Meet Shiva, a 44-year-old patient dealing with the functional challenges of AS.1,2
Example
‘Every single day is a struggle and I feel so useless. I’m not even able to do basic household tasks or show my son how to tie his shoe laces’.2
‘I can’t afford to take any more time off work, and I’m worried all the NSAIDs I’m being prescribed are going to have a negative impact on me in the future’.3
The rate of severe functional disability was 32% higher in men with AS versus men with RA.2,*
Note: This is a hypothetical case for representation purpose only.
AS patients with functional limitations such as Shiva benefit from treatment with Enbrel®3-5
From an open-label, multicentre, Phase 4 study in 59 patients with AS treated with Enbrel® 25 mg BIW.4,†
Reduction in Functional Impairment Over 5 Years4
Adapted from Martín-Mola E, et al. 2010.
Improvement in Spinal Mobility Over 5 Years4
Adapted from Martín-Mola E, et al. 2010.
Adapted from Martín-Mola E, et al. 2010.
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.
*Data were analysed from the German rheumatological database of 52,444 patients with RA and 8776 patients with AS. Age- and sex-matched groups of patients were compared for functional disability, pain, global assessment of health status, education level and employment status. Across all evaluated age groups, men with AS were rated more disabled than men with RA (e.g. 41-50 years: 38.5% vs. 29.1%, respectively [P<0.0025]).2
†From an open-label, multicentre, Phase 4, 3-year extension study in 59 patients with AS who completed a 3-month RCT followed by a 2-year open-label study. Improvements in physical function (mean BASFI score) and spinal mobility (mean modified Schober’s test score) were sustained from Week 108 through Week 264.4
Study design: Martin-Mola E, et al. 2010.
A 12-week randomised, placebo-controlled study (N=84) of Enbrel® was followed by a 96-week open-label study (n=81); 59 subjects subsequently enrolled in a second open-label trial and continued Enbrel® 25 mg BIW for an additional 156 weeks (total duration: 264 weeks, original Enbrel® group; 252 weeks, original placebo group). The objective of the trial was to assess the long-term safety and clinical efficacy of Enbrel® for up to 5 years in patients with AS.4
Efficacy assessments included improvements in AS (as defined by the ASAS) and the individual core components of the ASAS criteria, including BASFI, subject global assessment of disease activity, back pain (total and nocturnal) and morning stiffness. Other variables assessed were BASDAI, PGAs of disease, spinal mobility as measured by the modified Schober’s test, chest expansion scores, occiput-to-wall distance, number of painful and swollen joints, CRP levels and percentage of subjects achieving partial remission.4
‡From a Phase 4, open-label, multicentre (UK, Scandinavia) extension study in 84 patients with AS who completed ASCEND, a 16-week,randomised, controlled, active-comparator study. QoL increased for all subjects, with a mean of 0.3 as measured by EQ-5D. Mean number of sick days significantly decreased from 37.4 to 15.1 (P = 0.008). Mean number of work days significantly increased from 226 to 241 (P = 0.144).5
§From SPARSE, an 8-week, double-blind, placebo-controlled study in 90 patients with active axSpA (57% of whom had radiographic sacroiliitis) despite optimal NSAID intake. Mean change (SE) from baseline to Week 8 in ASAS-NSAID score: 63.9 (6.1) with Enbrel® versus 36.6 (5.9) with placebo (P = 0.002). ASAS-NSAID score of <10: 46.2% with Enbrel® versus 16.7% with placebo (P = 0.008). ASAS-NSAID score of 0: 41.0% with Enbrel® versus 14.3% with placebo (P = 0.013).3
ASCEND, Ankylosing Spondylitis Study Comparing ENbrel and Sulfasalazine Dosed Weekly; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society; ASAS-NSAID, Assessment of SpondyloArthritis international Society - nonsteroidal anti-inflammatory drug use; axSpA, axial spondyloarthritis; BASFI, Bath Ankylosing Spondylitis Functional Index; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BIW, twice a week; CRP, C-reactive protein; EQ-5D, EuroQoL Group Score; LOCF, last observation carried forward; NSAID, non-steroidal anti-inflammatory drug; PASS, patient acceptable symptom state; PGA, physician global assessment; QoL, quality of life; RA, rheumatoid arthritis; RCT, randomised controlled trial; SE, standard error; SmPC, summary of product characteristics; SPARSE, A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis; UK, United Kingdom.
References:
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