Frane Grubišić1, Đurđica Babić Naglić2, Porin Perić2, Jadranka Morović-Vergles3, Branimir Anić4, Tatjana Kehler5, Srđan Novak6, Marino Hanih7, Ana Gudelj Gračanin3, Nikolina Ljubičić Marković8, Simeon Grazio9. 1. Department of Rheumatology, Physical Medicine and Rehabilitation, School of Medicine, University of Zagreb, Referral Center for Spondyloarthropathis Ministry of Health of the Republic of Croatia, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia. franegrubisic@gmail.com. 2. Department of Rheumatology and Rehabilitation, School of Medicine, University of Zagreb, Clinical Hospital Center Zagreb, Zagreb, Croatia. 3. Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University Hospital Center Dubrava, Zagreb, Croatia. 4. Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Clinical Hospital Center Zagreb, Zagreb, Croatia. 5. Rheumatology, Physical Medicine and Rehabilitation, Thalassotherapia Opatija, Opatija, Croatia. 6. Rheumatology and Clinical Immunology, Department of Internal Medicine, Clinical Hospital Center Rijeka, Rijeka, Croatia. 7. Department for Rheumatic Diseases, Physical Medicine and Rehabilitation, General Hospital "Dr. Josip Benčević", Slavonski Brod, Croatia. 8. Polyclinic for Rheumatic Diseases, Physical Medicine and Rehabilitation "Dr. Drago Ćop", Zagreb, Croatia. 9. Department of Rheumatology, Physical Medicine and Rehabilitation, School of Medicine, University of Zagreb, Referral Center for Spondyloarthropathis Ministry of Health of the Republic of Croatia, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.
Abstract
OBJECTIVE: To evaluate the 12-month efficacy and safety profile of adalimumab and etanercept in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA). TYPE OF STUDY DESIGN: Case-series follow-up study. DESIGN: Twenty-eight patients (26 men and 2 women) with active AS (BASDAI > 4) and TSA were treated as follows: 19 patients receiving adalimumab and 9 patients receiving etanercept. Twelve-month data related to the efficacy and safety of these two TNF-alpha inhibitors were evaluated. The primary endpoint was ASAS 20 (the ASsessment in AS International Working Group criteria for 20% improvement) at weeks 12 and 52. Other measures that were evaluated were function (BASFI), disease activity (BASDAI), patient's and physician's global disease assessment on visual analogue scale (VAS) and C-reactive protein. RESULTS: In both adalimumab and etanercept groups, there was a significant improvement in all observed variables (baseline compared to weeks 12 and 52). This improvement was sustained for the whole follow-up period. In the adalimumab group, at week 12, ASAS 20 was achieved in 18/19 patients and at week 52 in 17/19 patients. In the etanercept group, at week 12 ASAS 20 was achieved in all patients and at week 52 in 6/9 patients. CONCLUSION: In patients with active AS and TSA, adalimumab and etanercept treatment showed significant improvement in function and disease activity. No serious side effects or adverse effects were observed in our cohort. Key Points • TNF-alpha inhibitors can be effective treatment options for patients with AS and having total spinal ankylosis. • Patients with advanced AS should not be disregarded as good candidates for treatment with biologic disease-modifying antirheumatic drugs.
OBJECTIVE: To evaluate the 12-month efficacy and safety profile of adalimumab and etanercept in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA). TYPE OF STUDY DESIGN: Case-series follow-up study. DESIGN: Twenty-eight patients (26 men and 2 women) with active AS (BASDAI > 4) and TSA were treated as follows: 19 patients receiving adalimumab and 9 patients receiving etanercept. Twelve-month data related to the efficacy and safety of these two TNF-alpha inhibitors were evaluated. The primary endpoint was ASAS 20 (the ASsessment in AS International Working Group criteria for 20% improvement) at weeks 12 and 52. Other measures that were evaluated were function (BASFI), disease activity (BASDAI), patient's and physician's global disease assessment on visual analogue scale (VAS) and C-reactive protein. RESULTS: In both adalimumab and etanercept groups, there was a significant improvement in all observed variables (baseline compared to weeks 12 and 52). This improvement was sustained for the whole follow-up period. In the adalimumab group, at week 12, ASAS 20 was achieved in 18/19 patients and at week 52 in 17/19 patients. In the etanercept group, at week 12 ASAS 20 was achieved in all patients and at week 52 in 6/9 patients. CONCLUSION: In patients with active AS and TSA, adalimumab and etanercept treatment showed significant improvement in function and disease activity. No serious side effects or adverse effects were observed in our cohort. Key Points • TNF-alpha inhibitors can be effective treatment options for patients with AS and having total spinal ankylosis. • Patients with advanced AS should not be disregarded as good candidates for treatment with biologic disease-modifying antirheumatic drugs.
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