Try. Test. Tweak. Repeat. Methodical experimentation, collaboration, and refinement have long been critical to the process of innovation.
Based on these methods, the history of progress has steadily advanced by humanity’s urge to never settle for “good enough,” like exploring ways to efficiently produce food that serves more people or finding smarter ways to help golfers better their game.
It’s in that spirit that we continually work toward uncovering the potential of proven moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA) therapies.
Progression Begins with Inquisition
Where can the pursuit of knowledge take us?
Industry innovators refuse to settle and instead continually strive to make good things great. These are their stories.
for moderate to
severe RA and PsA‣
Elevating Food Production
How can understanding the science behind food better suit the complex dietary needs of an ever-changing world?
A (better) Apple a Day
A is for apple allergies
It’s estimated that more than 26 million people in the US have some form of food allergy. Of those, approximately 10.8% have a condition known as Oral Allergy Syndrome (also called Pollen Food Allergy Syndrome) in which the cross-allergenicity between the major birch pollen (Bet v 1 protein) and the major apple allergen (Mal d 1 protein) results in an allergy to a variety of different fruits and vegetables, including apples. For individuals with the Mal d 1 protein allergy, the otherwise nutritious and delicious apple must be avoided due to reactions ranging from an itchy throat to difficulty breathing.
But by modifying a naturally occurring process called RNA interference (RNAi), scientists are working to alter the gene that produces Mal d 1 and ultimately produce an apple that would be safe to eat for those with apple allergies.
Farming for the Future
Is it possible to farm without using soil? Agricultural scientists have developed an approach known as hydroponic farming that, unlike traditional methods, uses soilless alternatives and nutrient-rich irrigation systems to efficiently grow produce. What’s more, hydroponic farming requires far less space and water to grow fresh food compared to traditional farming.
As such, many hydroponic farms can be found on the rooftops of populous city centers growing leafy greens, tomatoes, and peppers that can be harvested for consumption. This often reduces the travel and effort needed to deliver fresh produce into dense cities since many urban farms are already located within city limits.
With a controlled environment, hydroponic farming even allows for some crops to be grown year-round in smaller spaces with conserved water use. In fact, some facilities are able to fit approximately 24 plants per square meter—which is just a few inches more than the space needed for an average household refrigerator.
Decreased space and less water do not mean reduced output. One study demonstrated that hydroponic farming methods produced an average of 11 times more lettuce while using 13 times less water when compared to traditional field farming.
As athletes strive for a competitive edge by pushing the boundaries of their abilities, technical developers experiment with the equipment they use to help them get closer to their goals.
Training the Body With VR
At its inception, virtual reality (VR) had slow uptake. Only since technology has sufficiently advanced has VR been able to deliver on its core promise—perceptual immersion in a virtual environment.
For athletes, realistic simulated environments enable them to experience situations that look and feel real, while not subjecting themselves to risk of injury or overexertion that could adversely affect their performance on game day. Without the dependency of other teammates and an unpredictable outdoor location, VR emulates an ideal training scenario.
Experimenting with Tee Time
The evolving golf club
Manufacturers continuously tweak their golf clubs for a better swing. While experimenting with new materials and construction techniques have produced lighter, faster clubs, they couldn’t critique your every swing or handicap. That’s the job of a swing coach.
But a swing coach can be prohibitively expensive, and some coaching techniques can alter the golfer’s swing so much that it feels like an entirely new movement.
Smart clubs, on the other hand, use a comprehensive array of real-time data to instill a series of smaller corrections to the player’s existing swing, rather than requiring the player to learn a completely new one—which, when combined with a lower cost, can lead to a more enjoyable experience as they improve their game.
In Pursuit of Enhanced Diagnostics
What are the ways in which diagnostic technology is being re-imagined?
Tweaking the Future of MRI
Moving forward with MRI
Magnetic resonance imaging (MRI) has been an essential diagnostic tool for decades, used as a noninvasive technique for detecting ailments ranging from torn ligaments to tumors. Standard MRI methods use magnetism and radiofrequency pulses to excite water nuclei. As the nuclei in different body tissues slow, they produce different signal intensities, the contrast between which is used to create an image. In certain cases, gadolinium is used as a contrast agent to help improve image visibility of inflammation, tumors, blood vessels and blood supply to organs. However, gadolinium injections are not suitable for patients with certain conditions, so it cannot always be relied upon to improve the clarity of images.
In the search for imaging methods that don’t require invasive injections of contrast agents such as gadolinium, researchers are exploring a method known as Chemical Exchange Saturation Transfer (CEST). CEST enables the imaging of certain compounds that are too low to be detected by traditional MRI. By causing the continuous buildup of magnetic saturation that occurs when protons are exchanged between a compound and the water surrounding it, CEST can significantly enhance image sensitivity. In doing so, CEST may eliminate the need for contrast injections, meaning it could potentially be used in more patients and to gain further information on physiological and pathological conditions.
Medical Diagnostics on the Move
More nimble screening machines
For lung cancer patients living in rural tobacco belt counties, reaching the closest computed tomography (CT) scanner required traveling considerable distance to reach the nearest hospital. That’s one hypothesis why patients in these areas may have received later-stage diagnoses and experienced poorer treatment outcomes as a result.
In one recent initiative, stationary CT equipment was tweaked for portability and mounted inside a truck trailer. Doctors were then able to bring it to patients in one remote region to provide timely, advanced screenings for hundreds of patients. They identified 10 cases of lung cancer which may have otherwise gone undetected—four of which were still at stages 1 or 2, when available treatment options are more effective.
