Certolizumab Pegol treatment in Behcet's disease with different organ involvement: A multicenter retrospective observational study.

OBJECTIVES: The purpose of the present study was to describe our experience with the recombinant Fab' antibody fragment against TNF-alpha Certolizumab Pegol (CZP) in patients with Behcet's disease (BD) refractory to standardized therapies and previous biologic agents. METHODS: Retrieved data including demographic characteristics, clinical manifestations, and previous treatments were collected in three different specialized Rheumatologic Units in Italy. In order to evaluate disease activity, the BD current activity form (BDCAF) has been used before starting CZP therapy and at each visit during treatment. RESULTS: Thirteen BD patients (mean age 42.6 +/- 8.8 years) with a disease duration of 8.80 +/- 6.9 years, underwent CZP treatment for 6.92 +/- 3.52 months. Six patients (46.15%) experienced a worsening of symptoms after 4.16 +/- 1.21 months, whereas a satisfactory response was achieved in seven patients (53.84%) who were still on CZP therapy at the last follow-up visit (after 9.28 +/- 3.03 months of treatment). The mean decrease of BDCAF between the first and last visit was 0.308 +/- 1.84 without reaching significant difference (mean 8.3 +/- 1.3 and 8 +/- 2.08, respectively; p= .51). During the whole study period, CZP was well tolerated in all patients except one who developed a generalized cutaneous reaction after the third administration. CONCLUSIONS: These results suggest that despite an improvement of clinical manifestations has been observed in more than half of the patients, it is not possible to draw firm conclusions about the effectiveness of CZP in BD and further studies with larger cohorts of patients are warranted. Whether the increase of CZP dosage may ensure a better clinical response remains an unsolved issue that needs to be considered.