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Information on how to access Enbrel® (etanercept) prescribing information and adverse event reporting can be found at the bottom of the page.

Ankylosing spondylitis

Indication

Enbrel is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.1

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients1
  • Sepsis or risk of sepsis1
  • Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections1

AS dosing

The recommended dose of Enbrel in adults is 25 mg administered twice weekly, or 50 mg administered once weekly.1

Data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.1

Clinical efficacy

The efficacy of Enbrel in AS was assessed in a randomised, double-blind study comparing twice-weekly administration of 25 mg Enbrel with placebo. The study enrolled 277 patients between 18–70 years of age with active AS, defined as VAS scores of ≥ 30 for average duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the BASFI. Patients receiving DMARDs, NSAIDs, or corticosteroids could continue them on stable doses. Doses of 25 mg of Enbrel or placebo were administered SC twice a week for 6 months in 138 patients.1

The primary measure of efficacy (ASAS 20) was a ≥ 20% improvement in at least 3 of the 4 ASAS domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain. ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.1

Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.1

Percentage of patients with improvements in ASAS 20, 50 and 701

Adapted from Enbrel SmPC.
*p<0.001, Enbrel vs. placebo
†p=0.002, Enbrel vs. placebo

Among patients with AS who received Enbrel, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy. Responses were similar in patients who were or were not receiving concomitant therapies at baseline.1

Summary of the safety profile

The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.1

Serious adverse reactions have also been reported for Enbrel. TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body's defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with Enbrel. Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).1

Before prescribing Enbrel refer to the full Summary of Product Characteristics.

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Enbrel dosing and administration

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AS=ankylosing spondylitis; ASAS=Assessment in Ankylosing Spondylitis; BASFI=Bath Ankylosing Spondylitis Functional Index; DMARD=disease-modifying anti-rheumatic drug; NSAID=non-steroidal anti-inflammatory drug; SC=subcutaneous; TNF=tumour necrosis factor; VAS=visual analogue scale.

References:
  1. Enbrel (etanercept) SmPC. 50 mg solution for injection in pre-filled pen.
PP-ENB-GBR-0981. March 2021

Learn about the licensed indication of Enbrel in patients with plaque psoriasis.

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PP-PFE-GBR-2688. December 2020

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