Background/Purpose

Flares in rheumatoid arthritis (RA) are a patient-perceived increase of disease activity which might be particularly important to assess in the context of treatment tapering. However, there is little data on what patient-perceived flares really encompass. In a treatment tapering study, STRASS, patients were asked about flares, and many validated outcomes were collected.  

The objective was to explore the discrimination properties of different validated outcomes for flares, by comparing these outcomes between visits where patients self-reported flares, and visits without flares, in the STRASS tapering study.

Methods

The STRASS study was a step-down randomized trial (ref). Patients had RA, were treated with adalimumab  or etanercept  for ≥12 months, and were in DAS 28-remission (DAS≤2.6) for ≥6 months. Patients were randomized to either the “spacing”(S) arm (where the TNF blocker was tapered gradually) or the “maintaining”(M) arm, over 18 months. Flares were evaluated through a patient-reported questionnaire every 3 months, asking: “Concerning the last 3 months, did you experience symptoms of a relapse of RA?”. RA outcomes, including HAQ, patient global assessment, SF36, pain, tender joint count, swollen joint count, ESR and CRP were compared between visits with flares and visits without. Cohen’s effect size was calculated for indicative purposes, without adjustment on these repeated measures. Effect size is considered high when above 0.8.

Results

In all, 137 patients were included in STRASS, 64 and 73 in the S and M arms respectively: age (mean±SD) 55±11 yrs, females 78%, RA duration 9±8 years. Over the 18 months of the study, the mean number of visits where the patient reported at least one flare (out of a possible total number of visits of 6 visits) was 1.87±1.74, with 2.44±1.68 visits with flares in the S arm, and 1.37 ±1.65 visits with flares in the M arm (p=0.0001). Overall, 55 patients (88.7%) in the S arm and 40 patients (55.6%) in the M arm reported flares at least once. Comparisons between visits at which patients reported flares, and visits without, showed statistically significant differences concerning all the outcomes, with effect sizes comprised between 0.27 [0.12-0.42] and 1.09 [0.94-1.25] (table). The highest effect sizes were observed for patient global assessment and SF36 PCS, and the lowest for ESR.

Conclusion

Patient-perceived flares are frequent during treatment tapering. Patient-reported outcomes discriminated better between visits with versus without flares, than physician measures or biology. More work is needed on the concept of flares.

Ref: Fautrel B et al. Arthritis Rheum 2013; 65: S1150. 

Table:

	Visits with patient-reported flares. N=256	Visits without patient-reported flares. N=684	Indicative effect size           [95% CI]
Patient global assessment 0-10	2.92 ± 2.41	1.11 ± 1.07	1.09 [0.94-1.25]
SF36 PCS	42.28±8.86	49.70 ± 7.66	-0.91 [-1.13- -0.70]
Tender joint count	4.14 ± 5.73	0.97 ± 2.71	0.78 [0.63-0.94]
Swollen joint count	2.00 ± 3.12	0.41 ± 1.03	0.77 [0.62-0.92]
HAQ	0.67 ± 0.66	0.37 ± 0.53	0.56 [0.35-0.77]
SF36 MCS	43.77 ± 9.96	48.43 ± 10.05	-0.52 [-0.73- -0.30]
CRP, mg/l	5.73 ± 8.96	3.00 ± 3.68	0.44 [0.29-0.59]
ESR, mm	16.54 ± 15.40	13.21 ± 9.72	0.27 [0.12-0.42]

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/what-discriminates-best-flares-in-rheumatoid-arthritis-ra-a-subanalysis-of-the-strass-treatment-tapering-in-ra-study/