FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX

DEMONSTRATED SYMPTOM CONTROL IN MODERATELY TO SEVERELY ACTIVE RA

ACR20 RESPONSE RATES OVER TIME

ACR20 RESPONSE RATE THROUGH WEEK 1001-4*

BLINDED, PLACEBO-CONTROLLED PHASE (WEEKS 0-24)†

ACR20 response at Week 14 (primary endpoint):

59%

Fifty Nine Percent
of patients receiving
SIMPONI ARIA® + MTX (231/395)
achieved ACR20 response (P<0.001)
versus icon

25%

Twenty Five Percent
of patients receiving placebo +
MTX (49/197)1-3

Rapid ACR20 response at Week 2:

33%

Thirty Three Percent
of patients receiving
SIMPONI ARIA® + MTX (131/395)
achieved ACR20 response
versus icon

12%

Twelve Percent
of patients receiving placebo +
MTX (23/197)1-3

ACR20 response at Week 24:

63%

Sixty Three Percent
of patients receiving
SIMPONI ARIA® + MTX (248/395)
achieved ACR20 response
versus icon

32%

Thirty Two Percent
of patients receiving placebo +
MTX (63/197)1-3

ACR20 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

ACR 20 response Rate Graph

WEEK 24 CROSSOVER‡§

ACR20 response at Week 52‡§:

66%

of patients receiving SIMPONI ARIA® + MTX (n=395) achieved ACR20 response
versus icon

61%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)2

OPEN-LABEL EXTENSION||

ACR20 response through Week 100||:

69%

of patients receiving SIMPONI ARIA® + MTX (n=395) achieved ACR20 response
versus icon

66%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)4
ACR20 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*The same patients may not have responded at each time point.

†In this ITT analysis, patients were considered to be nonresponders if they experienced any of the following: increased MTX dose above baseline for RA; initiated treatment with DMARDs (including commercial MTX), systemic immunosuppressives, and/or biologics for RA; initiated treatment with oral corticosteroids for RA above baseline dose or received IV or intramuscular corticosteroids for RA; or discontinued treatment due to an unsatisfactory therapeutic effect. Last observation carried forward rules were applied to missing data. The patients who early escaped at Week 16 also had Week 16 data carried forward up through Week 24.

‡At Week 24, all remaining patients in the placebo + MTX group began receiving SIMPONI ARIA® + MTX in a blinded manner.

§In this ITT analysis, all rules were nullified and reapplied after Week 24. Patients were considered to be nonresponders if they discontinued treatment due to an unsatisfactory therapeutic effect.

||At Week 52, all study personnel were unblinded to subject-level data.

Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8w through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8w in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8w in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.2
ACR20=20% improvement in American College of Rheumatology criteria; ACR50=50% improvement in American College of Rheumatology criteria; ACR70=70% improvement in American College of Rheumatology criteria; CCP=cyclic citrullinated peptide; CRP=C‑reactive protein; DMARD=disease-modifying anti-rheumatic drug; ITT=intention-to-treat; IV=intravenous; MTX=methotrexate; q8w=every 8 weeks; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor.
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ACR50 RESPONSE RATES OVER TIME

ACR50 RESPONSE RATE THROUGH WEEK 1001-4*

BLINDED, PLACEBO-CONTROLLED PHASE (WEEKS 0-24)†

ACR50 response at Week 14:

30%

Thirty Percent
of patients receiving
SIMPONI ARIA® + MTX (118/395)
achieved ACR50 response
versus icon

9%

Nine Percent
of patients receiving placebo +
MTX (17/197)1-3

ACR50 response at Week 24:

35%

Thirty Five Percent
of patients receiving
SIMPONI ARIA® + MTX (138/395)
achieved ACR50 response
(P<0.001)
versus icon

13%

Thirteen Percent
of patients receiving placebo +
MTX (26/197)1-3

ACR50 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

ACR 20 response Rate Graph

WEEK 24 CROSSOVER†‡

ACR50 response at Week 52§:

39%

of patients receiving SIMPONI ARIA® + MTX (153/395) achieved ACR50 response
versus icon

32%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (62/197)2

OPEN-LABEL EXTENSION||

ACR50 response through Week 100||:

45%

of patients receiving SIMPONI ARIA® + MTX (178/395) achieved ACR50 response
versus icon

41%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (81/197)4
ACR50 responses at Week 2 and Week 14 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*The same patients may not have responded at each time point.

