RESEARCH - Enbrel / methotrexate combination achieved clinical remission in RA patients

[Guest guest]

New study published in the Lancet shows Enbrel/Methotrexate combination

achieved clinical remission in rheumatoid arthritis patients

01 March 2004 | Wyeth

(Copyright © 2004, Wyeth.)

The Enbrel TEMPO (Trial of Etanercept and Methotrexate with Radiographic

Patient Outcomes) study, published today in The Lancet, showed that more

than one third of rheumatoid arthritis (RA) patients treated with Enbrel*

(etanercept) plus methotrexate combination therapy achieved clinical

remission of their disease at one year as measured by the Disease Activity

Score (DAS) criteria.

In this 52-week study, eighty percent of combination-treated patients

experienced no progression of joint damage.1 In addition, patients in the

combination group experienced greater improvement in functionality at one

year compared with other treatment groups.1 Notably, the results indicate

that through the combination of Enbrel and methotrexate therapy, it may be

possible to repair joint damage.

" This is a landmark study in the treatment of rheumatoid arthritis. For the

first time, we have been able to show we can halt the progression of the

disease in a large group of patients, " said Dr Gough, TEMPO

investigator at Harrogate District Hospital.

He continued: " In this study, the patients had already failed treatment with

at least one drug, so to be able to induce sustained remission in over

one-third of patients is fantastic. To be able to show the damaging effects

of the disease are being reversed in many patients was unexpected. This drug

combination has the potential to have a huge impact in terms of improving

patients' quality of life and significantly reducing the need for costly

joint replacement surgery in the future. "

The Enbrel TEMPO study randomised 686 patients with RA, of whom 642 were

included in radiographic analysis for a period of one year. Patients were

assigned to one of three treatment groups: Enbrel (25 mg twice weekly),

methotrexate (up to 20 mg every week), or Enbrel (25 mg twice weekly) plus

methotrexate (up to 20mg every week).1

Clinical remission as assessed by DAS

At one year, 35 percent of patients receiving combination therapy of Enbrel

and methotrexate (n=212) achieved clinical remission as assessed by the

Disease Activity Score (DAS). In comparison, 16 percent of patients treated

with Enbrel alone (n=212) and 13 percent of patients treated with

methotrexate alone (n=212) achieved clinical remission during the same time

period.1 Clinical remission is defined as a DAS of <1.6. DAS is a scoring

system which measures the number of tender and swollen joints, the

erythrocyte sedimentation rate (ESR), (an inflammatory marker), and general

health.

No progression of joint damage

Additionally, 80 percent of combination-treated patients experienced no

progression of joint damage at one year as assessed by the van der

Heijde-modified Total Sharp Score (TSS) (unit change of TSS<0.5), an X-ray

measurement of changes in joint damage.

In comparison, 68 percent of the patients treated with Enbrel monotherapy

and 57 percent of patients treated with methotrexate monotherapy had no

progression of joint damage at one year.

Notably, combination therapy resulted in mean negative radiographic

progression scores, with the entire 95% confidence interval (CI) below zero.

This means that joint x-rays for the combination therapy group were better

at one year compared with at baseline.

Patients treated with Enbrel monotherapy experienced significantly less

progression of joint damage compared with methotrexate monotherapy patients,

with a positive 0.5 unit mean change from baseline at one year in TSS

compared with a positive 2.8 unit mean change,1 respectively.

Improvement in RA symptoms

At one year, a substantial percentage of patients experienced an improvement

in RA symptoms. In the Enbrel and methotrexate combination group, 85 percent

of patients achieved an American College of Rheumatology (ACR) 20 percent

response, 69 percent achieved an ACR 50, and 43 percent of patients achieved

an ACR 70.1 ACR response criteria are a composite measure of improvement in

RA symptoms, including joint swelling and tenderness, pain, level of

disability, overall self- and physician assessment, and an objective marker

of inflammation, such as ESR.

Patients also completed a Health Assessment Questionnaire (HAQ), which

measures functionality. The improvement in functionality reported in the

combination therapy arm was significantly better than in the monotherapy

groups.1

Additionally, Enbrel (monotherapy or in combination with methotrexate) was

well tolerated with no significant differences in side effects amongst the

three groups.1

Notes for editors

Patients in the Enbrel TEMPO trial had active RA and a less than

satisfactory response to at least one disease-modifying antirheumatic drug

(DMARD) other than methotrexate and no previous treatment with TNF

antagonists. The primary radiographic end point was the change from baseline

in the total joint damage score (TSS) over 52 weeks.

Enbrel

Wyeth has applied for regulatory approval of the use of Enbrel in

combination with methotrexate in the EU under the mutual recognition

procedure.

Enbrel has been available in the US since the end of 1998 and was approved

for use in the EU by the European Agency for the Evaluation of Medicinal

Products (EMEA) in February 2000. To date over 200,000 patients worldwide

have been treated with Enbrel. Currently around 4,000 patients are being

treated with Enbrel in the UK.

In adults, Enbrel (etanercept) is licensed for the treatment of active

rheumatoid arthritis when response to disease modifying anti-rheumatic drugs

(DMARDs), including methotrexate, has been inadequate. Enbrel is also

indicated in the treatment of severe, active and progressive rheumatoid

arthritis in adults not previously treated with methotrexate.

Enbrel is also licensed for the treatment of active polyarticular-course

juvenile chronic arthritis in children aged 4 to 17 years who have had an

inadequate response to, or who have proved intolerant of, methotrexate.

Enbrel is also licensed for the treatment of active and progressive

psoriatic arthritis in adults when the response to previous

disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has

also received a license for the treatment of adults with severe active

ankylosing spondylitis (AS) who have had an inadequate response to

conventional therapy.

In the UK, the recommended dose of Enbrel for optimal clinical response in

adults (18-64 years) is 25mg administered twice weekly as a subcutaneous

injection. In rheumatoid arthritis, 25mg administered once weekly gives a

slower response and may be less effective. In psoriatic arthritis and

ankylosing spondylitis, doses other than 25mg administered twice weekly have

not been studied.

1) Klareskog, Dr. Lars, et al. " The Efficacy and Safety of Etanercept

Combined with Methotrexate in Comparison with Etanercept Alone or

Methotrexate Alone in Patients with Rheumatoid Arthritis: Results of the

TEMPO Trial, " draft manuscript for The Lancet

http://www.rheumatoid.org.uk/1/news_pr.php

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

-

Thanks for the article, I do believe that the combo is

what is working so well for me.

Kathe in CA

--- <Matsumura_Clan@...> wrote:

> New study published in the Lancet shows

> Enbrel/Methotrexate combination

> achieved clinical remission in rheumatoid arthritis

> patients

>

> 01 March 2004 | Wyeth

> (Copyright © 2004, Wyeth.)

>

> The Enbrel TEMPO (Trial of Etanercept and

> Methotrexate with Radiographic

> Patient Outcomes) study, published today in The

> Lancet, showed that more

> than one third of rheumatoid arthritis (RA) patients

> treated with Enbrel*

> (etanercept) plus methotrexate combination therapy

> achieved clinical

> remission of their disease at one year as measured

> by the Disease Activity

> Score (DAS) criteria.

>

> In this 52-week study, eighty percent of

> combination-treated patients

> experienced no progression of joint damage.1 In

> addition, patients in the

> combination group experienced greater improvement in

> functionality at one

> year compared with other treatment groups.1 Notably,

> the results indicate

> that through the combination of Enbrel and

> methotrexate therapy, it may be

> possible to repair joint damage.

>

> " This is a landmark study in the treatment of

> rheumatoid arthritis. For the

> first time, we have been able to show we can halt

> the progression of the

> disease in a large group of patients, " said Dr

> Gough, TEMPO

> investigator at Harrogate District Hospital.

>

> He continued: " In this study, the patients had

> already failed treatment with

> at least one drug, so to be able to induce sustained

> remission in over

> one-third of patients is fantastic. To be able to

> show the damaging effects

> of the disease are being reversed in many patients

> was unexpected. This drug

> combination has the potential to have a huge impact

> in terms of improving

> patients' quality of life and significantly reducing

> the need for costly

> joint replacement surgery in the future. "

>

> The Enbrel TEMPO study randomised 686 patients with

> RA, of whom 642 were

> included in radiographic analysis for a period of

> one year. Patients were

> assigned to one of three treatment groups: Enbrel

> (25 mg twice weekly),

> methotrexate (up to 20 mg every week), or Enbrel (25

> mg twice weekly) plus

> methotrexate (up to 20mg every week).1

>

> Clinical remission as assessed by DAS

>

> At one year, 35 percent of patients receiving

> combination therapy of Enbrel

> and methotrexate (n=212) achieved clinical remission

> as assessed by the

> Disease Activity Score (DAS). In comparison, 16

> percent of patients treated

> with Enbrel alone (n=212) and 13 percent of patients

> treated with

> methotrexate alone (n=212) achieved clinical

> remission during the same time

> period.1 Clinical remission is defined as a DAS of

> <1.6. DAS is a scoring

> system which measures the number of tender and

> swollen joints, the

> erythrocyte sedimentation rate (ESR), (an

> inflammatory marker), and general

> health.

