Background Behcet's disease is a multisystemic chronic relapsing inflammatory disease, classified among the vasculitides. The clinical manifestations include mucocutaneous lesions, articular, ocular, vascular, gastrointestinal and/or central nervous system involvement. The aetiology of Behcet's disease is unknown. TNF-α may play an important role in the pathogenesis of the disease. Short term studies reported the efficacy of anti-TNFα therapy, particularly regarding ocular and mucocutaneous involvement in Behcet's.
Objectives The primary end point was to assess efficacy and safety of Adalimumab (ADA) in patients with active Behcet's arthritis not responding to one or more DMARDS. The secondary end point was to assess the impact of treatment on other disease manifestations.
Methods Eligible patients with active arthritis were enrolled in a 24 weeks single center prospective open-label study. Patients who relapsed within 12 weeks following ADA discontinuation could enter a 3 year extension study. The efficacy was assessed by 68 tender and 66 swollen joint count, patient visual analogue scale (VAS) for pain, physician overall disease activity VAS, health assessment questionnaire (HAQ), Behçet's Disease Current Activity Form (BDCAF), C reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Statistical methods: descriptive statistics, T test, Mann-Whitney U test.
Results Ten patients (6 females),age (mean, standard deviation – SD) 45 (8.4) years, with a disease duration of 11.6 (10) years, met the inclusion, exclusion criteria and were treated with subcutaneous ADA 40mg every 2 weeks for 24 weeks. The clinical manifestations included arthritis, oral and urogenital aphtae in all patients, erythema nodosum (3 patients) and other skin involvement (3 patients), uveitis (1 patient) and deep vein thrombosis (1 patient). Prior to ADA therapy they failed treatment with3.2 (1.3) different DMARDs. A statistically significant improvement was observed in swollen joint count (mean (SD) at baseline 4.6 (4.2) vs 0.4 (0.6) at 24 weeks, p=0.006), physician VAS (51.5 (18.5) vs 24.5 (16), p=0.002) and BDCAF (5.4 (1.6) vs 2.1 (1.4), p=0.001), but not in tender joint count (19 (18.7) vs 10.9 (12.6), p=0.14) or HAQ (1.76 (0.85) vs 1.59 (0.99), p=0.14). Resolution of oral and urogenital ulcers was achieved in all patients. Significant reduction of pain was reported by 40% of patients. No relapse of uveitis or other disease manifestations occurred during the study. The treatment was well tolerated: there were no serious adverse events; there were no injection related site reactions. Four infective episodes (2 cases of pneumonia and 2 of sinusitis), were treated ambulatory and did not require ADA withdrawal. The disease relapsed in 9 out of 10 patients, within 4–6 weeks following ADA interruption, 7 patients enrolled into the extension study.
Conclusions ADA treatment was well tolerated and achieved a significant improvement in arthritis and mucocutaneous manifestations in all study patients but only 40% reported significant pain reduction. A subset of patients with insufficient improvement in joint tenderness and generalized pain may require comprehensive pain management besides anti-inflammatory therapy.
Acknowledgement ABBVIE donated the study medication
Disclosure of Interest None declared