OP0133 Unacceptable, refractory pain despite inflammation control in early rheumatoid arthritis and its relation to treatment strategy: results from the randomised controlled swefot trial
Authors: T. Olofsson, J.K. Wallman, A. Jöud, M.E. Schelin, S. Ernestam, R. van Vollenhoven, S. Saevarsdottir, J. Lampa
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Pain is a major concern of RA patients and earlier work has defined the level considered not acceptable by patients (unacceptable pain according to the patient acceptable symptom state (PASS)<sup>1</sup>). While a lot of focus has been put on the occurrence and management of inflammatory pain, less is reported on refractory pain despite inflammation control, and its pattern in early RA. <h3>Objectives</h3> The aim of this study was to investigate the prevalence of unacceptable pain despite inflammation control during the first 2 years after treatment start in new-onset RA patient and to compare the impact of biological vs conventional combination therapy on the occurrence of this pain status. <h3>Methods</h3> The SWEFOT (SWedish FarmacOTherapy) trial was designed as a randomised, active-controlled, open-label study, enrolling early (&lt;1 year) RA patients Oct 2002 to Dec 2005 After a 3 month run-in period on methotrexate (MTX), patients reaching DAS28 ≤3.2 continued monotherapy (n=147), while the others were randomised to addition of infliximab (IFX; n=128) or sulfasalazine +hydroxychloroquine (SSZ+HCQ; n=130). Results for disease activity and radiographic data were published earlier. Here, we used a measure of unacceptable pain despite inflammation control as outcome (combining VAS pain &gt;40 mm<sup><sup>1–100</sup></sup> with CRP &lt;10 mg/L,<sup>2</sup> and ≤1 swollen joint (of 28)). When comparing the randomised arms, last observation carried forward in case of protocol breach was used, while for analyses of the whole material we used all data irrespective of protocol breach. Differences in prevalence were analysed by Mc Nemar's test, while differences between patients randomised to IFX vs SSZ+HCQ as well as between EULAR response groups were estimated by logistic regression, adjusting for age, sex and VAS pain at baseline. <h3>Results</h3> In the whole material (including all 3 groups, n=405), the frequency of unacceptable pain despite inflammation control increased gradually from inclusion, reached 12% at 1 year (difference from inclusion; p&lt;0.001), and then remained stable until the 2 year follow-up; at that point accounting for more than half of all unacceptable pain (figure 1). The frequency was unrelated to EULAR response from inclusion to the 2 year follow-up (11.4% of good responders vs 10.4% of non-responders, p=0.95). Furthermore, no difference in unacceptable pain despite inflammation control at 2 years was found between patients randomised to IFX vs SSZ+HCQ, (adjusted odds ratio 1.1 [95% CI: 0.5 to 2.4]; p=0.75). <h3>Conclusions</h3> After 2 years of early active treatment in new-onset RA patient, a substantial portion had unacceptable pain despite inflammation control. This pain status was as common in EULAR good responders as in non-responders and no difference was found between patients randomised to IFX compared to SSZ+HCQ. These data are in line with insufficient effects of current treatment strategies to prevent development of inflammation-independent pain in a subgroup of patients, strongly warranting alternative treatment strategies in these patients. <h3>References</h3> [1] Tubach, et al. Arthritis Care Res2012;64:1699–70. [2] Lourdudoss, et al. Arthritis Care Res. doi:10.1002/acr.23245 <h3>Disclosure of Interest</h3> T. Olofsson: None declared, J. Wallman Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, UCB, A. Jöud: None declared, M. Schelin: None declared, S. Ernestam: None declared, R. van Vollenhoven Grant/research support from: AbbVie, BMS, GSK, Pfizer, UCB, Consultant for: AbbVie, AstraZeneca, Biotest, BMS, Celgene, GSK, Janssen, Lilly, Novartis, Pfizer, UCB, S. Saevarsdottir: None declared, J. Lampa Grant/research support from: AbbVie, Speakers bureau: AbbVie, Eli Lilly, Hospira, MSD, Novartis, Pfizer, Roche, Sandoz, UCB