Pain over 2 years after start of biological versus conventional combination treatment in early rheumatoid arthritis : results from the randomised controlled SWEFOT trial
(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.
(Less)
- author
- Olofsson, Tor LU ; Wallman, Johan K LU ; Jöud, Anna LU ; Schelin, Maria EC LU ; Ernestam, Sofia ; van Vollenhoven, Ronald ; Saevarsdottir, Saedis and Lampa, Jon
- organization
- publishing date
- 2021-09-01
- 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
- 2024-09-19 04:33:17
@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>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.</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<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}}, }