ABSTRACT
Background: Given the progressive change in the management of infammatory diseases,an observational study was conducted on the management of Early Rheumatoid Arthritis (ERA) in Catalonia. Objectives: To know the management of ERA in Catalonia, to assess whether the recommendations of the EULAR/ACR guidelines are followed and to study the causes of management variability,to set improvement objectives. Methods: An observational,descriptive,and cross-sectional study was conduct-ed,with data collection from June 15 to 30, 2021.The rheumatologists' partners of the Catalan Society of Rheumatology were the object of study. An online survey was conducted with 304 members on the management of the ERA. Variables related to the characteristics of the respondents,the derivation and variables of the disease including clinical variables,type of treatment and outcomes used for follow-up including the impact of the SARS-CoV2 pandemic were included. The univariate study was performed using a study of proportions with Pearson's correlation. Results: A total of 105 members (34.5%) responded to the survey.11.6%>60 y, only 7.8% <30y. 99% were in public assistance.The number of rheuma-tologists per service is 7.2[1-17],but 34.2% had< 5 rheumatologists,with a reference population of 200,000-300,000p in 42% of respondents.The number of weekly visits made is 67.5[20-130].42.2% do not have a monographic RA or ERA dispensary and 30.4%not have specialized nursing.Characteristics of ERA:77.5% are derived from primary care(PC),52% have been between 6 weeks,42.1%>3 months.54.9% make a frst visit within 2-4 weeks of PC referral and 14.7%> 8 weeks.100%provide previous analysis,only 47% had had RX performed.98% were previously treated(50.4%NSAIDs + CG,36.1%NSAIDs,12.3% CG).4.3% had GC doses>10 mg/day,11.3%> to 20mg/day.The treatment:DMARDs of choice in 100% is MTX,44.1% start doses of 10mg/week and 3.9%7.5 mg/week.The route of choice is oral(55.9% vs 44.1%).92.2% associate GC and 31.7% have not withdrawn them after 6 m.57.8% consider the maximum of MTX 25mg/W.87.1% use doses<10 mg/day,with the most used dose being 5 mg/day(35.6%).Follow-up after the start of DMARDs is performed 72.5% between 4-6 weeks and 12.7% is performed by nursing.100% use DAS 28 and 53.5% also CDAI.31.4% perform PROs(HAQ 83.3%,RAPID 3 14.3%).The use of systematic ultrasound is collected in 33%, being himself who performs it in 59.9% and an expert rheu-matologist in 46.1%.Finally, when asked about incidence of pandemic in the follow-up,53.3% consider that it is doing the same as before. 46.1% consider that telephone visits are not suitable for the follow-up of the ERAvs14.7% who consider that Yes.When questioning the situations in which they consider them to be appropriate,75.9% that it was adequate in the control after the beginning of the DMARDs.Regarding the treatment of ERA, 66% delayed the onset of biological DMARDs, 72.1% due to difficulty of follow-up and only 8.8% due to an increased risk of infection. When performing the univariate analysis, it is evident that having a monographic dispensary is associated with earlier onset of MTX(p< 0.001)and at doses≥15 mg/W(p = 0.05),greater nursing intervention(p< 0.001),greater use of PROs(p = 0.008)and there is a tendency to a shorter waiting time for frst visits(p = 0.07).It is also associated with not considering telephone visits(p< 0.001), making them in less than 25%(p< 0.0001).Similarly,hospital level is directly proportional to initiation at higher doses of MTX(p< 0.0001),lower use of GC<10mg.Among the rest of the variables, no association has been found. Conclusion: The recommendations of EULAR/ACR in the treatment and follow-up of ERA are consistently followed,although the wide use of MTX orally is striking.It is evident that the variable that most influences the early onset of FAME and at higher doses,is a monographic dispensary,as well as greater presence of nursing and performance of PROs.
ABSTRACT
Background: Many patients with palindromic rheumatism (PR), mainly those with positive autoantibodies, evolve to rheumatoid arthritis (RA). Management of PR is empirical, and hydroxychloroquine (HCQ) is the most used antirheumatic drug. Abatacept (ABA) has been investigated in preclinical RA with good results. There are no randomized clinical trials in PR. Objectives: To present the design of a randomized clinical trial in PR (PALABA study). To describe the characteristics of the patients at study entry. The main objective is to test the hypothesis that ABA can reduce the progression of RA in seropositive (ACPA+ and/or RF+) PR patients in comparison with HCQ. Methods: Phase IV multicenter open label randomized controlled clinical trial with 42 months duration. The enrollment period was 18 months and the open randomized period 24 months. Fourteen spanish centers were included. The sample size was 70 patients (35 per arm). ABA sc 125 mg/week frst year, 125 mg eow second year and HCQ oral 5mg/Kg daily were administered, both therapies in monotherapy. The main inclusion criteria were age >18 years with PR according to Guerne and Weissman modifed criteria and disease evolution >3 and <36 months. Positive ACPA (ELISA or chemiluminescence (CCP2) and/or RF tests are required. Patients with arthritis in ≥1 joint >1 week at baseline, with criteria of other rheumatic diseases, radiographic erosions or previous antirheumatic therapy with synthetic DMARDS were excluded. The main outcome measure is achievement of RA classifcation criteria (EULAR/ACR 2010) at any time during the 24-month follow-up. Secondary outcomes were the number and intensity of joint attacks, adverse events, and effects on serum ACPA and anti-carbamylated antibodies at 0,3,12,24 months of follow-up. STATISTICS: Modifed Full Analysis Set and Per Protocol Population analysis. Results: Patient one was included in June 2018. The inclusion period has been extended until April 2022 due to low recruitment rates, partly due to the COVID-19 pandemic. As of 15 Jan 2022, 51 patients have been randomized and 49 (37F/12M) have received at least one drug dose. The mean onset of symptoms was 9.9±6.3 months. In 22 patients the follow-up time was greater than 12 months. RF and ACPA (CCP2) were positive in 81.6% and 89.8% of patients respectively;24 patients were included in the ABA arm and 25 in the HCQ arm. Seven patients withdrew from the study during follow-up due to: progression to RA (n=3), adverse events (n=2) and other reasons (n=2). The demographic, clinical and laboratory characteristics of PR patients at study entry are shown in Table 1. No signifcant differences in patients' characteristics between arms were observed at enrollment except a higher prevalence of CCP2 in the HCQ arm. Conclusion: We present the design of the frst randomized clinical trial in PR of the efficacy of antirheumatic drugs (ABA vs HCQ) to avoid progression towards RA in patients with a high risk (recent onset PR and positive autoantibody status) of persistent arthritis. The characteristics of patients included until now are similar to those reported in recent onset PR.