Press Release Details

FOREMOST Study Finds Oral Otezla^® (apremilast) Significantly Improved Disease Control vs. Placebo

THOUSAND OAKS, Calif., Nov. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla^® (apremilast) in patients with early oligoarticular psoriatic arthritis. FOREMOST is the first placebo-controlled study designed to specifically assess people with oligoarticular psoriatic arthritis with early disease duration of five or fewer years. Results will be presented at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15 in San Diego.

"Patients with early oligoarticular psoriatic arthritis who received Otezla were twice as likely as patients receiving placebo to achieve MDA-Joints, a composite endpoint representing minimal disease activity at 16 weeks," said Philip Mease, M.D., MACR, director, Rheumatology Research, Providence Swedish Medical Center, clinical professor, University of Washington School of Medicine, Seattle, and FOREMOST presenting author at ACR. "These patients experienced a significant reduction in psoriatic disease activity, a crucial finding for those in the early stages of the condition."

"Psoriatic arthritis patients with a smaller number of affected joints have been underrepresented in clinical trials, even though oligoarticular psoriatic arthritis is very common and can cause patients significant pain and functional impairment," said Laure Gossec, M.D., Ph.D., professor of rheumatology, Sorbonne Université and Pitié Salpêtrière Hospital, Rheumatology, Paris. "FOREMOST found that people with oligoarticular disease experienced significant improvements with Otezla. This is a key trial, which will help clinicians and patients with this disease type to discuss treatment choices in a data-driven manner."

"Otezla has been studied in numerous trials and prescribed to 840,000 patients, yet we continue to identify unmet needs and opportunity to benefit patients," said Ponda Motsepe-Ditshego, vice president, Global Medical at Amgen. "This research builds on our ongoing goal to reduce the burden of psoriatic disease and improve outcomes for patients." 

The multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 4 FOREMOST study met the primary endpoint of modified minimal disease activity (MDA-Joints) and key secondary endpoints at week 16. In patients with early psoriatic arthritis disease duration (≤5 years) and ≤4 tender and ≤4 swollen joints affected, Otezla plus standard of care doubled the modified minimal disease activity (MDA-Joints) response compared to placebo plus standard of care. In the study, standard of care was defined as nonsteroidal anti-inflammatory drugs (NSAIDs), oral glucocorticosteroids or ≤1 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Detailed study findings include: 

• 33.9% of patients treated with Otezla achieved MDA-Joints response versus 16.0% with placebo, (p=0.0008), the primary endpoint.
• 70.2% of patients treated with Otezla achieved Clinical Disease Activity in psoriatic arthritis (cDAPSA) remission (REM ≤4) or low disease activity (LDA >4 to ≤13) versus 51.8% with placebo, as measured by patient global assessment score (p=0.0017), the key secondary endpoint.
• Common treatment-emergent adverse events (TEAEs) that occurred in more than 5% of Otezla patients were diarrhea (23.0%), nausea (10.8%) and headache (7.8%). TEAEs were consistent with the known safety profile of Otezla.

The study randomized 308 patients with a mean disease duration of 9.9 months, of whom 39.9% were using a csDMARD. MDA-Joints was a composite endpoint consisting of tender joint count ≤1 and swollen joint count ≤1 plus achieving 3 of the following: psoriasis Body Surface Area (BSA) ≤3%, patient assessment of pain visual analog scale (VAS) on a 100-mm scale ≤15, Patient Global Assessment (PtGA) of disease activity on a 100-mm scale ≤20, physical function [HAQ-DI] ≤0.5, and enthesitis count ≤1 based on the Leeds Enthesitis Index.

The FOREMOST oral presentation is one of more than 20 Amgen-sponsored abstracts at ACR highlighting new scientific and clinical research across its expanded rheumatology pipeline.

About Psoriatic Arthritis      
Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis.¹ Around a third of people living with psoriasis may go on to develop psoriatic arthritis.¹ If left untreated, psoriatic arthritis can cause disability. 

About Otezla^® (apremilast)
Otezla^® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide.²

Otezla^® (apremilast) U.S. INDICATIONS 

INDICATIONS

Otezla^® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

Otezla^® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

Contraindications

• Otezla^® is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

• Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
• Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
• Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
• Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
• Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
• Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
• Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
• Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
• Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
• Behçet's Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
• Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

• Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
• Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache
• Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

• Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss.

Please click here for Otezla^® Full Prescribing Information.

About Amgen 
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.

For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, TikTok, YouTube and Threads.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla^® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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CONTACT: Amgen, Thousand Oaks
Kate Meyer, 872-867-0754 (media)
Jessica Akopyan, 805-440-5721 (media)
Justin Claeys, 805-313-9775 (investors) 

References 

¹ National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/psoriasis-statistics/. Accessed October 16, 2023.
² Amgen Data on File. March 2023.

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