomes included area-under-the-curve (AUC) for Visual Analogue Scale (VAS) of pain, unacceptable pain (VAS pain&gt;40mm [0-100]); and unacceptable pain despite inflammation control (refractory pain; VAS pain&gt;40+C-reactive protein&lt;10mg/L). Between-group differences were analysed with multivariate regression models.</p><p>RESULTS: Overall, 50% of randomised patients (n=258) in the crude setting, reported unacceptable pain at randomisation, declining to 29% at 21 months (p&lt;0.001), when refractory pain constituted 82% of all unacceptable pain. Comparing randomised arms (intention-to-treat analysis), AUC for VAS pain was lower in the MTX+IFX-group (p=0.01), and at 21 months 32% with MTX+IFX and 45% with MTX+SSZ+HCQ had unacceptable pain (adjusted relative risk 0.68 [95%CI:0.51-0.90]; p=0.008). Regarding refractory pain, no between-group differences were observed.</p><p>CONCLUSION: Despite active combination treatment, almost 1/3 of new-onset RA patients reported unacceptable pain after 21 months and refractory pain constituted more than 4/5 of this pain load. Adding IFX versus SSZ+HCQ to MTX reduced both cumulative pain and unacceptable pain at 21 months, suggesting less long-term pain for the biological therapy. These results display insufficient effects of current treatment strategies on inflammation-independent pain components, warranting alternative approaches in affected patients.</p>}},
  author       = {{Olofsson, Tor and Wallman, Johan K and Jöud, Anna and Schelin, Maria EC and Ernestam, Sofia and van Vollenhoven, Ronald and Saevarsdottir, Saedis and Lampa, Jon}},
  issn         = {{2151-4658}},
  language     = {{eng}},
  month        = {{09}},
  number       = {{9}},
  pages        = {{1312--1321}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{Arthritis Care and Research}},
  title        = {{Pain over 2 years after start of biological versus conventional combination treatment in early rheumatoid arthritis : results from the randomised controlled SWEFOT trial}},
  url          = {{http://dx.doi.org/10.1002/acr.24264}},
  doi          = {{10.1002/acr.24264}},
  volume       = {{73}},
  year         = {{2021}},
}