>

> No progression of joint damage

>

> Additionally, 80 percent of combination-treated

> patients experienced no

> progression of joint damage at one year as assessed

> by the van der

> Heijde-modified Total Sharp Score (TSS) (unit change

> of TSS<0.5), an X-ray

> measurement of changes in joint damage.

>

> In comparison, 68 percent of the patients treated

> with Enbrel monotherapy

> and 57 percent of patients treated with methotrexate

> monotherapy had no

> progression of joint damage at one year.

>

> Notably, combination therapy resulted in mean

> negative radiographic

> progression scores, with the entire 95% confidence

> interval (CI) below zero.

> This means that joint x-rays for the combination

> therapy group were better

> at one year compared with at baseline.

>

> Patients treated with Enbrel monotherapy experienced

> significantly less

> progression of joint damage compared with

> methotrexate monotherapy patients,

> with a positive 0.5 unit mean change from baseline

> at one year in TSS

> compared with a positive 2.8 unit mean change,1

> respectively.

>

> Improvement in RA symptoms

>

> At one year, a substantial percentage of patients

> experienced an improvement

> in RA symptoms. In the Enbrel and methotrexate

> combination group, 85 percent

> of patients achieved an American College of

> Rheumatology (ACR) 20 percent

> response, 69 percent achieved an ACR 50, and 43

> percent of patients achieved

> an ACR 70.1 ACR response criteria are a composite

> measure of improvement in

> RA symptoms, including joint swelling and

> tenderness, pain, level of

> disability, overall self- and physician assessment,

> and an objective marker

> of inflammation, such as ESR.

>

> Patients also completed a Health Assessment

> Questionnaire (HAQ), which

> measures functionality. The improvement in

> functionality reported in the

> combination therapy arm was significantly better

> than in the monotherapy

> groups.1

>

> Additionally, Enbrel (monotherapy or in combination

> with methotrexate) was

> well tolerated with no significant differences in

> side effects amongst the

> three groups.1

>

> Notes for editors

>

> Patients in the Enbrel TEMPO trial had active RA and

> a less than

> satisfactory response to at least one

> disease-modifying antirheumatic drug

> (DMARD) other than methotrexate and no previous

> treatment with TNF

> antagonists. The primary radiographic end point was

> the change from baseline

> in the total joint damage score (TSS) over 52 weeks.

>

> Enbrel

>

> Wyeth has applied for regulatory approval of the use

> of Enbrel in

> combination with methotrexate in the EU under the

> mutual recognition

> procedure.

>

> Enbrel has been available in the US since the end of

> 1998 and was approved

> for use in the EU by the European Agency for the

> Evaluation of Medicinal

> Products (EMEA) in February 2000. To date over

> 200,000 patients worldwide

> have been treated with Enbrel. Currently around

> 4,000 patients are being

> treated with Enbrel in the UK.

>

> In adults, Enbrel (etanercept) is licensed for the

> treatment of active

> rheumatoid arthritis when response to disease

> modifying anti-rheumatic drugs

> (DMARDs), including methotrexate, has been

> inadequate. Enbrel is also

> indicated in the treatment of severe, active and

> progressive rheumatoid

> arthritis in adults not previously treated with

> methotrexate.

>

> Enbrel is also licensed for the treatment of active

> polyarticular-course

> juvenile chronic arthritis in children aged 4 to 17

> years who have had an

> inadequate response to, or who have proved

> intolerant of, methotrexate.

>

> Enbrel is also licensed for the treatment of active

> and progressive

> psoriatic arthritis in adults when the response to

> previous

> disease-modifying antirheumatic drug therapy has

> been inadequate. Enbrel has

> also received a license for the treatment of adults

> with severe active

> ankylosing spondylitis (AS) who have had an

> inadequate response to

> conventional therapy.

>

> In the UK, the recommended dose of Enbrel for

> optimal clinical response in

> adults (18-64 years) is 25mg administered twice

> weekly as a subcutaneous

> injection. In rheumatoid arthritis, 25mg

> administered once weekly gives a

> slower response and may be less effective. In

> psoriatic arthritis and

> ankylosing spondylitis, doses other than 25mg

> administered twice weekly have

> not been studied.

>

> 1) Klareskog, Dr. Lars, et al. " The Efficacy and

> Safety of Etanercept

> Combined with Methotrexate in Comparison with

> Etanercept Alone or

> Methotrexate Alone in Patients with Rheumatoid

> Arthritis: Results of the

> TEMPO Trial, " draft manuscript for The Lancet

>

> http://www.rheumatoid.org.uk/1/news_pr.php

>

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

Kathe in CA

____________________________________________________

Start your day with - make it your home page

http://www./r/hs