AS Patients With Heel Enthesitis

Meet Krishna, a 51-year-old AS patient¹ with heel enthesitis.²

AS patients with heel enthesitis such as Krishna benefit from treatment with Enbrel^®2,4

• Significant and clinically relevant improvement in refractory heel enthesitis^2,†

• Significantly greater improvements versus placebo in^2,†:

         - Heel pain

         - Lower-limb function

         - Patient-reported symptoms

• Enbrel is well tolerated across all its indications^1,5-28

• axSpA: Predictable and manageable safety profile^1,5,6

From HEEL, the first randomised, double-blind, placebo-controlled trial of a TNFi in 24 patients with refractory heel enthesitis in SpA.^2,†

PGA of HEEL Enthesopathy Activity: Change From Baseline²

Adapted from Dougados M, et al. 2010.

Other Measures: Change From Baseline to Week 12²

Adapted from Dougados M, et al. 2010.

• Significantly greater improvements in heel pain at Week 8 with Enbrel^® versus placebo: −36.1 ± 24.0 versus −10.5 ± 24.0, respectively (P = 0.013)²
   

• No significant between-group differences in MRI findings²

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 (N=118) that evaluated the frequency and severity of enthesitis in SpA and also assessed the correlation of enthesitis with clinical, laboratory and QoL parameters.^3
†From HEEL, a 12-week, randomised, double-blind, placebo-controlled study that compared Enbrel^® 50 mg QW versus placebo in 24 patients with SpA and refractory, MRI-positive heel enthesitis. Mean (±SD) normalised net incremental AUC for PGA of disease activity over 12 weeks was significantly greater with Enbrel^® versus placebo: −28.5 ± 18.0 versus −11.1 ± 18.0, respectively; P = 0.029.² 

Study design: The primary efficacy endpoint of HEEL was the normalised net incremental AUC between randomisation and Week 12 for PGA of heel enthesopathy activity (measured on a 100-mm VAS). Other endpoints included change from baseline in PGA of heel enthesopathy activity, heel pain (measured on a 100-mm VAS), WOMAC function subscale chosen as a measure of physical function in the lower limbs (0-100 normalised score, with 100 representing greatest functional impairment) and 2 endpoints evaluated by the patient: the patient-reported MCII (which defines whether observed difference [less pain] from baseline constitutes a trivial or an important improvement according to the patient) and the PASS. Efficacy was also assessed by the response at Week 12, defined as ≥50% improvement (decrease) from baseline in the PGA, and improvement in enthesitis as measured by MRI. Safety and tolerability were evaluated by assessing the incidence and severity of AEs.²

AS, ankylosing spondylitis; AUC, area under the curve; axSpA, axial spondyloarthritis; HEEL, A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial; MCII, minimum clinically important improvement; MRI, magnetic resonance imaging; NSAID, non-steroidal anti-inflammatory drug; PASS, patient acceptable symptom state; PGA, patient global assessment; QW, once a week; SD, standard deviation; SEM, standard error of the mean; SmPC, summary of product characteristics; SpA, spondyloarthritis; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities Arthritis Index.

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