A Meta-analysis Of The Efficacy And Safety Of Immune Checkpoint Inhibitors In The Treatment Of Tumor Patients With Autoimmune Diseases

Objective:Immune checkpoint inhibitors(ICIs)significantly improved the prognosis of cancer patients,but patients combined with autoimmune diseases(AD)are often excluded from clinical trials and treatment for its potential risks,so whether this population can receive ICIs treatment is unclear.This study aims to conduct a meta-analysis of the efficacy and safety of ICIs treatment in tumor patients with AD.Methods: We retrieved Pub Med,Embase and The Cochrane Library databases for observational studies on efficacy and safety of ICIS in patients with AD from establishment to March 2021,and the effective data were extracted and statistically analyzed by R software version 4.0.4.Results: A total of 1050 patients with ICIS combined with AD were included in 18 studies.The incidence of any grade of pre-existing AD flare,new ir AEs,or combination of both was 58%(95%CI 51%-64%),with 32%of pre-existing AD exacerbations(95%CI 26%-39%),35% of new ir AEs,(95%CI 26%-45%),and the majority is of mild adverse events of grade 1-2(76% and 69%,respectively).The combined analysis had an ORR of 30%(95%CI 24%-36%),a DCR of 46%(95%CI 39%-54%),and a permanent discontinuation rate of 16%(95%CI 13%-18%)due to severe adverse events.Conclusions: The pre-existing AD flare and new ir AEs are common in ICIS treatment in AD patients,but most of them are mild and controllable,and the clinical response rate is superior A small number of patients need to stop treatment permanently due to severe toxicity.In general,AD is not absolutely contraindicated for ICIs treatment,but there is a need for more rigorous monitoring of medication responses and more collaborative management with rheumatoid immunologists.