The Combined Measurement of Total Serum IgG and IgG4 May Increase Diagnostic Sensitivity for Autoimmune Pancreatitis Without Sacrificing Specificity, Compared With IgG4 Alone

Abstract

Until now, there was no international consensus on the diagnostic criteria for autoimmune pancreatitis (AIP). As for serologic criteria, the HISORt criteria use elevated immunoglobulin (Ig) G4 alone, whereas the Asian diagnostic criteria include elevations of total IgG or IgG4, or the presence of autoantibodies. This study was mainly aimed at determining whether the combined measurement of total IgG and IgG4 could increase the diagnostic sensitivity for AIP while maintaining specificity, compared with IgG4 alone. Another aim was to determine the utility of autoantibodies to diagnose AIP. We prospectively measured total serum IgG and IgG4 together in 82 consecutive patients with AIP, and seropositivity was defined as elevation of either total IgG or IgG4. To evaluate specificity in the differentiation of AIP from pancreatic cancer, total serum IgG and IgG4 were prospectively measured in 110 patients with pancreatic cancer. Also, the detection rates of antinuclear antibody (ANA) and rheumatoid factor (RF) were retrospectively reviewed in patients with AIP. In patients with AIP, the sensitivity of IgG4 (> or = 135 mg/dl) was 52.5% (43/82), significantly higher than that (46.3%, 38/82) of total IgG (> or = 1,800 mg/dl) (P<0.05). The sensitivity of combined measurement of total IgG and IgG4 for AIP was 68.3% (56/82), significantly higher than that of IgG4 alone (P<0.05). The specificity of total IgG and IgG4 in the differentiation of AIP from pancreatic cancer was 96.4 and 99.1%, respectively. The specificity of combined measurement of total IgG and IgG4 was 95.5%, and it was not significantly different from that of IgG4 alone (P=0.125). The sensitivity of ANA (> or = 1:80) and RF was 24.4% (19/78) and 20.3% (13/64), respectively. All but one patient who had positive results for ANA or RF also showed elevations of either total IgG or IgG4, respectively. The combined measurement of total serum IgG and IgG4 may increase diagnostic sensitivity without sacrificing specificity, compared with IgG4 alone. However, the measurement of ANA or RF may show no additional benefit when combined with total serum IgG and IgG4.