Background/Purpose

This post-hoc analysis from a randomized trial¹in acute gout asked whether early pain responses predict subsequent pain and investigator global responses.

Methods

Patient assessment of pain captured at 28 hours (the first measurement after 24 hours of dosing) was considered as the “early onset” timepoint and was compared to the patient’s subsequent pain and investigators global assessment of response to therapy (IGART) at Day 5.  Pain was assessed on a Likert scale (none = 0, mild = 1, moderate = 2, severe = 3, extreme = 4) and IGART was assessed on a 0–4 point scale (excellent to none). All patients had moderate or greater pain at entry. Early onset of pain relief was defined as “No worse than mild pain” when patients reported pain as “None = 0 or Mild Pain = 1”.  Of the 150 gout patients, all of whom met the 1977 ACR criteria, randomization assigned patients to either etoricoxib 120 mg daily or indomethacin 150 mg daily in a 1:1 ratio. As the analgesic response was similar for etoricoxib and indomethacin in the primary trial, these arms were pooled for this analysis. The 141 patients with complete follow up data were included. Analyses were conducted in SAS® v.9.3.

Results

Ninety percent (90.1%) of patients with mild or no pain at 28 hours continued with mild or no pain at Day 5, vs. 66.7% of those not reaching mild or no pain at 28 hours. More patients with monoarticular than polyarticular gout reached mild or no pain at 28 hours (Breslow-Day, p=0.008).  Monoarticular gout patients with mild or no pain at 28 hours (98.3%) continued to have mild or no pain at Day 5 vs. 70.6% who did not reach mild or no pain at 28 hours (p<0.001). Patients with polyarticular gout reporting mild or no pain at 28 hours continued with mild or no pain at Day 5 (66.7%), vs. 61.5% who attained mild or no pain at 5 Days without reporting mild or no pain at 28 hours (p=NS). Polyarticular gout responded less well early and late vs. monoarticular gout (Table 1`). Mild or no pain at 28 hours correlated with IGART scores of “very good or excellent” at Day 5. Mild or no pain patients at 28 hours had very good or excellent IGART scores at Day 5 (92.6%) vs. 71.7% without mild or no pain at 28 hours (p<0.001). The trend of early pain response with very good/excellent IGART was consistent for monoarticular and polyarticular gout (Breslow-Day p=0.869). Supportive correlations (Pearson’s) for pain and IGART were r=0.498 at 28 hours and r=0.651 at Day 5 (both p <0.0001). 

Table 1. 28-Hour Pain Onset vs Subsequent Pain Response at Day 5

28-Hour Pain Response	Moderate or Greater Pain at Day 5	Mild or No Pain at  Day 5	Percent Responder	Patient Population
NO (Mod. or > pain)	20	40	66.7%	All Patients With Gout
YES  (Mild or no pain)	8	73	90.1%
		CMH Testa	0.003
		Breslow-Day Test	0.008
NO	10	24	70.6%	Monoarticular Gout
YES	1	59	98.3%
		Chi-Squared Test	<0.001
		Fisher’s Exact Test	<0.001
NO	10	16	61.5%	Polyarticular Gout
YES	7	14	66.7%
		Chi-Squared Test	0.716
		Fisher’s Exact Test	0.768
aCMH test controls for monoarticular/polyarticular gout comparison.

 

Conclusion

Early patient pain response of mild or no pain appeared to predict subsequent pain and investigator responses at 5 Days in monoarticular gout. Early response among polyarticular gout patients did not predict subsequent pain response indicating a potentially less stable pain response. This analysis suggests early re-evaluation after 24 hours and modification of gout treatment would benefit patients

¹Schumacher HR et al. BMJ. 2002;324:1488–92.

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