In moderate to severe RA
Help improve physical function

  • In Moderately to Severely Active RA
  • In Moderate to Severe Early RA

Rapid and sustained improvements in HAQ score at Week 2 and out to Year 31

Reductions in HAQ score in the TEMPO study

LOCF=last observation carried forward.

  • TEMPO was a 3-year study that evaluated 682 patients with moderately to severely active RA (mean disease duration: 7 years) who had an inadequate response to at least 1 DMARD, excluding MTX1,2
  • Mean HAQ score at baseline, Week 2 and Year 3 were 1.7, 1.5, and 1.1 in the MTX arm and 1.8, 1.3, and 0.8 in the ENBREL + MTX arm, respectively1
  • Assessments were conducted as frequently as every 2 weeks.1 See study design for additional information
Additional Data1:
  • Reductions in HAQ score in the ENBREL monotherapy arm (n=223) were -19% at Week 2, -38% at Week 24, -40% at Year 1, -39% at Year 2, and -38% at Year 3
  • In the ENBREL + MTX arm, 16% of patients achieved HAQ ≤0.5 at Week 2 and 48% at Year 3. In the MTX arm, 11% of patients achieved HAQ ≤0.5 at Week 2 and 33% at Year 3

Study Design

THE TEMPO STUDY1-3:

  • Multicenter, double-blind, European, Australian, and Israeli study of 682 patients with moderately to severely active RA (mean disease duration: 7 years) who had an inadequate response to at least 1 prior DMARD but were not refractory to MTX1,2
  • Patients were randomized to receive MTX monotherapy rapidly escalated to 20 mg/week after 8 weeks (n=228), twice-weekly ENBREL 25 mg as monotherapy (n=223), or twice-weekly ENBREL 25 mg in combination with MTX (n=231)2
  • Use of concomitant corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) was permitted2
  • The primary clinical endpoint was the area under the curve (AUC) of the ACR numeric score at 24 weeks2
  • The primary radiographic endpoint was the change from baseline in TSS at 12 months2
  • Pain, morning stiffness, CRP, HAQ, and complete joint count were evaluated at Weeks 0, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 60, 68, 76, 88, 100, 112, 120, 128, 140, and 1523

Improvements in HAQ scores by week 12 and out to year 21

Reductions in HAQ score in the COMET study Year 2 population

LOCF=last observation carried forward.

  • COMET was a 2-year, 2-part study that evaluated 542 patients with moderately to severely active early RA (mean disease duration: 9 months).2,3 See the study design for information about the Year 1 and Year 2 study populations
  • Mean HAQ score at baseline was 1.65 in the MTX arm (n=94) and 1.76 in the ENBREL + MTX arm (n=108). At Year 2, mean HAQ score was 0.79 in the MTX arm and 0.58 in the ENBREL + MTX arm1
  • See study design for additional information
Additional Data:
  • In Year 1 of the COMET study, the mean reductions in HAQ score in the ENBREL + MTX arm (n=256) were -50% at Week 12, -56% at Week 24, -60% at Week 36, and -61% at Year 1 (P<0.001)3
  • In the MTX arm (n=241) mean reductions in HAQ were -32% at Week 12, -41% at Week 24,
    -45% at Week 36, and -44% at Year 1 (P<0.001)3
  • In the MTX → ENBREL + MTX arm, reductions in HAQ score were -35%, -46%, -54%, and -62% at Week 12, Week 24, Year 1, and Year 2, respectively.1 In the ENBREL + MTX → ENBREL arm, reductions were -52%, -60%, -63%, and -60% at the same time points1

