Two years follow-up of golimumab treatment in refractory enteropathic spondyloarthritis patients with Crohn disease

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.

Inflammatory bowel disease: focus on enteropathic arthritis and therapy

“…This study suggest that golimumab may be an alternative therapeutic option for enteropathic spondyloarthropathy in CD patients who are not responsive to other TNF inhibitors. [ 64 ] Certolizumab is a Fab fragment of a recombinant, humanized anti-TNF monoclonal antibody. Studies have shown effectiveness in the treatment of AS, PsA, and CD.…”

Long-term effectiveness and drug survival of golimumab in patients affected by psoriatic arthritis with cutaneous involvement

“…In our cohort, we did not observe gender differences in the efficacy of GLM, since gender was not a relevant factor in patient outcomes. The high prevalence of IBD in our cohort is due to the early referral in the combined gastro-rheuma outpatient clinic by gastroenterologists from the involved hospitals [ 33 , 34 ]. Thyroid dysfunction may be associated with the worst clinical outcome in several inflammatory conditions and in PsA [ 26 , 35 , 36 ].…”

Reasons and Factors Contributing to Chinese Patients’ Preference for Ustekinumab in Crohn’s Disease: A Multicenter Cross-Sectional Study

“…Male and female patients enrolled in the study had a diagnosis established by a combination of clinical symptoms, endoscopic examination, pathologic examination, and the absence of alternative diagnoses ( Lichtenstein et al, 2018 ). CD activity was classified based on the Crohn’s disease activity index ( Conigliaro et al, 2021 ). The studies involving human participants were reviewed and approved by the China Ethics Committee of Registering Clinical Trials.…”