Deepening our knowledge
While some healthcare solutions address challenges today, some scientific innovators may redefine the way the world practices medicine for years to come.
We employ research to uncover more unknowns that may help inform rheumatologists in their approach to patient care.
Advancing treatment for moderate to severe RA and PsA
The introduction of biologic therapies was a major advancement in the field of rheumatology. This groundbreaking class of treatments, created from living organisms rather than formulated from chemical substances, transformed the treatment of RA.
In 1998, ENBREL ushered in the era of RA biologics as the first to be approved for the treatment of moderate to severe RA. Since then, we’ve continued to broaden our understanding of moderate to severe RA and PsA, as well as the impact that ENBREL can have on each disease.
See how we’re gathering insights below
Does a phosphate-free formulation impact the patient self-injection experience?
We created a phosphate-free formulation of ENBREL and studied to see how it may impact patients’ self-injection experience.
What role does MTX play in the treatment of PsA?
PsA Pivotal Study: Evaluation of ENBREL in PsA
We wanted to know if ENBREL had the potential to be an effective treatment for patients with PsA.
To find out, we conducted the PsA Pivotal Study, a 24-week randomized, multicenter, double-blind, 3-period study of 205 patients with active PsA, to evaluate the safety, efficacy, and effect on radiographic progression of ENBREL. The 24-week, double-blind period was followed by a maintenance period of up to 24 weeks. At Week 48, the maintenance period was followed by an open-label extension (OLE). The study’s primary endpoints were American College of Rheumatology (ACR) score of 20 at Week 12 and change from baseline in modified Total Sharp Score (mTSS) at Year 1. Eligible patients were randomly assigned to receive placebo or ENBREL. Randomization was stratified by concomitant MTX use at baseline for equal distribution between treatment arms.
Although patients were stratified by MTX use at baseline for equal distribution between the study’s treatment arms, the role of MTX was not evaluated in its own comparator arm.
What role does MTX play in the treatment of PsA?
SEAM-PsA Study: Evaluation of ENBREL and MTX as monotherapies and as combination therapy in PsA
Because MTX was allowed as a background therapy in the PsA Pivotal Study and was not included as a comparator arm, its role in the treatment of PsA in relation to ENBREL was never fully explored. We wanted to know what PsA patients who had never taken a biologic or MTX could achieve with ENBREL monotherapy compared to MTX or how ENBREL + MTX performed compared to MTX.
So we conducted the Study of Entanercept and Methotrexate (SEAM) PsA Study, a 48–week, multicenter, randomized, double-blind, controlled study of 851 patients with active PsA. The primary endpoint for SEAM-PsA was ACR 20 at Week 24.
For moderate to severe RA patients on combination therapy with sustained remission, Can remission be maintained with ENBREL or MTX as monotherapy?
Identifying therapeutic options beyond ENBREL + MTX combination therapy meant understanding how MTX alone compared in providing sustained efficacy for patients with moderate to severe RA.
The TEMPO Study: Evaluation of ENBREL + MTX vs MTX in moderate to severe RA patients
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.1
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 MTX1*
- Change from baseline in mTSS at 52 weeks: -0.5 for ENBREL + MTX, 0.2 for ENBREL and 1.9 for MTX2†
ADDITIONAL EFFICACY ENDPOINTS AND RESULTS
- ACR 20/50/70 was achieved by 85%/67%/49% of patients with ENBREL + MTX, 72%/46%/24% with ENBREL, and 68%/43%/22% with MTX at Year 31
*ENBREL + MTX vs MTX (P<0.0001); ENBREL vs MTX (P=0.0034); ENBREL + MTX vs ENBREL (P<0.0001)1
†ENBREL + MTX vs MTX (P<0.01); ENBREL vs MTX (P<0.01); ENBREL + MTX vs ENBREL (P<0.01)1
‡Remission is defined as DAS 28 <2.6 units. Clinical remission does not mean drug-free remission or complete absence of disease.3
§P<0.001 vs MTX monotherapy.3
NRI, nonresponder imputation.
While combination therapy for bio-naïve patients is consistent with major guidelines including ACR and EULAR, could patients with good disease control maintain remission with ENBREL or MTX as monotherapy?
References: 1. Data on file, Amgen; TEMPO CSR 57599 3 yr Clinical. June 21, 2005. 2. Data on file, Amgen; TEMPO CSR 57599 3 yr Radiographic. November 22, 2005. 3. Data on file, Amgen; DAR TEMPO COMET DAS 28 Remission NRI. August 26, 2020.
Can moderate to severe RA patients treated with combination therapy maintain remission with ENBREL or MTX as monotherapy?
2020 SEAM-RA Study: Evaluation of ENBREL and MTX as monotherapies to maintain SDAI remission in patients withdrawing from combination therapy
For moderate to severe RA patients who have reached sustained SDAI remission, we sought to determine if such patients could maintain remission by taking either ENBREL or MTX alone.
To find out, we conducted the Study of Etanercept And Methotrexate in Combination or as Monotherapy in patients with Rheumatoid Arthritis (SEAM-RA). 253 patients on ENBREL + MTX maintaining Simplified Disease Activity Index (SDAI) remission through a 24-week open-label period entered a 48-week, double-blind period and were randomized to receive ENBREL + MTX, ENBREL, or MTX.
The primary endpoint was the proportion of patients in SDAI remission without disease-worsening at Week 48 in the ENBREL-monotherapy vs MTX-monotherapy arms.
Good is never good enough
From investing in ongoing clinical research to finding new ways to support patients, we continue to explore the unknowns in the treatment of moderate to severe RA and PsA, equipping you with additional knowledge to help in your treatment of patients.