Efficacy in RA

PHYSICAL FUNCTION RESPONSE IN MTX-INADEQUATE–RESPONDER RA PATIENTS

*HAQ-DI=Health Assessment Questionnaire Disability Index. A reduction in HAQ-DI score of ≥ 0.25 is clinically meaningful. The HAQ is a validated questionnaire. It is scored from "0" (no disability) to "3" (completely disabled).

GO-FORWARD^TM was a multicenter, randomized, double-blind, placebo-controlled study in 444 adult patients who had moderately to severely active RA despite a stable dose of ≥15 mg/week of MTX and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥4 swollen joints (out of 66 total) and ≥4 tender joints (out of 68 total) and at least 2 of the following: (1) CRP ≥1.5 mg/dL or erythrocyte sedimentation rate (ESR) by the Westergren method of ≥28 mm/hr, (2) at least 30 minutes of morning stiffness, (3) bone erosion determined by x-ray and/or MRI, or (4) anti-cyclic citrullinated peptide (anti-CCP) antibody–positive or rheumatoid factor (RF)–positive. Patients were randomized to receive placebo + MTX (n=133), SIMPONI^® 50 mg + MTX (n=89), SIMPONI^® 100 mg + MTX (n=89), or SIMPONI^® 100 mg monotherapy + placebo (n=133). The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14. Because the 100 mg dose is not part of the approved dosing regimen for SIMPONI^®, only the 50 mg results are shown. There was no clear evidence of improved ACR response with the higher SIMPONI^® dose group (100 mg).^1,2

SIGNIFICANT ACR & PHYSICAL FUNCTION RESPONSE

SIGNIFICANT ACR RESPONSE IN ANTI-TNF–EXPERIENCED RA PATIENTS

Discontinuation of prior anti-TNF therapies could have been for reasons including lack of efficacy (58%), intolerance (17%), and/or reasons other than safety or efficacy (40%).⁷

SIGNIFICANT ACR RESPONSE AT 14 AND 24 WEEKS WHEN USED WITH OR WITHOUT DMARDs

• 35% of anti-TNF–experienced patients receiving SIMPONI^® 50 mg ± DMARDs achieved an ACR20 response at Week 14 (primary endpoint) vs 18% receiving placebo ± DMARDs (P=0.0006)^1,3
• 34%,18%, and 12% of anti-TNF– experienced patients receiving SIMPONI^® 50 mg ± DMARDs achieved an ACR20, ACR50, and ACR70 response, respectively, at Week 24 vs 17%, 5%, and 3% receiving placebo ± DMARDs (P=0.0005, P=0.0003, P=0.0041, respectively)^1,3

SIGNIFICANT ACR20 RESPONSE AT 4 WEEKS

• Significant ACR20 response achieved as early as the first assessment (Week 4) after only 1 SC dose of SIMPONI^{® 7}

• 27% for SIMPONI^® 50 mg ± DMARDs vs 10% for placebo (P<0.001)⁷

IMPROVES PHYSICAL FUNCTION RESPONSE IN ANTI-TNF–EXPERIENCED RA PATIENTS

*HAQ-DI=Health Assessment Questionnaire Disability Index. A reduction in HAQ-DI score of ≥ 0.25 is clinically meaningful. The HAQ is a validated questionnaire. It is scored from "0" (no disability) to "3" (completely disabled).

GO-AFTER^TM was a multicenter, randomized, double-blind, placebo-controlled study in 461 adult patients with moderately to severely active RA who were previously treated (at least 8-12 weeks prior to administration of study agent) with 1 or more other anti-TNF agents without a serious adverse reaction. Moderately to severely active RA was defined as disease diagnosed per ACR criteria for ≥3 months prior to screening in patients who had at least 4 swollen and 4 tender joints. Patients were randomized to receive placebo (n=155), SIMPONI^® 50 mg (n=153), or SIMPONI^® 100 mg (n=153). The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14. Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine, and/or hydroxychloroquine. Because the 100 mg dose is not part of the approved dosing regimen for SIMPONI^®, only the 50 mg results are shown. There was no clear evidence of improved ACR response with the higher SIMPONI^® dose group (100 mg).^1,3

REDUCES SIGNS AND SYMPTOMS
IN MTX-NAÏVE RA PATIENTS

SIGNIFICANT ACR20 RESPONSE AT 4 WEEKS

• Significant ACR20 response achieved as early as the first assessment (Week 4) after only 1 SC dose of SIMPONI^{® 7}

• 35% for SIMPONI^® 50 mg + MTX vs 22% for MTX alone (P=0.009)⁷

GO-BEFORE^TM was a multicenter, randomized, double-blind, placebo-controlled study in 637 adult patients who had moderately to severely active RA and who had not received more than 3 weekly doses of MTX as treatment for RA. Active RA was defined as ≥4 swollen joints (out of 66 total) and ≥4 tender joints (out of 68 total) and at least 2 of the following: (1) CRP ≥1.5 mg/dL or ESR by the Westergren method of ≥28 mm/hr, (2) at least 30 minutes of morning stiffness, (3) bone erosion determined by x-ray and/or MRI, or (4) anti-CCP antibody–positive or RF-positive. Patients were randomized to receive placebo + MTX (n=160), SIMPONI^® 50 mg + MTX (n=159), SIMPONI^® 100 mg + MTX (n=159), or SIMPONI^® 100 mg monotherapy + placebo (n=159). For patients receiving MTX, MTX was administered at a dose of 10 mg/week beginning at Week 0 and increased to 20 mg/week by Week 8. A primary endpoint was the percentage of patients achieving an ACR50 response at Week 24. Because the 100 mg dose is not part of the approved dosing regimen for SIMPONI^®, only the 50 mg results are shown. There was no clear evidence of improved ACR response with the higher SIMPONI^® dose group (100 mg).^1,4

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