Background/Purpose: Recognition of flare is important in both daily practice and clinical trial setting. However, there is no clear definition of flare in patients with axial spondyloarthritis. SPARSE was a randomized controlled trial evaluating the NSAID-sparing effect of etanercept in axial spondyloarthritis. All patients had to be on NSAIDs prior to screening and were requested to discontinue their NSAID therapy at screening. The objective of this post-hoc analysis was to evaluate the threshold in the changes in symptomatic outcome measures in case of a restart of NSAID, which was considered as a flare.

Methods: Patients: Axial spondyloarthritis (ASAS criteria) with active disease (BASDAI ≥ 4) refractory to NSAIDs and justifying anti-TNF therapy. Design: Prospective randomized controlled trial. Study period of interest: This analysis was focused on the period between screening and baseline. During this period, patients were requested to stop their NSAID therapy and to restart the NSAID only if they experienced clinical deterioration. In this case, patients were asked to complete a diary. Analysis: The proposal of a meaningful change in symptomatic outcome measures was based on the 75^th percentile technique. The 75^thpercentiles of the change in the evaluated outcome measures between screening and re-starting NSAIDs were examined for the subgroup of patients who were able to stop NSAID therapy for at least 2 consecutive days and subsequently had to restart their NSAID therapy (i.e. those patients who flared). Evaluated outcome measures: The BASDAI score and each component of the BASDAI.

Results:

Of the 128 screened patients, 91 (71.1%) had an available BASDAI at the screening visit and 45 (35.2 %) were able to stop their NSAID therapy for at least 2 consecutive days. Of these 45 patients, 32 optimally completed their diary the day they had to restart their NSAID. The table summarizes the observed values for the study variables at screening and flare (time of NSAID restarting) in these 32 patients.

Variable		Screening	Changes from Screening to Flare
			Absolute	Percentage
BASDAI total score	Mean ± SD	5.8 ± 1.2	0.7 ± 1.2	13 ± 21
	(Median)	(5.8)	(0.8)	(14)
	75th Percentile [95% CI]		1.5 [1.2, 1.9]	28 [20, 38]
BASDAI question #1	Mean ± SD	6.7 ± 1.6	0.8 ± 1.9	23 ± 54
(fatigue)	(Median)	(7.0)	(1.0)	(13.0)
	75th Percentile [95% CI]		2.0 [1.0, 3.0]	25 [17, 67]
BASDAI question #2	Mean ± SD	6.6 ± 1.5	0.8 ± 1.6	16 ± 27
(axial)	(Median)	(7.0)	(1.0)	(14)
	75th Percentile [95% CI]		2.0 [2.0, 2.0]	33 [29, 43]
BASDAI question #3	Mean ± SD	4.3 ± 2.8	0.1 ± 2.5	16 ± 80
(peripheral)	(Median)	(5.0)	(0.0)	(0)
	75th Percentile [95% CI]		2.0 [1.0, 3.0]	50 [13, 100]
BASDAI question #4	Mean ± SD	5.0 ± 2.3	0.9 ± 2.5	43 ± 128
(enthesitis)	(Median)	(5.0)	(1.0)	(17)
	75th Percentile [95% CI]		2.0 [1.0, 3.0]	43 [25, 100]
BASDAI question #5/6	Mean ± SD	6.5 ± 1.7	0.6 ± 1.3	12 ± 23
(morning stiffness)	(Median)	(6.5)	(0.5)	(7)
	75th Percentile [95% CI]		1.5 [1.0, 2.5]	27 [11, 43]

Conclusion: This study suggests that there is no universal change that is applicable to all variables. However, an absolute change of at least 2 on a scale of 10 or a relative change of 30% is indicative of a meaningful symptomatic deterioration for most of the symptomatic variables included in the BASDAI score.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/flare-in-spondyloarthritis-proposal-of-a-meaningful-change-in-symptomatic-outcome-measures-in-axial-spondyloarthritis/