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THU0355 Efficacy and Safety of Adalimumab in Patients with Ankylosing Spondylitis and Total Spinal Ankylosis in Croatia: One Year Follow-Up
  1. F. Grubišić1,
  2. S. Grazio2,
  3. Ð. Babić-Naglić3,
  4. J. Morović-Vergles4,
  5. B. Anić5,
  6. T. Kehler6,
  7. S. Novak7,
  8. P. Perić3,
  9. M. Hanih8,
  10. A. Gudelj4,
  11. N. Ljubičić-Marković9
  1. 1Department of Rheumatology, Physical Medicine And Rehabilitation
  2. 2Deaprtment of Rheumatology, Physical Medicine And Rehabilitation, University Hospital Center Sestre Milosrdnice
  3. 3Department of Rheumatology and Rehabilitation, Clinical Hospital Center Zagreb
  4. 4Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University Hospital Dubrava
  5. 5Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Clinical Hospital Center Zagreb, Zagreb
  6. 6Rheumatology, Physical Medicine and Rehabilitation, Thalassotherapia Opatija, Opatija
  7. 7Rheumatology and Clinical Immunology, Department of Internal Medicine, Clinical Hospital Center Rijeka, Rijeka
  8. 8Department for rheumatic diseases, Physical Medicine and Rehabilitation, General Hospital ¨Dr Josip Benčević¨, Slavonski Brod
  9. 9Department of Physical Medicine and Rehabilitation, Vukovar General Hospital, Vukovar, Croatia


Background Patients with ankylosing spondylitis (AS) who develop total spinal ankylosis (TSA) experience more functional impairment and are at higher risk for serious complications (e.g. spinal fractures). They also might have more signs and symptoms of active disease (1)

Objectives To evaluate the efficacy and safety of adalimumab in patients with AS and TSA.

Primary endpoint. The ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at week 12 and 52.

Type of research. Multicenter, prospective.

Methods Nineteen patients (17 men, 2 women; mean age 49.1 ± 11.2 years) diagnosed with AS according to the 1987 modified NY criteria and TSA were recruited from the databases of eight rheumatology departments in Croatia. All patients had active disease (BASDAI ≥ 4) and treated with adalimumab (40mg/bi-weekly) (2). A structured questionnaire containing demographic and clinical data was used. Following variables were evaluated at week 12 and 52: function using BASFI, disease activity using BASDAI, patient’s and physician’s global assessment of disease activity, total back pain and fatigue, all of them measured on visual analogue scale (VAS). Both efficacy and safety results are summarised descriptively.

Results Mean disease duration was 20.2± 11.6 years. Compared to baseline measures, there was a significant improvement in BASFI and BASDAI at week 52: BASFI (6.9 ± 1.19 and 3.13 ± 1.54, respectively) and BASDAI (6.8 ± 1.03 and 2.28 ± 1.45, respectively). Significant improvement was also seen at baseline and week 52 in other observed variables: patient’s and physician’s global assessment, total back pain and fatigue. At month 3 ASAS20 was reached in 18/19 patients and at months 12 in 17/19 patients. Injection site erythema was reported in 2 patients only at first months of the treatment. No serious side effects were observed during 12-month treatment with adalimumab.

Conclusions In our 12-month study adalimumab treatment of patients with AS and TSA resulted in clinically significant improvement regarding function and disease activity. No serious adverse side effects were reported in our cohort.


  1. van der Heijde D, Pangan AL, Schiff MH, Braun J, Borofsky M, Torre J, Davis JC Jr, Wong RL, Kupper H, Collantes E. Adalimumab effectively reduces signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann Rheum Dis. 2008; 67(9): 1218–1221.

  2. Babić-Naglić D, Laktasić N, Jajić Z, Anić B, Morović-Vergles J, Curković B; Croatian Society for Rheumatology. Proposal of Croatian Society for Rheumatology for anti-TNF-alpha therapy in adult patients with spondyloarthritides. Reumatizam. 2007;54(1):20-30

Disclosure of Interest None Declared

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