Study Design

THE COMET STUDY

YEAR 1

  • 24-month, randomized, double-blind, 2-period study of 542 patients with moderately to severely active early RA (from ≥3 months' to ≤2 years' duration). Mean duration of disease for these patients was 9 months1,2
  • At baseline: patients were ≥18 years of age, were MTX-naive, had a DAS 28 ≥3.2, had either an ESR ≥28 mm/hr or C-reactive protein (CRP) level ≥20 mg/L, and were within ACR Functional Class I, II, or III1
  • Corticosteroids (≤10 mg/day prednisone or equivalent) and NSAIDs were allowed if the dose was stable for at least 4 weeks prior to baseline. The doses were required to be kept constant through 24 weeks unless the patient experienced an adverse event. DMARDs other than MTX and ENBREL were not allowed1
STUDY DESIGN1:
  • The 2-year COMET study was divided into 2 periods, each lasting 1 year
  • The primary objective was to compare the effects of ENBREL + MTX to MTX on clinical disease activity and radiographic change over 1 year (Period 1) in subjects with active early moderate to severe RA
  • Results for both 1- and 2-year analyses should be viewed in context with the populations evaluated for each time point
  • During Period 1 of the study, patients were randomized to receive once-weekly ENBREL 50 mg in combination with weekly MTX (n=274) or MTX alone (n=268). In both the combination and monotherapy groups, initial MTX therapy dose was 7.5 mg, which was titrated to 15 mg at Week 4 if response was inadequate, and further titrated at Week 8 if patients still responded inadequately (maximum dose was 20 mg/week)
  • From Weeks 8 to 52, the mean (median) MTX therapy doses were: ENBREL + MTX = 16 mg/week (17 mg/week); MTX monotherapy = 17 mg/week (20 mg/week)
TREATMENT GROUPS:
  • Subjects were randomized at the baseline visit equally to 1 of 4 groups3:
    • Group 1A: ENBREL + MTX in Periods 1 and 2
    • Group 1B: ENBREL + MTX in Period 1 and ENBREL alone in Period 2
    • Group 2A: MTX alone in Period 1 and ENBREL + MTX in Period 2
    • Group 2B: MTX in Periods 1 and 2
  • 131 (24.2%) subjects discontinued during Year 1 of the study: 79 (29.5%) in the MTX group and 52 (19.0%) in the ENBREL + MTX treatment group1,3
1-YEAR ENDPOINTS:
  • Clinical endpoints included: DAS 28 clinical remission at Month 12, DAS 44 clinical remission, and ACR 20/50/701,4
  • Radiographic endpoint: change in mTSS at Month 12 (components of TSS are joint space narrowing and joint erosion scores)1
SAFETY ANALYSES:
  • Safety was analyzed using the intent-to-treat (ITT) population (N=542), which was defined as all enrolled subjects in the study who received at least 1 dose of the study drug
EFFICACY ANALYSES:
  • The primary clinical efficacy endpoint was DAS 28 clinical remission (<2.6) at Month 121
  • For Period 1 analyses, the modified ITT (mITT) population included all subjects who received at least 1 dose of drug and had baseline and ≥1 postbaseline DAS 28 results (N=265 for ENBREL + MTX, N=263 for MTX alone)1
  • The primary radiographic endpoint was the change in mTSS over 12 months1
  • Radiographic analyses for Period 1 included only subjects with baseline and follow-up x-rays (N=246 for ENBREL + MTX, N=230 for MTX alone)5

YEAR 2

STUDY DESIGN6:

  • The MTX or MTX-matching placebo dose level at the end of Period 1 was the starting dose level for MTX or MTX-matching placebo in Period 2. Subjects in group 1B (ENBREL + MTX/ENBREL) discontinued MTX by the end of the fourth week of Period 2 (ie, by the start of Month 13 of the study). In Year 2, the mean doses of MTX (mg/week) were similar between groups: 16.19 in group 1A, 16.26 in group 1B (mean MTX dose reported was specific to the withdrawal period [~4 weeks]), 17.83 in group 2A, and 18.03 in group 2B
TREATMENT GROUPS (PERIOD 2):
  • Subjects who met inclusion criteria for Period 1 and completed Period 1 were eligible to participate in Period 26
  • No re-randomization of subjects in Year 25
  • 64 patients discontinued during Year 2: 7 in group 1A, 16 in group 2A, 18 in group 1B, and 23 in group 2B5
2-YEAR ENDPOINTS6:
  • Evaluate the safety of each treatment group during Year 2
  • Compare the effects of ENBREL + MTX to MTX alone on radiographic change and clinical disease activity in Period 2 in subjects who first received MTX alone for 1 year
  • Compare the effects of ENBREL + MTX to ENBREL alone on radiographic change and clinical disease activity in Period 2 in subjects who first received ENBREL + MTX for 1 year
  • Compare the effects of ENBREL + MTX for 2 years to MTX alone for 1 year, followed by ENBREL + MTX on radiographic change and clinical disease activity over 2 years
  • Compare the effects of ENBREL + MTX on radiographic change and clinical disease activity to MTX alone over 2 years
SAFETY ANALYSES4,6:

The ITT population (N=411) was defined as all subjects who received at least 1 dose of study drug during Period 2

EFFICACY ANALYSES:

  • The mITT population was defined as all subjects who received at least 1 dose of study drug and had Year 2 baseline and ≥1 post-Year 2 baseline DAS 28 result(s)3,6
    • For other analyses, fewer subjects may have been included if they were missing data for that particular endpoint
  • Data analyses performed upon completion of Year 2 included data generated by subjects during Year 1 of the COMET study6
  • There were 2 baselines for Year 2 analyses: the original baseline at the beginning of Year 1 and the Year 2 baseline (Week 52)6
  • The radiographic ITT population received at least one dose of study drug and provided data at baseline, Year 1, and during Year 27
  • Nonresponder Imputation (NRI) population analyses included patients who received at least 1 dose of study drug and had at least 1 post-Year 1 baseline on-therapy ACR result (N=488)8
  • Pain, morning stiffness, CRP, HAQ, and complete joint count were evaluated at Weeks 0, 2, 4, 8, 12, 16, 20, 24, 36, 52, 64, 80, and 969
 
Supportive data
Moderate to Severe Rheumatoid Arthritis

In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.

Psoriatic Arthritis

In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Important Safety Considerations

In moderate to severe RA

Learn about DAS 28 clinical remission

View data

ENBREL is the #1 prescribed biologic by rheumatologists*

See why

*6-month average of IMS monthly NPA prescription data by rheumatologists.

IMS NPA prescription data does not include products administered by infusion.

 
 
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