Meet Naidu, a 38-year-old patient living with the symptoms of advanced AS.1
'I’ve had back pain2,3 for over 10 years4, but it was only when I started having difficulty breathing that I was diagnosed with advanced AS’.
‘Despite taking NSAIDs for the last 6 years, my symptoms are worsening.1 Also, with AS I could develop uveitis5 that might lead to vision loss, which is terrifying’.
I live by myself and don’t know how I’d be able to function without help if my health deteriorates’.
Average diagnosis delay in AS is approximately 6 years (±5 years).3,* Among rheumatological diseases, the longest diagnosis delay is in AS.4
Note: This is a hypothetical case for representation purpose only.
Patients with advanced AS such as Naidu benefit from treatment with Enbrel®1-3,5
- No increased rates of uveitis observed with Enbrel®5
From SPINE, the first placebo-controlled trial to evaluate a TNFi – and the first to evaluate pulmonary function – in advanced AS.3,‡
Improvement in BASDAI for up to 24 Weeks2
P = 0.008. Enbrel® versus placebo at Week 12.3
No statistical analysis reported for the OLE period.
Adapted from Dougados M, et al. 2012.
Please consult the LPD for contraindications, warnings, precautions and other important safety information.
Please note: The examples described here are not of actual patients, but fictitious representations of scenarios for which Enbrel® (etanercept) could be considered.
*From a cross-sectional study that included 111 patients with AS who were interviewed/evaluated to determine the diagnosis delays experienced (defined as the gap between first spondiloarthropathic symptoms and correct diagnosis) as well as the possible reasons for the delays.4
†In patients with advanced AS from SPINE, a 12-week, randomised, double-blind, placebo-controlled study.3
‡In patients who completed the 12-week OLE of the SPINE study.2
Study design: Dougados M, et al. 2011; 2012.
SPINE was a European, multicentre, randomised, double-blind, placebo-controlled trial of 12 weeks duration,3 followed by a 12-week OLE study.1 Patients included in the double-blind study had a diagnosis of AS (modified NY criteria) and met at least 1 criterion that defined advanced/severe spinal ankylosis: (1) 2 intervertebral adjacent bridges and/or fusion at the lumbar spine; (2) 3 intervertebral adjacent bridges and/or fusion at the thoracic spine; (3) 2 intervertebral adjacent bridges and/or fusion at the cervical spine.2 Patients (n=82) were randomly assigned to receive either Enbrel® 50 mg QW or placebo.2 A total of 77 patients completed the 12 weeks of treatment (38 who received Enbrel® and 39 who received placebo) and entered the OLE study.2
The primary endpoint of the double-blind study was improvement in the BASDAI (normalised net incremental AUC) between baseline and Week 12.3 Other outcome measures included PGA, BASFI, BASMI and CRP level. Patient-evaluated endpoints included MCII and PASS from Weeks 2 to 12.3 At Weeks 0 and 12, pulmonary function tests were locally performed in accordance with the standards of the American Thoracic Society.2
Safety assessments included AEs, premature discontinuations and laboratory tests.2
§Clinical trials of Enbrel® in AS (4 placebo-controlled; 1 active-controlled; 3 open-label) were examined for reports of uveitis. Rates of uveitis with Enbrel® were lower than those with the placebo (in placebo-controlled trials) and similar to sulfasalazine in an active comparator trial.5
AE, adverse event; AS, ankylosing spondylitis; AUC, area under the curve; axSpA, axial spondyloarthritis; BASDAI, Bath AS Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath AS Metrology Index; CRP, C-reactive protein; MCII, minimum clinically important improvement; NSAID, non-steroidal anti-inflammatory drug; OLE, open-label extension; PGA, patient global assessment; QW, once a week; RCT, randomised control trial; SEM, standard error of the mean; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
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