Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 )… FDA label
Also known as Enbrel (etanercept), etanercept, Phase 1: Etanercept, etanercept (genetical recombination), no intervention
Enbrel · 18 trials · 10 indications
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
| Arm | Type | Description |
|---|---|---|
| ETN 50mg QW | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| etanercept | ACTIVE_COMPARATOR | In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| PLACEBO | PLACEBO_COMPARATOR | In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| Enbrel 50 mg Prefilled Syringe | EXPERIMENTAL | Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe |
| Enbrel 50 mg Autoinjector | EXPERIMENTAL | Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector |
| 2 | ACTIVE_COMPARATOR | Arm 2 Enbrel 50 mg Autoinjector |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| etanercept | BIOLOGICAL | 50mg subcutaneous, once weekly, 24 weeks |
| Background NSAID | DRUG | Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician. |
| PLACEBO | OTHER | In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| Enbrel 50 mg Prefilled Syringe | DEVICE | Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe |
| Enbrel 50 mg Autoinjector | DEVICE | Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector |
| Enbrel (etanercept) | DEVICE | Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly |
| Methotrexate | DRUG | up to 8 mg per week, oral dosing for 52 weeks |
Inclusion Criteria: * Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints. * Either the patient or a designee must be capable of administering the subcutaneous injection of study drug. Exclusion Criteria: * Prior treatment with etanercept. * Presence o...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Novartis AG Sponsored ADR | NVS | 2 | - | Secukinumab |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Pfizer Inc. | PFE | 1 | - | tofacitinib |
Enbrel is used to treat ankylosing spondylitis, psoriasis, and rheumatoid arthritis. It is an immunology therapy developed by Pfizer, Inc. (PFE). Clinical development has focused on these inflammatory conditions, with Phase 3 trials completed in ankylosing spondylitis, psoriasis, and rheumatoid arthritis patient populations.
Enbrel is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company associated with the clinical development program for Enbrel across its immunology indications, including ankylosing spondylitis, psoriasis, and rheumatoid arthritis.
Enbrel has been studied in Phase 3 clinical trials. The development program includes completed Phase 3 studies in ankylosing spondylitis, psoriasis, and rheumatoid arthritis. These trials enrolled adults aged 18 years and older and were conducted across multiple European countries.
Enbrel has been evaluated in completed Phase 3 trials including NCT00482170 in psoriasis, NCT00459706 in rheumatoid arthritis, and NCT00434044 and NCT00421915 in ankylosing spondylitis. These studies assessed perceptions and satisfaction with different delivery mechanisms and evaluated etanercept treatment in ankylosing spondylitis patients.
Yes, Enbrel is also known as etanercept. Enbrel (etanercept) is the same therapy, and the two names refer to the same product. Clinical trial records and prescribing information may use either name interchangeably when referring to this immunology treatment developed by Pfizer, Inc.