ABATACEPT VERSUS HYDROXYCHLOROQUINE in PALINDROMIC RHEUMATISM: A MULTICENTER RANDOMIZED CLINICAL TRIAL (PALABA STUDY): TRIAL DESIGN and PATIENTS CHARACTERISTICS
Annals of the Rheumatic Diseases
; 81:1227, 2022.
Article
in English
| EMBASE | ID: covidwho-2009033
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.
abatacept; autoantibody; cyclic citrullinated peptide antibody; endogenous compound; hydroxychloroquine; achievement; adult; chemoluminescence; clinical trial; conference abstract; controlled study; coronavirus disease 2019; demography; drug combination; drug efficacy; drug therapy; enzyme linked immunosorbent assay; erosion; female; follow up; human; human tissue; major clinical study; male; monotherapy; multicenter study; outcome assessment; pandemic; phase 4 clinical trial; prevalence; randomized controlled trial; rheumatic disease; rheumatoid arthritis; sample size
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Annals of the Rheumatic Diseases
Year:
2022
Document Type:
Article
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