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Indications
ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone. Read more

ENBREL is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). ENBREL can be used with or without MTX.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. Close

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For patients with moderate to severe RA, the passage of time often brings change—both to their lives as well as their state of disease. And just as patients adapt to these changes, their rheumatologists monitor and evaluate whether their treatment plan can be adjusted to better fit their needs. Recognizing the chronic nature of RA, we sought clinical evidence to support rheumatologists as they adapt treatments within the dynamic nature of patient management.

See what we discovered

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Rolling with the changes in moderate to severe RA


Rolling

with the

changes in

moderate

to severe RA

What do your patients’ treatment goals reveal about their lives?

A 1997 study found that RA patients visited their rheumatologist a median 7.2 times a year1

Building

a strong

connection

Think about the RA patients you’ve known for years. Chances are, you’ve gotten to know many of them pretty well over time. One reason for this is purely logistical, as rheumatologists tend to spend a significant amount of time with their RA patients. These long-term connections are oftentimes forged by the shared goal of overcoming the challenge of living with RA.

Taking
time

In a 2017 study, 45% of rheumatologists reported spending an average of 17–24 minutes with their patients per visit, while 32% reported 13–16 minutes2

But whether those relationships have grown strong during the treatment journey or are just beginning, it’s how rheumatologists invest in listening and monitoring each patient that gives them a deep understanding. Treating them as whole people, rheumatologists see how RA has affected their patients to understand better how their treatment choices can help address their needs.

But whether those relationships have grown strong during the treatment journey or are just beginning, it’s how rheumatologists invest in listening and monitoring each patient that gives them a deep understanding.

Treating them as whole people, rheumatologists see how RA has affected their patients to understand better how their treatment choices can help address their needs.

 
 

Life
happens

The knowledge of their RA patients’ lives provides rheumatologists with a unique view of how change affects them. And while change is a fact of life for everyone, for those living with RA these changes can be complicated by their condition. At times, patients’ physical and life changes may call for rheumatologists’ know-how to adjust treatment over the course of their patients’ care.

The knowledge of their RA patients’ lives provides rheumatologists with a unique view of how change affects them.

And while change is a fact of life for everyone, for those living with RA these changes can be complicated by their condition.

At times, patients’ physical and life changes may call for rheumatologists’ know-how to adjust treatment over the course of their patients’ care.

 
 

Preparing
for change

While rheumatologists can diagnose and treat patients without developing long-term relationships, many form personal connections with their RA patients and with that connection, may provide a deeper understanding of what they may need from their treatment over time. But it takes trusted clinical evidence to put that understanding into practice.

While rheumatologists can diagnose and treat patients without developing long-term relationships, many form personal connections with their RA patients and with that connection,

may provide a deeper understanding of what they may need from their treatment over time. But it takes trusted clinical evidence to put that understanding into practice.

The ongoing search for new clinical evidence

The ongoing search for new clinical evidence

Just as rheumatologists adapt to the changes in their patients’ lives over time, we’ve been exploring new clinical insights about treating RA with ENBREL in order to help. Rigorous clinical research has enabled us to continue building a deeper understanding of how ENBREL can help rheumatologists adapt treatments to fit the changing needs of their patients, including a study published in 2020 in patients with moderate to severe RA.3

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First, the foundational TEMPO Study established the use of ENBREL in combination with MTX when treating moderate to severe RA.

Study design

A 3-year, multicenter, double-blind, randomized, controlled trial of 682 patients with moderately to severely active RA with mean disease duration of 6.6 years who had an inadequate response to at least one prior DMARD but were not refractory to MTX.4,5

Primary efficacy endpoints and results

Numeric index of the ACR response (ACR-N) area under the curve (AUC) at 24 weeks:

18.3% years with ENBREL + MTX, 14.7% years with ENBREL, and 12.2% years with MTX5*

Change from baseline in mTSS at 52 weeks:

–0.5 for ENBREL + MTX, 0.2 for ENBREL, and 1.9 for MTX6†

*ENBREL + MTX vs MTX (P<0.0001); ENBREL vs MTX (P=0.0034); ENBREL + MTX vs ENBREL (P<0.0001).5

†ENBREL + MTX vs MTX (P<0.01); ENBREL vs MTX (P<0.01); ENBREL + MTX vs ENBREL (P<0.01).6

Later, the COMET Study—the first in which ENBREL was assessed with remission as the primary endpoint—evaluated different treatment approaches with ENBREL and their impact on clinical remission.

