Previous qualitative studies have revealed discrepancies between patients' and physicians' perceptions of rheumatoid arthritis (RA) and its treatment. Questionnaires were administered to 2795 patients with RA (756 from Europe; 2039 from the USA) to measure patients' perceptions regarding pain management in RA. Although the majority of patients reported their RA as somewhat-to-completely controlled, 75% of European and 82% of US patients reported their pain as moderate-to-severe in the previous 2 months. The majority of European (60%) and US (65%) patients reported dissatisfaction with their arthritis pain. Patients' pain levels corresponded with their disease severity. A higher percentage of patients who reported severe pain were being treated for depression than those who had moderate or mild pain. Patients in the USA rated pain relief as the top required benefit from their RA medication. A comprehensive examination of patients' perspectives regarding pain could lead to better patient care and pain management strategies.

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BackgroundGuidelines recommend low-dose, short-term glucocorticoid (GC) treatment for rheumatoid arthritis (RA).1,2 Long-term use, especially at prednisone-equivalent doses >5 mg/d, should be avoided,2 but many patients (pts) with early established RA receive long-term GCs, often ≥5 mg/d.3 ObjectivesCompare GC tapering vs continuation to maintain disease control in RA pts with chronic GC exposure receiving tocilizumab (TCZ) in a randomized controlled trial.MethodsBefore randomization pts had to receive TCZ ± conventional synthetic (cs)DMARDs and GC (prednisone-equivalent dose 5-15 mg/d) for ≥24 wks. At randomization pts had to be in at least low disease activity (LDA: DAS28-ESR ≤3.2) and receiving stable concomitant therapy (prednisone 5 mg/d [GC5mg]) and TCZ ± csDMARDs) for ≥4 wks. Pts were randomized to continue blinded GC5mg for 24 wks or undergo blinded taper (GCtaper, from 4 mg/d with 1-mg reduction every 4 wks to 0 mg/d at wks 16-24) while receiving stable TCZ and csDMARD doses. Pts with RA flare (DAS28-ESR >3.2 and increase >0.6 vs baseline) received open-label rescue GC5mg for 2 wks and continued blinded treatment. Primary outcome was mean change in DAS28-ESR at wk 24. Key secondary outcome was treatment success—DAS28-ESR ≤3.2 at wk 24 and no RA flare during 24 wks and no adrenal insufficiency necessitating replacement therapy.Results259 pts were randomized to GCtaper (n=131) or GC5mg (n=128); 114 and 112, respectively, completed 24 wks. Mean baseline DAS28-ESR was 1.9. Mean RA duration was 9.2 y. For the primary endpoint, the between-arm difference was 0.6 DAS28-ESR units (95% CI, 0.3, 0.9; p<0.001, ANCOVA) favoring GC5mg (Figure). Results were consistent for key subgroups (DAS28-ESR between-arm difference 0.5 [95% CI –0.1, 1.0] for TCZ monotherapy, 0.7 [0.4-1.0] for TCZ + csDMARDs, 0.6 [0.2-1.0] for baseline DAS28 <2, and 0.6 [0.2-1.0] for baseline DAS28 ≥2). Most pts in both arms achieved treatment success (65% GCtaper vs 77% GC5mg; relative risk, 0.83 [0.71-0.97]; p=0.021, Cochran-Mantel-Haenszel test); 11% of GC5mg pts and 26% of GCtaper pts experienced RA flare. One GC5mg pt and no GCtaper pts discontinued blinded treatment due to insufficient flare control. Serious adverse events (no deaths) were reported for 5% of GC5mg vs 3% of GCtaper pts. No pts had symptomatic adrenal insufficiency.ConclusionContinued GC5mg provided better DAS28-ESR control than GC taper in RA pts in LDA or remission. The 0.6 DAS28-ESR unit between-arm difference should be interpreted in the context of approximately two-thirds of tapered pts experiencing treatment success and no tapered pts discontinuing due to lack of flare control. The taper schedule was safe regarding adrenal insufficiency. The results suggest that all pts achieving LDA or remission with TCZ and receiving long-term low-dose GC should be considered for GC tapering, ideally targeting discontinuation.References[1] Singh JA et al. Arthritis Rheum. 2016;68:1.[2] Smolen JS et al. Ann Rheum Dis. 2017;76:960.[3] Buttgereit F, Bijlsma JW. Ann Rheum Dis. 2017;76:1785....

Background Expanded adipose-derived stem cells (eASCs) are shown to have immune-modulatory effects in vitro and in animal models of arthritis. eASCs are currently under investigation as potential treatments targeting auto-immune and inflammatory diseases. Objectives Determine the tolerance, safety and feasibility of intravenous (IV) administration of allogeneic eASCs in Rheumatoid Arthritis (RA) patients. Methods A 24-week, single blind dose-escalating study in refractory RA patients, defined as patients treated with at least one non-biological DMARD and who previously failed to treatment with at least two biologicals, was conducted in 23 centers in Spain. Fifty-three patients with moderate to high disease activity (DAS28>3.2) were assigned to 1x106 eASCs/kg (cohort A: 20 patients), 2x106 eASCs/kg (cohort B: 20 patients), 4x106 eASCs/kg (cohort C: 6 patients) or placebo (Ringer's lactate solution: 7 patients). All patients received 3 IV eASC or placebo infusions at day 1, 8 and 15. Tolerability and treatment emergent adverse events such as Dose Limiting Toxicities (DLTs), serious adverse events (SAEs) and non-serious adverse events (AEs) were primary endpoints. Efficacy measures such as ACR20/50/70, DAS 28, and SF-36 were secondary endpoints. Results Patient and disease characteristics were comparable for all three dose groups. 85.7% were females, the age ranged between 33 years and 78 years (median 56 years, mean 55 years). Time since onset of the disease was between 3.3 and 69.9 years (mean 15.6 years, median 13 years). DAS28 (PCR) disease activity scores at baseline ranged between 3.2 and 7.9. Repeated IV infusion of eASCs did not show any major safety signals and no dose-limiting safety signal was identified. One possibly related SAE, a lacunar infarction in cohort A, lead to discontinuation but the patient recovered. Non-serious related AEs (threshold: >4%) occurring in patients treated with eASCs and more frequently than with placebo, included pyrexia (15%), headache (9%) and malaise, influenza-like illness, pruritus, rash, and respiratory tract infection (4% each). In secondary endpoints, no clinically relevant differences were observed among the three dose regimens. Overall ACR20/50/70 responses were observed in 45/20/5% of patients receiving 1x106 eASCs/kg versus 25/10/0% of patients on placebo at month 1. The DAS 28 remission (<2.6) for the eASC treated group and placebo was 7% versus 0% at month 1 and 11% versus 0% at month 2 respectively. Conclusions These early clinical results are the first evidence suggesting that IV infusion of eASCs may be well tolerated for the treatment of refractory RA. Encouraging results include the absence of major safety signals within 24 weeks and the larger improvement in secondary endpoints in the eASC arms versus placebo. Acknowledgements The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under the grant agreement no. 279174. Disclosure of Interest J.M. Alvaro-Gracia: None declared...

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