Simponi 5-Year Data Shows Improvement in Majority of RA Patients

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Janssen Biotech announced new five-year data from three pivotal Phase 3 studies evaluating Simponi (golimumab) 50mg administered subcutaneously once every four weeks in the treatment of moderately to severely active rheumatoid arthritis (RA). Among patients continuing treatment with Simponi 50mg in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs) through five years, between 60% and 85% of patients experienced at least a 20% improvement in American College of Rheumatology criteria (ACR 20) at the end of the treatment period.

GO-FORWARD, GO-BEFORE and GO-AFTER are Phase 3, randomized, multicenter, placebo-controlled trials evaluating the safety and efficacy of subcutaneous Simponi as treatment for moderately to severely active RA in multiple patient populations including those naive to methotrexate (GO-BEFORE), those with active disease despite methotrexate (GO-FORWARD), and those who had received previous anti-TNF agents (GO-AFTER). Long-term extensions began at week 24 (GO-AFTER) or week 52 (GO-FORWARD and GO-BEFORE), with the last Simponi injection occurring at week 252.  Observed efficacy results are reported through weeks 256. An analysis using observed data from each of the three trials reported findings on signs and symptoms, disease activity and physical function among these patients. The Phase 3 development program evaluated both Simponi 50mg and 100mg however the Simponi 100mg dose is not approved in the U.S.

In GO-BEFORE, patients were randomized to receive placebo and methotrexate (n=160), Simponi 100mg (n=159), Simponi 50mg and methotrexate (n=159), or Simponi 100mg and methotrexate (n=159). Patients receiving placebo and methotrexate crossed over to receive Simponi and methotrexate at weeks 28 or 52.  Sixty-six percent of methotrexate-naive patients remained in the trial through the five years. After the last patient completed week 52 and the study became unblinded, patients receiving placebo and methotrexate were eligible to cross over to receive Simponi 50mg and methotrexate.  Further, methotrexate and corticosteroid use could be adjusted and a one-time Simponi dose increase and decrease was permitted at the investigator's discretion. Among the patients randomized to receive Simponi 50mg in combination with methotrexate, 85% (92/108) of patients achieved an ACR 20 response and 67% (72/108) of patients achieved ACR 50 response, defined as at least a 50% improvement in arthritis signs and symptoms, at week 256.  


In GO-FORWARD, patients were randomized to receive placebo and methotrexate (n=133), Simponi 100mg and placebo (n=89), Simponi 50mg and methotrexate (n=89), or Simponi 100mg and methotrexate (n=89).  Patients receiving placebo and methotrexate crossed over to receive Simponi and methotrexate at week 16 or 24.  Seventy percent of the patients remained in the trial through five years.  After the last patient completed week 52 and the study became unblindedmethotrexate and corticosteroid use could be adjusted, and a one-time Simponi dose increase and decrease was permitted at the investigator's discretion. Seventy-seven percent (57/74) of patients randomized to receive 50mg in combination with methotrexate achieved ACR 20, and 54% (40/74) of patients randomized to receive Simponi 50mg with methotrexate achieved ACR 50 at week 256.  The study also evaluated patients' disease activity and physical function at five years as demonstrated by HAQ-DI score improvement of at least 0.25, observed in 74% (55/74) of patients randomized to receive Simponi 50mg with methotrexate. 

In GO-AFTER patients with moderately to severely active RA previously treated with TNF inhibitors received treatment with Simponi 50mg through five years. Patients were randomized to receive placebo +/- DMARDs (n=150), Simponi 50mg +/- DMARDs (n=147) or Simponi 100mg +/- DMARDs (n=148), and those receiving placebo crossed over to receive Simponi 50mg at week 16 or 24. Of the 461 patients initially randomized in the study, 40% remained in the trial through five years.  After the last patient completed week 24 and the study became unblinded, a one-time Simponi dose increase and decrease was permitted at the investigator's discretion. After five years, 60% (39/65) of patients randomized to receive Simponi 50mg +/- DMARDs and 65% (37/57) of patients in the placebo group who crossed over to receive Simponi +/- DMARDs achieved ACR 20.

Simponi  is a human monoclonal antibody already approved by the FDA as a subcutaneous injection for the treatment of moderately to severely active RA with methotrexate, active psoriatic arthritis alone or with methotrexate and active ankylosing spondylitis.

For more information call (800) 526-7736 or visit www.janssenbiotech.com.
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