title: Effectiveness of Adalimumab in Non-radiographic Axial Spondyloarthritis: Evaluation of Clinical and Magnetic Resonance Imaging Outcomes in a Monocentric Cohort.
abstract: The primary aim of the study was to evaluate the long-term effectiveness of adalimumab (ADA) in a cohort of non-radiographic axial spondyloarthritis (nr-axSpA), and the secondary aims were to identify predictive factors of response and evaluate radiological progression.We evaluated 37 patients (male/female: 12/25; mean age 49 ± 14; mean disease duration: 6.3 ± 5.8) with active nr-axSpA (Assessment of SpondyloArthritis International Society criteria), despite the treatment with ≥1 nonsteroidal anti-inflammatory drug for at least 3 months, initiating the treatment with ADA 40 mg every other week. Patients were treated for 24 months, and evaluated at baseline, 6, 12, and 24 months. Outcome measures included Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index. Radiograph of the spine and sacroiliac joints and magnetic resonance of the sacroiliac joints were performed at baseline and according to the standard of assessment for the disease.The proportion of patients that achieved a BASDAI50 response at 6, 12 and 24 months was 51.3%, 70.3%, and 76.8%, respectively. Treatment was well tolerated with no unexpected adverse events and/or serious adverse events. All patients remained on treatment for 2 years, with a good compliance. We did not identify any predictive factor of response to therapy. Moreover, modified Stoke Ankylosing Spondylitis Spine Score and Spondyloarthritis Research Consortium of Canada scores showed a trend of improvement during the study period.ADA was effective on clinical and radiological outcomes at 2-year follow-up; thus, early treatment with ADA may prevent radiographic damage and be associated with low disease activity or remission. Moreover, data from this cohort study have confirmed safety and tolerability profile of ADA in nr-axSpA in the long term.
authors.affiliation: From the Rheumatology Unit (LC, MF, BF, AV, MGB, MG), Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena; Rheumatology Unit (RT), Department of Clinical and Experimental Medicine, University of Pisa, Pisa; Rheumatology Research Unit (LC), Department of Clinical and Experimental Medicine, University Federico II, Naples; Rheumatology Unit (FC), Department of Medicine DIMED, University of Padua, Padua; Neuroradiology Unit (GLC), S. Donato Hospital, Cardiovascular and Neurologic Department, Arezzo; Radiology Unit (GF), S. Donato Hospital, Department of Diagnostic and Clinical Pathology, Arezzo; and Rheumatology Unit (LS), Department of Internal Medicine, Arezzo, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Cantarini
authors.forename: Marta
authors.initials: M
authors.lastname: Fabbroni
authors.forename: Rosaria
authors.initials: R
authors.lastname: Talarico
authors.forename: Luisa
authors.initials: L
authors.lastname: Costa
authors.forename: Francesco
authors.initials: F
authors.lastname: Caso
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Cuneo
authors.forename: Bruno
authors.initials: B
authors.lastname: Frediani
authors.forename: Gabriele
authors.initials: G
authors.lastname: Faralli
authors.forename: Antonio
authors.initials: A
authors.lastname: Vitale
authors.forename: Maria Giuseppina
authors.initials: MG
authors.lastname: Brizi
authors.forename: Luciano
authors.initials: L
authors.lastname: Sabadini
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000473:pathology*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012720:Severity of Illness Index; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab