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Rheumatoid Arthritis (RA) Studies

Updated on 15/03/2018

IMMUNOLOGY
Rheumatoid Arthritis (RA) Studies

SIMPONI RA indication

SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active RA in combination with methotrexate, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.1

SIMPONI is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX.

In RA patients, SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.1

Pivotal studies

GO-FORWARD: 70% of patients with RA were still responding to SIMPONI at 5 years2

SIMPONI offering high rates of remission at 5 years2

At 5 years, 43% of patients on SIMPONI were in DAS28 remission2*

At week 256, SIMPONI patients achieved:2

*Remission was defined as a DAS28-CRP <2.6

Co-primary endpoints3

ACR20 response at week 14
SIMPONI 50 mg + MTX: 55.1% (n=89)
Placebo + MTX: 33.1% (n=133)
p=0.001

Change from baseline in HAQ-DI score4 at week 24
SIMPONI 50 mg + MTX: -0.38 (n=89)
Placebo + MTX: -0.13 (n=133)
p<0.001

SIMPONI offering significant improvement in patient-reported outcomes at 5 years2

At 5 years, 43% of patients on SIMPONI were in DAS28 remission2*

67% of patients taking SIMPONI had a clinically significant improvement of ≥0.25 in HAQ-DI at week 2562

Co-primary endpoints3

ACR20 response at week 14
SIMPONI 50 mg + MTX: 55.1% (n=89)
Placebo + MTX: 33.1% (n=133)
p=0.001

Change from baseline in HAQ-DI score4 at week 24
SIMPONI 50 mg + MTX: -0.38 (n=89)
Placebo + MTX: -0.13 (n=133)
p<0.001

Study design2

GO-FORWARD: Multicentre, randomised, double-blind, placebo-controlled, 52 week study (with open-label extension up to 256 weeks) of 444 patients with active RA despite treatment with MTX.3

Patients randomised to SIMPONI 50 mg + MTX baseline characteristics:3

  • anti-TNF naïve
  • 81% female
  • median age: 52 years
  • median disease duration: 4.5 years
  • median DAS28-CRP: 5.1
  • proportion of patients receiving MTX ≥1 year: 78%

Group 1: patients who met the criteria for early escape began receiving active golimumab 50 mg every 4 weeks and continued their stable dose of active methotrexate.

Group 2: patients had their sham methotrexate capsules replaced with active methotrexate capsules at the same stable dose that the patient had received at screening and continued to receive injections of golimumab 100 mg every 4 weeks.

Group 3: patients had their golimumab dose increased from 50 mg to 100 mg every 4 weeks and continued to receive their stable dose of active methotrexate.

Group 4: patients had no adjustments made to their subcutaneous or oral study medication.

Overall, 41 patients,36 patients and 15 patients in groups 1, 2 and 3, respectively, met the early escape criteria at week 16. Of the 14 patients in group 4 (100 mg plus methotrexate group) who met the criteria for early escape at week 16 without any dose adjustments, four patients (28.6%) had an ACR20 response at week 24.

OLE, open-label extension

Keystone EC, Genovese MC, Hall S et al. J Rheumatol.2016;43:298-306.

GO-AFTER: 40% of RA patients, previously anti-TNF treated, were still responding to SIMPONI at 5 years7

SIMPONI offering high rates of sustained efficacy over 5 years in previously treated anti-TNF patients7

At 5 years, 60% of patients on SIMPONI achieved a DAS28-CRP response7*

At week 256, SIMPONI patients achieved:7

*66% of SIMPONI patients at baseline were taking MTX7

Primary endpoints8

ACR20 response at week 14
SIMPONI 50 mg ± MTX: 35% (n=153)
Placebo ± MTX: 18% (n=155)
p=0.0006

In established RA, HAQ-DI scores worsen by 1% annually9

44% of patients still taking SIMPONI at week 256 had ≥0.25 improvement in HAQ-DI7†*

baseline HAQ-DI: 1.67
*66% of SIMPONI patients at baseline were taking MTX7

Study design

GO-AFTER: Multicentre, randomised, double-blind, placebo-controlled, 24 week study (with open-label extension up to 256 weeks) of 461 patients with active RA despite treatment with at least one anti-TNF.7,8

Overall, more than 95% of patients had been treated for 4 weeks or more with at least 1 TNF inhibitor, 25% patients had received two and 9% had received three anti-TNFs before enrolment. 48.1% of patients had previously been treated with etanercept.8

Patients randomised to SIMPONI 50 mg baseline characteristics:8

  • 74% female
  • median age: 55 years
  • median disease duration: 9.6 years
  • median DAS28 score: 6.3
  • proportion of patients receiving MTX: 78%

OLE, open-label extension
Subjects with active RA previously treated with anti-TNF treatment (N=461)

Adapted from Smolen JS et al. Lancet 2009; 374:210-221.

Real World Swedish Registry: Bio-naïve patients had higher persistence rates with SIMPONI vs adalimumab or etanercept10

In a retrospective database analysis of patients with rheumatoid disease in Sweden bio-naïve patients had higher persistence rates with SIMPONI compared with adalimumab or etanercept10

In the unadjusted analysis (primary objective), the persistence rate through 3 years was 21% higher with SIMPONI than with etanercept (P=0.004) or adalimumab (P=0.022).10,a

Persistence through 3 years was 21% higher with SIMPONI than with certolizumab pegol, but not statistically significant (P=0.075).10,b

aPSM analysis was carried out to adjust for potential selection bias.10

bPersistence rates through 3 years in the unadjusted analysis: SIMPONI, 40% (N=754); adalimumab, 33% (N=1823); etanercept, 33% (N=1704); certolizumab pegol, 33% (N=622).10

Propensity Score Matching (PSM) analyses of persistence rates with SIMPONI and adalimumab or etanercept through 3 years10

Propensity Score Matching (PSM) analyses of persistence rates with SIMPONI and adalimumab or etanercept through 3 years10

*P=0.042, N=751 propensity score matched pairs. P=0.006, N=718 propensity score matched pairs; Persistence rates at 3 years of RA, PsA, or AS patients receiving treatment with SIMPONI, adalimumab or etanercept; PSM analyses. Patients were defined as non-persistent if they had a gap in treatment exceeding 60 days.

Adapted from Dalén et al. 201610

Persistence was associated with significantly reduced healthcare-related utilisation costs10

ersistence was associated with significantly reduced inpatient and outpatient healthcare-related utilisation costs after initiating treatment, as compared with costs prior to initiation (p<0.001, Wilcoxon signed-rank test).10

Healthcare-related utilisation costs post-initiation as compared with costs prior to initiation10

image Healthcare resource utilisation in the Swedish Registry Study

*P<0.001 vs. prior to initiation. P=0.001 vs. prior to initiation. Healthcare resource utilisation costs were captured on a monthly basis throughout the study, including the 12-month period prior to treatment initiation with a SC TNFα inhibitor. Analysis of costs were carried out on a subset of patients with ≥24 months of follow-up (N=3120), with costs compared between cohorts stratified by persistence status at 12 months after treatment initiation. Patients were defined as non-persistent if they had a gap in treatment exceeding 60 days. The within-cohort difference tested the Wilcoxon signed-rank test. USD = US dollars

Adapted from Dalén et al. 201610

Study design

This Swedish retrospective cohort study explored persistence rates with SC TNFα inhibitors (adalimumab, etanercept, certolizumab pegol, and SIMPONI) over 3 years in patients with RA, psoriatic arthritis, or ankylosing spondylitis (N=4905; 754 patients received SIMPONI). Healthcare resource utilisation costs were captured on a monthly basis throughout the study, including the 12-month period prior to treatment initiation with a SC TNF-α inhibitor. Costs were compared between cohorts stratified by persistence status at 12 months after treatment initiation.10

Adapted from Dalén J, Svedbom A, Black CM et al. Rheumatol Int. 2016;36(7):987-995

Important safety information

AS

SIMPONI is indicated to treat severe, active AS in adults who have responded inadequately to conventional therapy.1

AS GO-RAISE
72% of AS patients, were still responding to SIMPONI at 5 years4

Find out more

PsA

SIMPONI is indicated to treat active and progressive PsA in adults when the response to DMARD therapy has been inadequate.1

GO-REVEAL
69% of PsA patients, were still responding to SIMPONI at 5 years5

Find out more

Related Content

 

References

  1. SIMPONI Summary of Product Characteristics.
  2. Keystone E, et al. J Rheumatol 2016;43: 298–306.
  3. Keystone E, et al. Ann Rheum Dis 2009;68:789–96 and erratum in: Ann Rheum Dis 2011;70:238.
  4. Deodhar A et al. Ann Rheum Dis 2015; 74(4): 757-61.
  5. Kavanaugh A et al. Ann Rheum Dis 2014; 73(9): 1689-1694.
  6. Keystone EC et al. Ann Rheum Dis 2010;69:1129–1135.
  7. Smolen J, et al. Arthritis Res Ther 2015;17:14.
  8. Smolen J, et al. Lancet 2009;374:210–221.
  9. Pollard L, et al. Clin Exp Rheumatol 2005;23(Suppl.39):S43–S52.
  10. Dalen J, Svedbom A, Black CM et al. Treatment persistence among patients with immune-mediated rheumatic disease newly treated with subcutaneous TNF-alpha inhibitors and costs associated with non-persistence. Rheumatol Int. 2016;36(7):987-995.

Supporting documentation

SIMPONI 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Syringe | Patient Information Leaflet for Pre-filled Pen

SIMPONI 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Pen

RHEU-1246537-0000 | Date of Preparation: March 2018