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Table 1 Study designs for PRESERVE, PRIZE, and T2T

From: The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis

Study

RA Status

DMARD history

Period 1 designa

Criteria to enter period 2

Period 2 designa

Primary endpoint

PRESERVE [17]

Moderate (DAS28 > 3.2 and ≤ 5.1)

MTX 15–25 mg QW for 8 weeks prior to screening; bDMARD naive

36 weeks: ETN50 + MTX QW

Sustained LDA (mean DAS28 ≤ 3.2) from weeks 12–36 and DAS28 ≤ 3.2 at week 36

52 weeks:

1. ETN50 + MTX

% patients in the ETN50 + MTX and PBO + MTX groups achieving DAS28 LDA at week 88.b Conditional primary endpoint was DAS28 LDA at week 88 with ETN25 + MTX

2. ETN25 + MTX

3. PBO + MTX, all QW

PRIZE [37]

Moderate-to-severe (DAS28 > 3.2) early RA (symptom onset ≤ 12 months prior to enrollment)

MTX and bDMARD naive

52 weeks: ETN50 + MTX QW

DAS28 ≤ 3.2 at week 39 and DAS28 < 2.6 at week 52

39 weeks:

1. ETN25 + MTX

% patients with sustained remission (DAS28 < 2.6) at weeks 76 and 91 (no corticosteroids from weeks 52 to 64)c

2. PBO + MTX

3. PBO + PBO

T2T [36]

Moderate-to-severe

Inadequate response to MTX

24 weeks: ETN50 + MTX QW ± other csDMARDsd

LDA (DAS28 < 3.2) at week 24

28 weeks:

1. ETN50 + MTX ± other csDMARDsd

% patients with DAS28 LDA at week 52 without rescue medication

     

2. PBO + MTX ± other csDMARDsd

 
  1. bDMARD biologic disease-modifying antirheumatic drug, csDMARD conventional synthetic DMARD, DAS28 Disease Activity Score 28-joint count, ETN etanercept, LDA low disease activity, MTX methotrexate, PBO placebo, QW weekly, RA rheumatoid arthritis, T2T Treat-to-Target
  2. aFor all studies, period 1 was open-label induction and period 2 was double-blind maintenance or withdrawal
  3. bA modified nonresponder imputation analysis was conducted: patients who discontinued due to lack of efficacy were treated as nonresponders
  4. cAll patients who discontinued were considered nonresponders
  5. dSulfasalazine, hydroxychloroquine, and leflunomide