†In this ITT analysis, patients were considered to be nonresponders if they experienced any of the following: increased MTX dose above baseline for RA; initiated treatment with DMARDs (including commercial MTX), systemic immunosuppressives, and/or biologics for RA; initiated treatment with oral corticosteroids for RA above baseline dose or received IV or intramuscular corticosteroids for RA; or discontinued treatment due to an unsatisfactory therapeutic effect. Last observation carried forward rules were applied to missing data. The patients who early escaped at Week 16 also had Week 16 data carried forward up through Week 24.

‡At Week 24, all remaining patients in the placebo + MTX group began receiving SIMPONI ARIA® + MTX in a blinded manner.

§In this ITT analysis, all rules were nullified and reapplied after Week 24. Patients were considered to be nonresponders if they discontinued treatment due to an unsatisfactory therapeutic effect.

||At Week 52, all study personnel were unblinded to subject-level data.

Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8w through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8w in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8w in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.2
ACR20=20% improvement in American College of Rheumatology criteria; ACR50=50% improvement in American College of Rheumatology criteria; ACR70=70% improvement in American College of Rheumatology criteria; CCP=cyclic citrullinated peptide; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; ITT=intention-to-treat; IV=intravenous; MTX=methotrexate; q8w=every 8 weeks; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor.
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ACR70 RESPONSE RATES OVER TIME

ACR70 RESPONSE RATE THROUGH WEEK 1001-4*

BLINDED, PLACEBO-CONTROLLED PHASE (WEEKS 0-24)†

ACR70 response at Week 14:

12%

Twelve Percent
of patients receiving
SIMPONI ARIA® + MTX (49/395)
achieved ACR70 response
versus icon

3%

Three Percent
of patients receiving placebo +
MTX (6/197)1-3

ACR70 response at Week 24:

18%

Eighteen Percent
of patients receiving
SIMPONI ARIA® + MTX (69/395)
achieved ACR70 response
versus icon

4%

Four Percent
of patients receiving placebo +
MTX (8/197)1-3

ACR70 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

ACR 70 response Rate Graph

WEEK 24 CROSSOVER†‡

ACR70 response through Week 52:

18%

of patients receiving
SIMPONI ARIA® + MTX (n=395)
achieved ACR70 response
versus icon

15%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)2

OPEN-LABEL EXTENSION||

ACR70 response through Week 100||:

23%

of patients receiving
SIMPONI ARIA® + MTX (n=395)
achieved ACR70 response
versus icon

24%

of patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)4
ACR70 responses at Week 2, Week 14, and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*The same patients may not have responded at each time point.

†In this ITT analysis, patients were considered to be nonresponders if they experienced any of the following: increased MTX dose above baseline for RA; initiated treatment with DMARDs (including commercial MTX), systemic immunosuppressives, and/or biologics for RA; initiated treatment with oral corticosteroids for RA above baseline dose or received IV or intramuscular corticosteroids for RA; or discontinued treatment due to an unsatisfactory therapeutic effect. Last observation carried forward rules were applied to missing data. The patients who early escaped at Week 16 also had Week 16 data carried forward up through Week 24.

‡At Week 24, all remaining patients in the placebo + MTX group began receiving SIMPONI ARIA® + MTX in a blinded manner.

§In this ITT analysis, all rules were nullified and reapplied after Week 24. Patients were considered to be nonresponders if they discontinued treatment due to an unsatisfactory therapeutic effect.

||At Week 52, all study personnel were unblinded to subject-level data.

Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8w through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8w in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8w in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.2
ACR20=20% improvement in American College of Rheumatology criteria; ACR50=50% improvement in American College of Rheumatology criteria; ACR70=70% improvement in American College of Rheumatology criteria; CCP=cyclic citrullinated peptide; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; ITT=intention-to-treat; IV=intravenous; MTX=methotrexate; PsA=psoriatic arthritis; q8w=every 8 weeks; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor.
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References: 1. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 2. Data on file. Johnson & Johnson. 3. Weinblatt ME, Bingham CO III, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72:381-389. 4. Bingham CO III, Mendelsohn AM, Kim L, et al. Arthritis Care Res (Hoboken). 2015;67(12):1627-1636.