We wanted to do a prospective open-label study to evaluate if ankylosing spondylitis (AS) patients in clinical remission with twice weekly etanercept (ETN) 25 mg therapy could be changed to weekly regimen or even to every other week regimen without increased dose for injection. Thirty-eight AS patients self-administered 25 mg of ETN (Wyett) subcutaneously. According to the protocol, patients who were in clinical partial remission with twice weekly ETN 25 mg at week 12 and 16 changed to a weekly regimen without a change of the dose. If clinical remission, despite the reduction of the dose, persists at week 24 and 28, patients changed to an every-other-week regimen, continuing with this administration schedule for the entire duration of the study if at week 36 and 46 clinical remission was maintained. At the end of the study, 18 patients (47 %) were still in remission, 4 (10 %) with a weekly regimen, and 14 (37 %) with an every-other-weekly regimen. Our study indicates that a consistent percentage of subjects with AS, treated with ETN 25 mg twice weekly, achieved clinical remission within the first 3 months of therapy, and also, a substantial percentage of these patients maintains the partial remission with an every other week regimen.
Our results show that the main reasons that hinder the dosing interval increase in ETN in PsA patients in sustained clinical remission at standard doses are peripheral polyarthritis pattern and exacerbation of cutaneous manifestations.
Background Etanercept (ETN) has been proven to be highly effective in the treatment of patients with Psoriasic Arthritis (PsA) that continued to be active despite treatment with DMARDDs and NSAIDs. In PsA patients achieving a prolonged remission with ETN 25 mg biweekly may be done a switch to ETN 50 mg weekly, while it can not be done a weekly regimen without increased dose. However emerging data from the common clinical practice, and the results of the few observational studies in literature suggest the possibility of identifying the lowest effective dose of ETN for a considerable percentage of PsA patients. Objectives We wanted to do a prospective open-label study to evaluate if PsA patients in clinical remission with biweekly ETN 25 mg therapy could be switched to weekly regimen or even to every other week regimen without increased dose for injection. Methods 56 PsA patients, classified according to the CASPAR criteria (26 patients (46%) with peripheral poliarthritis, 12 patients (24%) with axial pattern and 16 patients (28%) with peripheral oligoarthritis) were recruited between January 2009 and December 2012 at the Rheumatology Unit of Azienda Ospedaliera Universitaria Senese. Patients had to have a disease duration of >1 year and be age >18 <65 years and had active disease, defined as ≥3 tender joints and ≥3 swollen joints) for the patients with peripheral arthritis and as a BASDAI >4 for the patients with axial involvment, despite conventional treatment. Included patients self-administered 25 mg of ETN (Wyett) subcutaneously. Patients were followed up during 1 year and evaluated at baseline and every 3 months thereafter: at each visit all patients underwent routine joint, general assessment and serum and urine samples: measures of effectiveness included PASI, DAS 28, BASDAI and achievement of clincal remission (value of <2 on a 1-10 point scale in each of four ASAS domain, score BASDAI <2, absence of peripheral arthritis e/o enthesitis, absence of inflammatory extra-articular manifestations, normalization of acute phase reactants (CRP), without taking any additional drug including NSAIDs and CS) According to the protocol, patients, who were in clinical remission with biweekly ETN 25 mg at week 12° and 16°, were switched to an weekly regimen without a change of the dose. If clinical remission, despite the reduction of the dose, persists at week 24° and 28°, patients were switched to an every-other-week regimen, continuing with this administration schedule for the entire duration of the study if at week 36° and week 46° clinical remission was maintained. Results At the end of the study 31 patients (55%) were still in remission, 6 (11%) with a weekly regimen and 20 (37%) with a every-other-weekly regimen. Conclusions Our study indicates that a consistent percentage of subjects with PsA, treated with ETN 25 mg biweekly, achieved clinical remission within the first three months of therapy and also that a substantial percentage of these patients mantains the partial remission with an every-other-week re...
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.