_{MTX-IR Patient}

Meet Anjali, a 55-year-old patient whose active lifestyle is limited by her MTX-IR RA.^1-3

MTX-IR RA patients such as Anjali benefit from the flexibility of Enbrel^® + MTX treatment^1,4-7

• Clinical and radiographic benefits achieved with Enbrel^® alone or in combination with MTX^4-6
  • Similar substantial improvements in disease activity and symptoms^4,5,*
  • Numerically similar inhibition of radiographic progression up to 24 months^6,†
• Clinical, functional and QoL benefits achieved with Enbrel^® + MTX appear independent of MTX dosage^7,‡
• Enbrel^® is well tolerated across all its indications^1,8-31
  • RA: Low rates of discontinuation due to AEs for up to 12 years^8-12
• From CAMEO, an open-label, non-inferiority trial of 258 MTX-IR patients over 24 months.^6,†

Radiographic Progression Over 24 Months⁶

Adapted from Keystone EC, et al. 2016.

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 ADORE, a 16-week, randomised, open-label study that evaluated 315 patients with MTX-IR RA treated with Enbrel^® monotherapy or Enbrel^® plus MTX.⁴ Substantial improvements in disease activity were achieved in both treatment arms.⁴ Similar improvements were also observed across a range of PROs including disability, pain, general health and morning stiffness.^5
†From CAMEO, an open-label, non-inferiority trial of 258 patients with MTX-IR RA.⁶

Study design: Keystone EC, et al. 2016.

The CAMEO study was a Phase 4, multicentre, open-label, randomised, non-inferiority trial conducted at 27 sites in Canada. A total of 258 active RA patients with an inadequate response to MTX with or without other DMARDs who had access to Enbrel^® under usual care were initially treated with Enbrel^® 50 mg weekly plus steady-state MTX (minimum dose 15 mg/week) for 6 months. Patients who continued in the study were then randomised to continue Enbrel^® 50 mg weekly plus MTX (dose adjustments were allowed for MTX post randomisation per the clinician’s standard of care) (n=107) or discontinue MTX and receive Enbrel^® monotherapy (n=98) for an additional 18 months.⁶
The primary endpoint was the difference between the treatment groups in the change in DAS28-ESR from 6-month randomisation to 12 months. Radiographic outcomes (X-rays of the hands and feet) were assessed at baseline and at 12 and 24 months or at the time of discontinuation. mTSS, JSN and erosion scores were determined. Rates of radiographic progression (mTSS, JSN and erosion scores) were calculated using each patient’s duration from baseline to last X-ray.⁶
At Month 12, the non-inferiority of Enbrel^® monotherapy to combination therapy was not demonstrated. However, most patients in both treatment arms (60.6% on Enbrel^®, 64.4% on Enbrel^® + MTX) had no change in mTSS from baseline to Month 24.⁶

^‡From a post hoc analysis of 2 randomised clinical trials (TEMPO and COMET). Patients in the Enbrel^® plus MTX combination treatment arms of both trials were pooled and stratified at 24 months by weekly MTX dosage (low [<10.0 mg], medium [10.0-17.5 mg], high [>17.5 mg]). Treatment
responses were consistently high across the MTX dosage groups, with very similar rates of DAS28 LDA/remission and ACR20/50/70. Improvements in DAS28, HAQ-DI and EQ-5D VAS were also not dependent on the MTX dosage.⁷

ACR, American College of Rheumatology; ADORE, Add Enbrel or Replace Methotrexate; AE, adverse event; AS, ankylosing spondylitis; CAMEO, Canadian Methotrexate and Etanercept Outcome; COMET, COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis; DAS28, Disease Activity Score-28 joint count; DAS28-ESR, Disease Activity Score-28 joint count-erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; EQ-5D VAS, EuroQol 5-dimensions visual analogue scale; HAQ-DI, Health Assessment Questionnaire Disability Index; JIA, juvenile idiopathic arthritis; JSN, joint space narrowing; LDA, low disease activity; mTSS, modified total Sharp score; MTX, methotrexate; MTX-IR, methotrexate-inadequate responder; PRO, patient-reported outcome; PsA, psoriatic arthritis; PsO, psoriasis; QoL, quality of life; RA, rheumatoid arthritis; SD, standard deviation;  TEMPO, Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes.

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