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Adalimumab provides long-lasting clinical improvement in refractory mucocutaneous Behçet’s disease without formation of antidrug antibodies

1, 2, 3, 4, 5, 6, 7, 8

  1. Department of Immunology and Department of Internal Medicine, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  2. Department of Immunology and Department of Internal Medicine, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  3. Allergy & Clin. Immunology, Immunomodulation & Tolerance Group, Natl Heart & Lung Inst., Inflammation Repair & Development, Imperial College, London, UK; Dept. of Pulmonology, STZ Centre of Excellence Asthma & COPD, Franciscus Group, Rotterdam, Netherland
  4. Department of Immunology and Department of Internal Medicine, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  5. Department of Immunology, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  6. Department of Immunology, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  7. Department of Immunology and Department of Internal Medicine, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands.
  8. Department of Immunology and Department of Internal Medicine, Section of Clinical Immunology, Erasmus University Medical Center Rotterdam, the Netherlands. j.vanlaar@erasmusmc.nl

CER11761 Submission on line
Full Papers

Rheumatology Article
Rheumatology Article

 

Abstract

OBJECTIVES:
The TNF-blocker adalimumab can be effective in Behçet’s disease (BD), a multisystem auto-inflammatory disorder. Unfortunately, the therapeutic efficacy of TNF-blockers can be hampered by the formation of anti-drug antibodies. We present an observational study of adalimumab in refractory BD with measurement of anti-drug antibodies.
METHODS:
The effect of fortnightly 40mg adalimumab in nine patients with therapy refractory mucocutaneous, non-ocular or organ threatening BD was studied up to 60 months. Primary endpoint was a decrease in disease activity, measured by the BD Current Activity Form (BDCAF) within 6 months. Secondary endpoints included serum cytokines and the long-term formation of anti-adalimumab antibodies.
RESULTS:
BDCAF improved significantly in all nine patients from 5.4 (SD=1.4) to 2.4 (SD=1.4) (p=0.007) within one month up to 6 months and after prolonged follow up of 5 years. All patients could either taper or stop concomitant therapy. Symptoms of mucocutaneous lesions, erythema nodosum and joint involvement decreased or disappeared. Serum TNF-alpha levels were elevates in five patients and decreased upon treatment (p=0.017). Adalimumab was save and none of the patients experienced therapy failure or antibodies against adalimumab.
CONCLUSIONS:
We present an observational study on patients with BD treated with adalimumab and provide a basis for long-term use in refractory mucocutaneous BD. These findings show that adalimumab can safely be administered yielding sustainable clinical effects in refractory BD patients with mucocutaneous disease without formation of anti-adalimumab antibodies, even after long follow up.

PMID: 30873952 [PubMed]

Received: 21/09/2018 - Accepted : 08/02/2019 - In Press: 11/03/2019