Rheumatoid arthritis(RA)is an aggressive autoimmune arthritis,and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects.Low-dose interleukin-2(Ld-IL2)is potentially a ther...Rheumatoid arthritis(RA)is an aggressive autoimmune arthritis,and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects.Low-dose interleukin-2(Ld-IL2)is potentially a therapeutic approach to further improve the disease.This randomized,double-blind,placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active RA.Patients were randomly assigned(1:1)to receive Ld-IL2,defined as a dose of 1 million IU,or placebo in a 12-week trial with a 12-week follow-up.Three cycles of Ld-IL2 or placebo were administered subcutaneously every other day for 2 weeks(a total of 7 doses),followed by a 2-week break.All patients received a stable dose of methotrexate(MTX).The primary outcomes were the proportion of patients achieving the ACR20,DAS28-ESR<2.6,and the change from baseline in CDAI or SDAI at week 24.Secondary endpoints included other clinical responses and safety.The primary outcomes were achieved in the perprotocol population.The improvements from baseline in CDAI and SDAI were significantly greater across time points for the LdIL2+MTX group(n=17)than for the placebo+MTX group(n=23)(P=0.018 and P=0.015,respectively).More patients achieved ACR20 response in the Ld-IL2+MTX group than those in the placebo+MTX group at week 12(70.6%vs 43.5%)and at week 24(76.5%vs 56.5%)(P=0.014).In addition,low Treg and high IL-21 were associated with good responses to Ld-IL2.Ld-IL-2 treatment was well-tolerated in this study.These results suggested that Ld-IL2 was effective and safe in RA.ClinicalTrials.gov number:NCT 02467504.展开更多
Background:We examined attitudes toward the COVID‐19 vaccine,potential factors underlying these attitudes,and ways to increase vaccination willingness in autoimmune inflammatory rheumatic diseases(AIIRD)patients.Met...Background:We examined attitudes toward the COVID‐19 vaccine,potential factors underlying these attitudes,and ways to increase vaccination willingness in autoimmune inflammatory rheumatic diseases(AIIRD)patients.Methods:A multicenter,web‐based,observational survey using an online questionnaire was conducted among AIIRD patients aged≥18 years from May 24,2021,to June 3,2021.Participants were 3104 AIIRD patients(2921 unvaccinated and 183 vaccinated).Results:Of the unvaccinated patients,32.9%were willing to receive the COVID‐19 vaccine,45.0%were uncertain,and 14.8%were unwilling.When vaccination was recommended by physicians,patients'willingness increased to 93.8%.Participants'main concerns were that the vaccine may aggravate AIIRD disease(63.0%)and may cause vaccine‐related adverse events(19.9%).Female patients were less likely to be vaccinated.However,patients who had children aged≤18 years were more willing to be vaccinated.In addition,vaccination willingness was higher in patients with trust in the safety and efficacy of the COVID‐19 vaccine.Notably,183(5.9%)patients were vaccinated.The major vaccination side effects were injection reaction,myalgia,and fatigue.At a median follow‐up of 88(38,131)days,patients'disease activities were stable.Conclusions:The findings show that AIIRD patients were unwilling to receive the COVID‐19 vaccine because of fears of potential disease exacerbation and additional adverse events.Sociodemographic characteristics and concerns about COVID‐19 disease and vaccines had a significant effect on vaccination willingness.展开更多
基金National Natural Science Foundation of China(U1903210,31530020,81701598,31570880,81471601,81801617)Beijing SciTech Program(Z171100000417007,Z191100006619114)Macao Science and Technology Fund(0094/2018/A3).
文摘Rheumatoid arthritis(RA)is an aggressive autoimmune arthritis,and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects.Low-dose interleukin-2(Ld-IL2)is potentially a therapeutic approach to further improve the disease.This randomized,double-blind,placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active RA.Patients were randomly assigned(1:1)to receive Ld-IL2,defined as a dose of 1 million IU,or placebo in a 12-week trial with a 12-week follow-up.Three cycles of Ld-IL2 or placebo were administered subcutaneously every other day for 2 weeks(a total of 7 doses),followed by a 2-week break.All patients received a stable dose of methotrexate(MTX).The primary outcomes were the proportion of patients achieving the ACR20,DAS28-ESR<2.6,and the change from baseline in CDAI or SDAI at week 24.Secondary endpoints included other clinical responses and safety.The primary outcomes were achieved in the perprotocol population.The improvements from baseline in CDAI and SDAI were significantly greater across time points for the LdIL2+MTX group(n=17)than for the placebo+MTX group(n=23)(P=0.018 and P=0.015,respectively).More patients achieved ACR20 response in the Ld-IL2+MTX group than those in the placebo+MTX group at week 12(70.6%vs 43.5%)and at week 24(76.5%vs 56.5%)(P=0.014).In addition,low Treg and high IL-21 were associated with good responses to Ld-IL2.Ld-IL-2 treatment was well-tolerated in this study.These results suggested that Ld-IL2 was effective and safe in RA.ClinicalTrials.gov number:NCT 02467504.
基金Beijing Natural Science Foundation,Grant/Award Number:7192211The study was approved by the ethics committee of Peking University People's Hospital(2018PHB115).
文摘Background:We examined attitudes toward the COVID‐19 vaccine,potential factors underlying these attitudes,and ways to increase vaccination willingness in autoimmune inflammatory rheumatic diseases(AIIRD)patients.Methods:A multicenter,web‐based,observational survey using an online questionnaire was conducted among AIIRD patients aged≥18 years from May 24,2021,to June 3,2021.Participants were 3104 AIIRD patients(2921 unvaccinated and 183 vaccinated).Results:Of the unvaccinated patients,32.9%were willing to receive the COVID‐19 vaccine,45.0%were uncertain,and 14.8%were unwilling.When vaccination was recommended by physicians,patients'willingness increased to 93.8%.Participants'main concerns were that the vaccine may aggravate AIIRD disease(63.0%)and may cause vaccine‐related adverse events(19.9%).Female patients were less likely to be vaccinated.However,patients who had children aged≤18 years were more willing to be vaccinated.In addition,vaccination willingness was higher in patients with trust in the safety and efficacy of the COVID‐19 vaccine.Notably,183(5.9%)patients were vaccinated.The major vaccination side effects were injection reaction,myalgia,and fatigue.At a median follow‐up of 88(38,131)days,patients'disease activities were stable.Conclusions:The findings show that AIIRD patients were unwilling to receive the COVID‐19 vaccine because of fears of potential disease exacerbation and additional adverse events.Sociodemographic characteristics and concerns about COVID‐19 disease and vaccines had a significant effect on vaccination willingness.
