Updated October 09, 2014.
This article is part of the Arthritis Archives.
Dateline: October 29, 2002
There are more reasons than ever to consider Enbrel (etanercept) an important treatment option for arthritis. Since being approved by the U.S. Food and Drug Administration (FDA) in 1998, Enbrel has been prescribed to more than 129,000 patients.
On October 24, 2002, Amgen announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA requesting an additional indication for Enbrel "to inhibit the progression of structural damage in psoriatic arthritis patients".
The request for the expanded indication is based on results of a 12-month, double-blind, placebo-controlled study. The FDA approved Enbrel "to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis" in January, 2002.
There is also another sBLA currently under consideration by the FDA which requests Enbrel be indicated to "improve physical function in patients with rheumatoid arthritis". If the FDA approves these two applications, the indications would be added to the already existing indications for use of Enbrel:
At the annual meeting of the American College of Rheumatology (ACR) in New Orleans, October 25-29, 2002, results from a study assessing 5 years of Enbrel monotherapy as a treatment for RA patients who had previously failed DMARD therapy were shared. 629 adult patients are involved in this ongoing study. 319 patients have been observed for between 4 and 5 years. 68 of the patients have been observed for 5 years or more. Of the patients observed for 5 years:
From the long-term study it was also determined that:
In an ongoing study of patients with early-erosive rheumatoid arthritis, it was reported during the ACR meeting that Enbrel provided improvement in signs and symptoms which was sustained over 4 years. Also, 58% of 142 patients who remained on Enbrel for 3 years had no radiographic progression of their disease.
Patients in the ongoing, open-label study initially were participants in a 2-year, double-blind, multicenter trial which evaluated the efficacy of Enbrel or methotrexate to treat early, erosive RA. The ongoing, open-label study includes the patients randomized to receive Enbrel 25 mg twice weekly in the original study who continued this dose, and includes 143 patients previously receiving methotrexate who chose to be treated with Enbrel.
For those patients originally treated with Enbrel 25 mg twice weekly, observed at 4 years:
In this particular study, there was no increase in serious infections, malignancies, or significant adverse events in the Enbrel group compared to the methotrexate group from the original controlled study.
Sources:
Enbrel Only TNF Receptor With Five Years Sustained Data In Treatment of Rheumatoid Arthritis, PRNEWSWIRE, October 25, 2002.
Enbrel First Therapy Submitted to FDA Showing Inhibition of Bone and Joint Damage in Psoriatic Arthritis Patients, PRNEWSWIRE, October 24, 2002.
First published: 10/29/2002
This article is part of the Arthritis Archives.
Dateline: October 29, 2002
Amgen Requests Additional Indications for Enbrel
There are more reasons than ever to consider Enbrel (etanercept) an important treatment option for arthritis. Since being approved by the U.S. Food and Drug Administration (FDA) in 1998, Enbrel has been prescribed to more than 129,000 patients.
On October 24, 2002, Amgen announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA requesting an additional indication for Enbrel "to inhibit the progression of structural damage in psoriatic arthritis patients".
The request for the expanded indication is based on results of a 12-month, double-blind, placebo-controlled study. The FDA approved Enbrel "to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis" in January, 2002.
There is also another sBLA currently under consideration by the FDA which requests Enbrel be indicated to "improve physical function in patients with rheumatoid arthritis". If the FDA approves these two applications, the indications would be added to the already existing indications for use of Enbrel:
- to reduce the signs and symptoms in patients with moderately to severely active rheumatoid arthritis (RA).
- to inhibit the progression of bone and joint damage in patients with moderately to severely active rheumatoid arthritis.
- to be used without methotrexate to treat patients with moderately and severely active rheumatoid arthritis.
- to treat patients 4 years of age and older with moderately to severely active polyarticular juvenile rheumatoid arthritis who have had an inadequate response to DMARDs (disease-modifying anti-rheumatic drugs).
- to treat newly diagnosed rheumatoid arthritis patients with moderately to severely active disease.
- to treat active arthritis in patients with psoriatic arthritis (PA).
Long-Term Monotherapy Study Of Enbrel To Treat RA
At the annual meeting of the American College of Rheumatology (ACR) in New Orleans, October 25-29, 2002, results from a study assessing 5 years of Enbrel monotherapy as a treatment for RA patients who had previously failed DMARD therapy were shared. 629 adult patients are involved in this ongoing study. 319 patients have been observed for between 4 and 5 years. 68 of the patients have been observed for 5 years or more. Of the patients observed for 5 years:
- 71% achieved ACR 20
- 48% achieved ACR 50
- 27% achieved ACR 70
- 24% had no tender or swollen joints
- 16% had no disability as measured by the HAQ (Health Assessment Questionnaire)
From the long-term study it was also determined that:
- Enbrel was generally well-tolerated.
- There was no increase in rate of serious adverse events.
- The serious infection rate in the long-term study was comparable to Enbrel-treated patients and placebo-patients in previous controlled studies.
- The number of malignancies was in line with what was expected (16 actual vs. 20 predicted).
- No opportunistic infections were observed.
New Radiographic Data From Ongoing 4-Year Study To Treat Early, Erosive RA
In an ongoing study of patients with early-erosive rheumatoid arthritis, it was reported during the ACR meeting that Enbrel provided improvement in signs and symptoms which was sustained over 4 years. Also, 58% of 142 patients who remained on Enbrel for 3 years had no radiographic progression of their disease.
Patients in the ongoing, open-label study initially were participants in a 2-year, double-blind, multicenter trial which evaluated the efficacy of Enbrel or methotrexate to treat early, erosive RA. The ongoing, open-label study includes the patients randomized to receive Enbrel 25 mg twice weekly in the original study who continued this dose, and includes 143 patients previously receiving methotrexate who chose to be treated with Enbrel.
For those patients originally treated with Enbrel 25 mg twice weekly, observed at 4 years:
- 79% achieved ACR 20
- 58% achieved ACR 50
- 31% achieved ACR 70
In this particular study, there was no increase in serious infections, malignancies, or significant adverse events in the Enbrel group compared to the methotrexate group from the original controlled study.
Related Resources
- Enbrel (etanercept)
- TNF Blockers (Enbrel, Remicade, Humira) - Test Your Knowledge
- Psoriatic Arthritis
- Rheumatoid Arthritis
Sources:
Enbrel Only TNF Receptor With Five Years Sustained Data In Treatment of Rheumatoid Arthritis, PRNEWSWIRE, October 25, 2002.
Enbrel First Therapy Submitted to FDA Showing Inhibition of Bone and Joint Damage in Psoriatic Arthritis Patients, PRNEWSWIRE, October 24, 2002.
First published: 10/29/2002