Researchers Compare Correlation of Two PROMs With Type 2 Inflammatory Mediators

The 12-item Patient Reported Outcomes in Chronic Rhinosinusitis (CRS-PRO) had a better correlation with type 2 (T2) biomarkers than a more widely used patient-reported outcomes measure (PROM) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to findings published in International Forum of Allergy & Rhinology.

While the total CRS-PRO score had a stronger correlation, the Sino-nasal Outcome Test (SNOT-22) is more widely used. The authors explained that SNOT-22 is a modification of the Rhinosinusitis Outcomes Measure 31 (RSOM-31), which was developed with little input from patients. CRS-PRO was created recently by the authors with input from patients with CRSwNP and it has been validated

“The modifications to the RSOM-31 to generate the SNOT-22 were furthermore driven by physician needs rather than patient driven input which contravenes FDA guidance for PRO instruments acceptable for use as endpoints in clinical trials,” they explained.

In this study, the authors evaluated the correlation of CRS-PRO with T2 inflammatory mediators compared with SNOT-22. CRS-PRO evaluated patients before and after endoscopic sinus surgery (ESS), a minimally invasive surgery that removes nasal polyps. Unfortunately, polyp recurrence is common after ESS with up to 40% of patients have recurrent polyposis 18 months after the surgery.

In this study, the researchers recruited 122 patients (71 without nasal polyps [CRSsNP] and 52 with CRSwNP) who had undergone ESS at Northwestern Memorial Hospital. Middle meatal mucus was collected, and CRS-PRO and SNOT-22 were used to collect PROMs prior to ESS and between six to 12 months after ESS. Scores go as high as 110 in SNOT-22 and 78 in CRS-PRO; for both measures, a higher score indicates greater disease severity.

Patients with CRSwNP were slightly more likely than patients with CRSsNP to have undergone revision surgery (50% vs 32%), but otherwise, the 2 patient populations had no significant differences in age, sex, atopic status, tobacco use, and asthma status.

Prior to ESS, there was no significant difference in SNOT-22 and CRS-PRO scores when comparing CRSwNP and CRSsNP. After ESS, the CRS-PRO and SNOT-22 scores were each significantly lower for patients with CRSwNP.

Prior to ESS, the researchers found the rhino-psychologic subdomain of CRS-PRO was correlated to interleukin (IL)-4, IL-13, and eosinophilic cationic protein, while the rhinologic subdomain of SNOT-22 was only correlated to IL-13 and ECP. In the patients with CRSwNP, the total score of both measures correlated with IL-4, but the CRS-PRO rhino-psychologic subdomain more strongly correlated with IL-4, IL-5, and IL-13 prior to ESS, while SNOT-22’s rhinologic subdomain only correlated with IL-4.

After ESS, the CRS-PRO total score correlated with IL-5 and IL-13. In comparison, the SNOT-22 total score did not correlate with any biomarkers. With patients with CRSwNP, CRS-PRO correlated with IL-5, IL-13, and ECP after ESS; SNOT-22 only correlated with IL-5 and IL-13. The rhino-psychologic subdomain of CRS-PRO correlated with IL-4, IL-5, and IL-13 after ESS. The rhinologic subdomain of SNOT-22 correlated with IL-4, IL-5, IL-13, and ECP.

In patients with CRSsNP, the total scores of CRS-PRO and SNOT-22 did not correlate with any T2 inflammatory biomarkers either pre-ESS or Post-ESS. “Although the CRSsNP subgroup showed no correlation between PROM total scores and T2 inflammation post-ESS, certain domains like the rhino-psychologic subdomain of the CRS-PRO and the SNOT-22 rhinologic subdomain appeared to consistently reflect residual T2 inflammation even among patients with CRSsNP,” the authors noted.

They added that the use of mucus rather than tissue, which traditionally measures inflammatory markers, is one limitation of the study. In addition, not all patients had PROMs pre-ESS available — only 78% had this data available.

“The CRS-PRO has a stronger correlation to type 2 inflammatory mediators in chronic rhinosinusitis as a total instrument as well as to greater individual components compared to the SNOT-22,” the authors concluded.