Study design

A 2-year, multicenter, randomized, double-blind, 2-period study of 542 patients with moderately to severely active RA (from ≥3 months’ to ≤2 years’ duration).7

  • In Year 1 of the study, patients were randomized to receive once-weekly ENBREL 50 mg with MTX (up to 20 mg) or MTX alone7
  • At Year 2, the original combination group either continued combination therapy or received ENBREL monotherapy; the original MTX monotherapy group either received combination therapy or continued monotherapy8

Primary efficacy endpoints and results

DAS-28 remission (DAS-28 <2.6) at Year 1:

achieved by 49.8% of patients with ENBREL + MTX vs 27.8% with MTX at Year 1 (P<0.001) in an observed analysis9

Change from baseline in mTSS at Year 1:

0.27 for ENBREL + MTX vs 2.44 for MTX (P<0.001)10

ACR, American College of Rheumatology response; COMET, Combination of Methotrexate and Etanercept in Early Rheumatoid Arthritis Trial; DAS 28, disease activity index in 28 joints; DMARD, disease-modifying antirheumatic drug; mTSS, modified total Sharp score; MTX, methotrexate; RA, rheumatoid arthritis; TEMPO, Trial of Etanercept and Methotrexate With Radiographic Patient Outcomes.

Knowing that the COMET Study revealed about 45% of patients achieve DAS 28 remission on ENBREL + MTX in Year 111*, we wanted to know if patients could maintain remission with ENBREL monotherapy.

*P<0.001 vs MTX.11

So we conducted the SEAM-RA Study.

SEAM-RA: The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Rheumatoid Arthritis

SEAM-RA studied patients who had previously achieved SDAI remission with ENBREL + MTX combination therapy who, after a brief open-label run-in period, were randomized to either receive ENBREL or MTX monotherapy.

Study design

A multicenter, randomized withdrawal, double-blind controlled study in patients with moderate to severe RA on ENBREL + MTX who had good disease control for 6 months before study entry. The study consisted of a 30-day screening period, a 24-week open-label run-in period, a 48-week double-blind treatment period, and a 30-day safety follow-up period.12

Primary endpoint12

  • Proportion of patients in SDAI remission (SDAI ≤ 3.3) at Week 48 without disease-worsening on ENBREL monotherapy compared with MTX alone

Selected secondary endpoints12

  • Proportion of patients with disease-worsening and time to disease-worsening
  • Time to recapture SDAI remission after initiating ENBREL + MTX rescue therapy, the proportion of patients with disease-worsening who recaptured SDAI remission with rescue therapy, and their SDAI scores over time

Maintaining Remission 

After 48 weeks, ENBREL monotherapy helped patients maintain SDAI remission

ENBREL monotherapy is superior to MTX alone and similar to ENBREL + MTX in maintaining SDAI remission without disease-worsening. Patients classified as experiencing disease-worsening had an increased SDAI of >3.3 and ≤11 on two consecutive visits at least 2 weeks apart, or an SDAI of >3.3 and ≤11 at any time on three or more separate visits, or an SDAI of >11 at any time after randomization.3

* Nonresponder imputation. The primary analysis set included all randomized subjects. The analysis was conducted according to the original randomization assignment regardless of the actual treatment received during the study (as per intent-to-treat principle).
ENBREL + MTX vs MTX monotherapy. The risk difference and its P value were estimated from the Chi-squared test with continuity correction.
ENBREL monotherapy vs MTX monotherapy. The risk difference and its P value were estimated from the Chi-squared test with continuity correction

