Two years follow-up of golimumab treatment in refractory enteropathic spondyloarthritis patients with Crohn disease : A STROBE-compliant study

Abstract

Golimumab is a fully human monoclonal antibody against tumor necrosis factor (TNF) approved for the treatment of ulcerative colitis and not for Crohn disease (CD). Many CD patients experience primary, secondary failure, or intolerance to other TNF inhibitors (TNFi) approved in Italy for CD (adalimumab and infliximab). Spondyloarthritis (SpA) may be associated with CD (enteropathic, ESpA) in up to 50% of patients requiring a multidisciplinary and tailored approach. However, only few data from literature and no formal trials determined the efficacy and safety of golimumab in ESpA patients. We performed a case series on 12 patients affected by active CD and active ESpA were failure or intolerant to previous TNFi approved in Italy for both SpA and CD, infliximab and adalimumab. Golimumab was administered following rheumatologic dosage (subcutaneous 50 mg monthly; 100 mg monthly for patients ≥100 kg). Gastrointestinal and rheumatologic disease activity was evaluated with a follow-up of 2 years. A total of 9 patients were followed for 2 years of golimumab treatment. CD clinical activity ameliorated as shown by the reduction of Harvey–Bradshaw index and Crohn disease activity index (CDAI) at 12 and 24 months of treatment ( P = .03 and P = .04, respectively) associated with reduction of C-reactive protein at 12 and 24 months ( P = .04 for both comparisons) of treatment. SpA assessment revealed a significant reduction in tender joint count at 6 ( P = .03), 12 ( P = .03), and 24 months ( P = .007) of treatment. Swollen joint count, pain, SpA disease activity, and disability reduced in several patients during the follow-up. No adverse events were registered in the follow-up. We demonstrate good clinical efficacy and safety profile of both gastrointestinal and rheumatologic involvement. This may indicate promising therapeutic option for ESpA patients affected by CD, and non-responsive to other TNFi.