Comparative study of corticosteroid monotherapy, and TNF inhibitors with or without corticosteroid in patients with refractory entero-Behcet’s disease

Abstract

Background Tumor necrosis factor (TNF) inhibitors (TNF-i) are effective in the treatment of entero-Behcet’s disease (BD). However, there is no objective tool for assessment of disease activity in entero-BD; therefore, it is not easy to evaluate treatment effectiveness in the clinical setting. In addition, because corticosteroid (CS) is considered for standard therapy, the effectiveness of TNF-i without CS has not been well examined. In this retrospective study, the effectiveness of CS without TNF-i and the effectiveness of TNF-i with or without CS therapy were investigated and compared. Methods This study included 71 patients with entero-BD who were followed up for 1 year (CS without TNF-i group: n = 22; TNF-i group: n = 49 [with CS: n = 20, without CS: n = 29]). All patients had active ulcerative lesions. The primary endpoint was the ulcer cure rate evaluated by lower gastrointestinal endoscopy. Secondary endpoints were ulcer improvement rate, disease activity improvement based on the quantitative disease activity index for intestinal Behcet’s disease (DAIBD), and CS-sparing effect. Results Ulcer cure rates were 13.6% in the CS without TNF-i group, 60.0% in the TNF-i with CS group, and 44.8% in the TNF-i without CS group. Ulcer improvement rates were 27.2% in the CS without TNF-i group, 60.0% in the TNF-i with CS group, and 51.7% in the TNF-i without CS group. The multivariate analysis revealed that TNF-i was an independent predictive factor for cure of the ulcerative lesions. The DAIBD and concomitant CS dose were significantly decreased in both the CS without TNF-i group (DAIBD 85.2 → 40.5, CS 32.3 → 18.7 mg/day) and the TNF-i group (DAIBD 64.7 → 21.1. CS 18.7 → 3.88 mg/day). The ulcer cure and improvement rates were significantly higher in the TNF-i group. In addition, the proportion of concomitant CS dose less than 7.5 mg was significantly higher in the TNF-i group (CS without TNF-i group 18.2% vs. TNF-i group 85%, P < 0.01). There were no statistically significant differences between the TNF-i with CS group and the TNF-i without CS group in any of the endpoints. Conclusions This study demonstrated that compared to CS alone, TNF-i improve disease activity and possess a higher ulcer healing effect and CS tapering effect with or without concomitant CS.

C-reactive protein is associated with postoperative outcomes in patients with intestinal Behçet’s disease

“…The postoperative use of azathioprine can reduce clinical relapse [ 34 ]. Anti-TNF agents can also improve the clinical course of intestinal BD compared with the use of corticosteroids [ 25 , 35 ]. Furthermore, emergent surgery and elevation of postoperative erythrocyte sedimentation rate were prognostic factors for re-operation within 6 months in intestinal BD [ 36 ].…”

Behcet’s Disease: An In-Depth Review about Pathogenesis, Gastrointestinal Manifestations, and Management

“…A retrospective cohort study conducted by Sugimura et al [78] showed that TNF-inhibitor agents induced both clinical and endoscopic remission in patients with intestinal BD. A 2019 study conducted by Miyagawa et al [79] also found that when corticosteroids are used in combination with TNFinhibitor agents that there was a significantly increased ulcer healing rate on endoscopy which could be another option prior to moving onto 3rd line agents.…”

“…Currently, endpoints for treatment are not well established in regard to whether the goal should be to aim for ulcer healing on endoscopy or simply clinical remission. Studies have been conducted that show some correlation (albeit weak correlation) between endoscopic ulcer healing and clinical improvement [79]. Kinoshita et al [76] also proposed an endoscopic scoring system to attempt to predict postsurgical relapse in patients who had required surgery for their disease and found that there was a relationship between patients with endoscopic relapse and clinical relapse.…”

Behҫet’s Disease, and the Role of TNF-α and TNF-α Blockers

“…All observational studies scored a low risk of bias, with the quality assessment in Miyagawa et al [59] scoring 7/9 and the other studies scoring 8/9. It should be noticed that the number of patients included is not taken into account in the quality assessment.…”

“…Miyagawa et al [59] compared the effectiveness of anti-TNF-α treatment with corticosteroids. Next to this, the additive value of corticosteroids to anti-TNF-α treatment was studied.…”