Continuing Remission 

SEAM-RA also demonstrated that for patients who achieved remission on ENBREL + MTX, ENBREL monotherapy resulted in continued SDAI remission

During the double-blind period, a cumulative Kaplan-Meier estimate found that more patients on ENBREL monotherapy maintained SDAI remission without disease-worsening compared with those on MTX alone at Week 48.3

Recapturing Remission 

Finally, most of the patients who received rescue therapy in the SEAM-RA study recaptured SDAI remission

Based on results of ENBREL’s open-label studies, after discontinuation of ENBREL, symptoms of arthritis generally returned within a month. Reintroduction of treatment with ENBREL after discontinuations of up to 18 months resulted in the same magnitudes of response as in patients who received ENBREL without interruption of therapy.14

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Discuss the Data >

References: 1. Ward MM. Rheumatology visit frequency and changes in functional disability and pain in patients with rheumatoid arthritis. J Rheumatol. 1997;24(1):35-42. 2. Grisham S. Medscape Rheumatologist Physician Compensation Report 2017. Medscape website. April 12, 2017. Accessed May 26, 2021. https://www.medscape.com/slideshow/compensation-2017-rheumatology-6008588#23. 3. Data on file, Amgen; SEAM-RA CSR 20110186. April 23,2020. 4. van der Heijde D, Klareskog L, Landewe R, et al; for the TEMPO Study Investigators. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007;56(12):3928-3939. 5. Klareskog L, van der Heijde D, de Jager JP, et al; for the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. Therapeutic effect of the combination of etanercept and methotrexate compare with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. Lancet. 2004;363(9410):675-681. 6. Data on file, Amgen; TEMPO CSR 57599 3 yr Radiographic. November 22, 2005. 7. Emery P, Breedveld FC, Hall S, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomized, double-blind, parallel treatment trial. Lancet. 2008;372:375-382. 8. Emery P, Breedveld FC, van der Heijde D, et al; for the Combination of Methotrexate and Etanercept in Early Rheumatoid Arthritis Trial group. Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthirits: a two-year, double-blind, randomized study. Arthritis Rheum. 2010;62:674-682. 9. Data on file, Amgen; COMET CSR 69344 1 yr Clinical. September 18, 2007. 10. Data on file, Amgen; COMET CSR 71630 1 yr Radiographic. December 7, 2007. 11. Data on file, Amgen; DAR TEMPO COMET DAS 28 Remission NRI. August 26, 2020. 12. Curtis JR, Trivedi M, Haraoui B, et al. Defining and characterizing sustained remission in patients with rheumatoid arthritis. Clin Rheumatol. 2018;37:885-893. 13. Data on file, Amgen; SEAM-RA. Analysis of SDAI Remission by Visit. August 5, 2020. 14. Enbrel (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. March 2020. 15. Data on file, Amgen; SEAM-RA Table 14a-4.1.1.6. July 22, 2020.

* Nonresponder imputation. The primary analysis set included all randomized subjects. The analysis was conducted according to the original randomization assignment regardless of the actual treatment received during the study (as per intent-to-treat principle).
ENBREL + MTX vs MTX monotherapy. The risk difference and its P value were estimated from the Chi-squared test with continuity correction.
ENBREL monotherapy vs MTX monotherapy. The risk difference and its P value were estimated from the Chi-squared test with continuity correction

Analysis is exploratory and has not been adjusted for multiple comparisons.
No conclusions of statistical or clinical significance can be drawn.

As rheumatologists consider how to adapt treatments to changes in patient management…

SEAM-RA provides clinical evidence that patients who have previously achieved remission can maintain it with ENBREL monotherapy.

Dive Deeper Into SEAM-RA

Get answers to questions you may have about the study and see what it means for your moderate to severe RA patients.

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