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Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis
  1. Désirée van der Heijde (publications{at}jkmed.com)
  1. Leiden University Medical Center, Netherlands
    1. Aileen L. Pangan (aileen.pangan{at}abbott.com)
    1. Abbott Laboratories, United States
      1. Michael H. Schiff (mschiff{at}denverarthritisclinic.com)
      1. Denver Arthritis Clinic Research Unit, United States
        1. Jürgen Braun (j.braun{at}rheumazentrum-ruhrgebiet.de)
        1. Ruhr University Bochum, Germany
          1. Michael Borofsky (mborofsky{at}crcreading.com)
          1. Arthritis and Osteoporosis Center, Clinical Research Center of Reading, United States
            1. Juan Torre (jctorre{at}telecable.es)
            1. Hospital Monte Naranco, Spain
              1. John C. Davis, Jr (jdavis{at}medicine.ucsf.edu)
              1. University of California, United States
                1. Robert L. Wong (robert.wong{at}abbott.com)
                1. Abbott Laboratories, United States
                  1. Hartmut Kupper (hartmut.kupper{at}abbott.com)
                  1. Abbott GmbH & Co. KG, Germany
                    1. Eduardo Collantes (eduardo.collantes.sspa{at}juntadeandalucia.es)
                    1. Hospital Universitario Reina Sofia, Spain

                      Abstract

                      Objective: To evaluate the long-term safety and efficacy of adalimumab in patients with ankylosing spondylitis (AS) with total spinal ankylosis (TSA).

                      Methods: Patients (N=315) with active AS were randomised in a 2:1 ratio to receive adalimumab 40 mg every other week or placebo for 24 weeks followed by open-label adalimumab for up to 5 years. Two-year efficacy and safety data for 11 patients with investigator-defined TSA were evaluated. The primary endpoint was the ASsessment in AS International Working Group 20% improvement (ASAS20) at Week 12. On or after Week 12, ASAS20 nonresponders could switch to open-label adalimumab. Other efficacy measurements included ASAS40, ASAS 5/6, ASAS partial remission, and 50% improvement in the Bath AS Disease Activity Index (BASDAI 50).

                      Results: Six of 11 TSA patients were randomised to adalimumab and five, to placebo. At Week 12, 50% of the adalimumab-treated patients achieved an ASAS20 response and 33% achieved an ASAS40, ASAS 5/6, and BASDAI 50. No placebo-treated patients achieved any response criteria at Week 12. Four placebo- and two adalimumab-treated patients switched to open-label adalimumab before Week 24. After 1 year of adalimumab treatment, eight of 11 patients achieved an ASAS20 response. After 2 years, six of the remaining eight patients with TSA reported an ASAS20 response. There were no serious adverse events or adverse event–related study discontinuations.

                      Conclusion: In patients with TSA, adalimumab treatment resulted in rapid and clinically significant improvement in the signs and symptoms of active disease. Adalimumab effectiveness and safety were sustained for at least 2 years.

                      • adalimumab
                      • ankylosing spondylitis
                      • total spinal ankylosis
                      • tumour necrosis factor antagonist

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