de Pretis Nicolò, Amodio Antonio, Bernardoni Laura, Campagnola Pietro, Capuano Fabiana, Chari Suresh T, Crinò Stefano, Gabbrielli Armando, Massella Arianna, Topazian Mark, Frulloni Luca
Gastroenterology Unit, Department of Medicine, Pancreas Center, University of Verona, Verona, Italy.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Clin Transl Gastroenterol. 2017 Apr 27;8(4):e90. doi: 10.1038/ctg.2017.17.
Steroids are used to induce remission in autoimmune pancreatitis (AIP). Low-dosage steroid therapy or immunosuppressant (IMs) has been proposed as maintenance therapy to prevent AIP relapse. Few and conflicting data have been published on the efficacy of azathioprine (AZA) in preventing AIP relapse. The aim of this study was to evaluate the indication and efficacy of AZA as maintenance therapy to prevent disease relapse in AIP.
Patients suffering from AIP diagnosed according to the ICDC in type 1, type 2, and not otherwise specified (NOS) were divided in those treated with AZA (AZA group) as maintenance therapy and not treated with maintenance therapy (AZA group). Exclusion criteria were: previous pancreatic surgery, other autoimmune diseases as indication for AZA treatment, and use of IMs different from AZA. Drug safety, clinical and instrumental outcome of AZA patients were evaluated.
A total of 23 patients (18 Males and 5 Females, mean age 54±11 years) in AZA group and 97 (58 Males and 39 Females, mean age 45±18 years) in AZA group were compared. In AZA group, patients were significantly older (P=0.043), type 1 AIP was more frequently diagnosed (87 vs. 51%, P=0.006), sIgG4 higher (758±625 vs. 311±409 mg/dl, P<0.001), other organ involvement (OOI) more frequently observed (83 vs. 48%, P=0.002), with higher frequency of relapse before AZA treatment (78 vs. 14%, P<0.001). Three patients in AZA group required drug discontinuation because of adverse events. Twenty patients were therefore evaluated for outcome. Six out of 20 patients (30%) relapsed after 24±15 months (5 in pancreas and 1 on biliary tract). They were retreated with steroids and continued AZA. Two out of 6 patients (33%) had a second relapse,after respectively 11 months (in pancreas and kidney) and 22 months (in kidney).
AZA is an effective and safe treatment to prevent AIP relapses.
类固醇用于诱导自身免疫性胰腺炎(AIP)缓解。低剂量类固醇疗法或免疫抑制剂(IMs)已被提议作为预防AIP复发的维持疗法。关于硫唑嘌呤(AZA)预防AIP复发疗效的已发表数据很少且相互矛盾。本研究的目的是评估AZA作为预防AIP疾病复发维持疗法的适应证和疗效。
根据国际自身免疫性胰腺炎诊断标准(ICDC)诊断为1型、2型及其他类型(NOS)的AIP患者,分为接受AZA治疗(AZA组)作为维持疗法的患者和未接受维持疗法的患者(非AZA组)。排除标准为:既往胰腺手术史、其他自身免疫性疾病作为AZA治疗指征以及使用除AZA以外的免疫抑制剂。评估AZA治疗患者的药物安全性、临床和影像学结局。
比较了AZA组的23例患者(18例男性和5例女性,平均年龄54±11岁)和非AZA组的97例患者(58例男性和39例女性,平均年龄45±18岁)。在AZA组,患者年龄显著更大(P=0.043),1型AIP的诊断更为频繁(87%对51%,P=0.006),血清IgG4更高(758±625对311±409mg/dl,P<0.001),更频繁观察到其他器官受累(OOI)(83%对48%,P=0.002),AZA治疗前复发频率更高(78%对14%,P<0.001)。AZA组有3例患者因不良事件需要停药。因此对20例患者进行了结局评估。20例患者中有6例(30%)在24±15个月后复发(5例在胰腺,1例在胆道)。他们接受了类固醇再治疗并继续使用AZA。6例患者中有2例(33%)再次复发,分别在11个月后(胰腺和肾脏)和22个月后(肾脏)。
AZA是预防AIP复发的一种有效且安全的治疗方法。