Is NRS30 Valid for Assessing Treatment Effect for Hidradenitis Suppurativa Pain?
Achievement of NRS30 at week 16 associated with moderate-to-large improvements in clinical, patient-reported outcome measures
By Dermsquared Editorial Team | August 23, 2023
WEDNESDAY, Aug. 16, 2023 -- For adults with moderate-to-severe hidradenitis suppurativa (HS), Numerical Rating Scale (NRS) 30, defined as a ≥30 percent and ≥2-point reduction in skin pain, is valid for assessing HS treatment effect with respect to pain, according to a research letter published online Aug. 11 in the Journal of the American Academy of Dermatology.
Xiaoling Wei, from Novartis Pharma Shanghai, and colleagues examined data from two phase 3 trials of secukinumab to assess the clinical validity of NRS30. Data were included for adults with moderate-to-severe HS from the SUNSHINE and SUNRISE trials (541 and 543 patients, respectively).
The researchers found that the mean NRS pain at baseline was 6.1 ± 1.84 and 6.3 ± 1.78 in SUNSHINE and SUNRISE, respectively. At the second screening visit and baseline, two weeks apart before treatment initiation, strong test-retest reliability was observed for the NRS30 definition (intraclass correlation, 0.81). Construct validity of NRS30 was well supported, with moderate correlation seen with most patient-reported outcomes (PROs); in both trials, the strongest correlations were seen for the Dermatology Life Quality Index (DLQI) and Patient Global Impression of Severity. Achievement of NRS30 at week 16 was associated with moderate-to-large improvements in most clinical and PRO measures; NRS30 nonresponders had small improvements. NRS30 responders at week 16 were more likely to achieve NRS30 response, not experience pain or discomfort, and have improved DLQI scores at 52 weeks.
"Measuring pain on the NRS scale before and after an intervention is a simple and reliable approach for physicians and patients to assess treatment success in the clinical setting," the authors write.
All authors are employees of Novartis, which funded the study.