title: Corticosteroid transdermal delivery significantly improves arthritis pain and functional disability.
abstract: Arthritis is characterized by pain and functional limitation affecting the patients' quality of life. We performed a clinical study to investigate the efficacy of a betamethasone valerate medicated plaster (Betesil) in improving pain and functional disability in patients with arthritis and osteoarthritis. We enrolled 104 patients affected by osteoarthritis (n = 40) or arthritis (n = 64) in different joints. Patients received diclofenac sodium cream (2 g, four times a day) or a 2.25-mg dose of Betesil applied to the painful joint every night before bedtime for 10 days. Pain and functional disability were assessed, by the Visual Analogue Scale (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scores. Redness was assessed by clinical inspection, and edema by the "fovea sign" method. C-reactive protein (CRP) was also measured; CRP can be used to cost-effectively monitor the pharmacological treatment efficacy and is increased during the acute-phase response, returning to physiological values after tissue recovery and functional restoration. All measurements were at baseline and at 10-day follow-up. At 10-day follow-up, a greater improvement in VAS and WOMAC pain and WOMAC stiffness and functional limitation scores from baseline was observed in patients treated with Betesil compared with diclofenac (all p < 0.01). At 10-day follow-up, improvement in redness, edema, and CRP levels from baseline was also greater in patients treated with Betesil compared with diclofenac (all p < 0.01). This study demonstrates the safety and efficacy of transdermal delivery of betamethasone valerate in patients affected by arthritis and osteoarthritis.
authors.affiliation: KWS BioTest, Marine View Office Park, Portishead, Somerset, BS20 7AW, UK. tommaso.iannitti@gmail.com.|Poliambulatorio del Secondo Parere, 41100, Modena, Italy. tommaso.iannitti@gmail.com.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Iannitti
authors.affiliation: National Institute for Health Research - Leeds Musculoskeletal Biomedical Research Unit (NIHR-LMBRU) and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), Wellcome Trust Brenner Building, St James's University Hospital, Beckett Street, Leeds, West Yorkshire, LS9 7TF, UK.
authors.forename: Michael F
authors.initials: MF
authors.lastname: McDermott
authors.affiliation: Poliambulatorio del Secondo Parere, 41100, Modena, Italy.|Department of General Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, 41100, Modena, Italy.
authors.forename: Carmen
authors.initials: C
authors.lastname: Laurino
authors.affiliation: Department of Medical and Surgical Sciences for Children and Adults, University of Modena and Reggio Emilia, 41100, Modena, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Malagoli
authors.affiliation: Poliambulatorio del Secondo Parere, 41100, Modena, Italy.|Department of General Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, 41100, Modena, Italy.
authors.forename: Beniamino
authors.initials: B
authors.lastname: Palmieri
mesh_terms: D000279:Administration, Cutaneous; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001168:Arthritis / Q000097:blood / Q000188:drug therapy*; D001624:Betamethasone Valerate / Q000008:administration & dosage* / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000032:analysis; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D004008:Diclofenac; D002097:C-Reactive Protein; D001624:Betamethasone Valerate
keywords: Arthritis; Betamethasone valerate; C-reactive protein; Functional disability; Osteoarthritis; Pain; Stiffness; Transdermal drug delivery