Further Product Information

AUTHORS:

Stephanie Hennigan, Christoph Ackermann, Arthur Kavanaugh, Center for Innovative Therapy, Division of Rheumatology, Allergy and Immunology, University of California, La Jolla, California, USA

ABSTRACT

Introduction: Ankylosing spondylitis (AS) is an idiopathic chronic inflammatory disease that has prominent effects on the spine and peripheral joints. In addition, extraarticular manifestations such as enthesitis and acute anterior uveitis may be clinically important. In recent years, the therapy of AS has changed, largely due to the introduction of inhibitors of the proinflammatory cytokine tumor necrosis factor (TNF). Adalimumab, a human monoclonal antibody specifically for TNF, is the most recent of the TNF blocking agents that have been approved for the treatment of active, nonsteroidal antiinflammatory drug (NSAID)-refractory patients with AS.

Aims: To evaluate the evidence for the therapeutic value of adalimumab in ankylosing spondylitis.

Evidence review: There is clear evidence that adalimumab, administered 40 mg subcutaneously every 2 weeks, substantially improves the signs and symptoms of NSAID-refractory, active AS when compared with placebo treatment. There is ample evidence that adalimumab causes significant improvements in physical health status and overall AS-specific, health-related quality of life and physical functioning, which consequently leads to better work productivity. There is substantial evidence that adalimumab improves spinal and sacroiliac joint inflammation in AS patients. Initial results from clinical trials suggest that there is no increased risk of serious infections or malignancies in adalimumab-treated patients with AS. The most common adverse events were injection-site reactions. Limited economic evidence suggests that adalimumab 40 mg may be cost effective when used according to current valid treatment guidelines.

Place in therapy: Adalimumab is an effective treatment for patients with active AS.

ABOUT THE JOURNAL Core Evidence ISSN: 1555-1741 Core Evidence is the first international peer-reviewed journal to rigorously evaluate the evidence for rational drug selection based on outcomes central to informed medical decision making, with the goal of improved quality of care Core Evidence is unique because it: Focuses on clinical outcomes evidence Reviews the emerging evidence at key stages of drug development and evaluates how this may affect a drug’s place in therapy Conducts a rigorous review of the evidence based on: Relevance: formulary guideline requirements provide the structure Validity: evidence-based medicine techniques evaluate the evidence Credibility: input from international experts weights the evidence according to clinical relevance