Syringes have continued to evolve over the centuries. Once an experimental surgical procedure, injections are now routinely performed at home by patients. So, we asked ourselves how today’s technology might help change the patient injection process.
How Injections are Evolving
A closer look at the injectors of old
Invented in 1853, the first hypodermic syringe was made almost entirely of steel and bore an intimidatingly large needle. While the materials have changed, and the engineering has improved over the years, the fundamental mechanics of subcutaneous injection have remained essentially the same.
First used in 1853
Nowadays, several medical conditions are treated with self-injected therapies. Yet, syringes were originally designed for administration by healthcare professionals. We thought about how this might impact our patients.
We sought to positively change the patient injection process for self-administration.
We set out to change the way biologic patients inject
To us, that meant taking a fresh look at the patient injection process. We wanted to develop a patient-centric device that utilized modern technology to help patients with their self-injection process.
To do that, we not only reevaluated how patients inject, but also considered how humans interact with technology today.
21st century ideation
Our relationship with today’s tech is almost entirely unrecognizable from two decades prior
We’ve come to expect things from our devices, and not just our smartphones. Even our thermostats and door locks are sending us live alerts. We expect our tech to be intelligent and automatic, yet simple and customizable.
For instance, some smart thermostats intelligently adjust the temperature based on our physical presence, yet instantaneously respond to input when we desire a different temperature.
Modern machines seek to find a balance, teetering between complete user control and thoughtful automation. The better the balance, the more we perceive our tech as intuitive.
Intuitive design, at its essence, is all about communication with the user
Simple cues signal when action is needed, and then automate the processes in between. Thoughtful design enables the user and device to coordinate, encouraging consistent and predictable interactions. With minimal exposure to technical complexities, the user is meant to feel in control of the device they’re wielding.
So, how can we apply today’s tech innovations to self injecting?
A Fresh Look at the Injection Process
Creating a modern experience
Our goal to update the injection procedure began with an examination of the patient’s perspective from start to finish. What do they need to know at each step of the process? And how can we create cues that help guide them through the injection process?
Guiding the Biologic Patient
This site is intended for healthcare professionals only. If you are not a healthcare professional, please contact your doctor about ENBREL.
Cue the lights and sounds of Enbrel Mini® with AutoTouch®
Once the patient is ready to start the injection process, how can we help prompt them to secure their medication cartridge in the device? We took inspiration from the familiar and used previously learned behaviors to help direct user action.
We’ve all come to know the familiar chime our car doors and refrigerators belt out when we’ve left the door open. Similarly, patients inserting their medication cartridge are prompted with a chime to secure the device’s door.
Shedding light on what's next
Once the cartridge is secured, automation is intended to keep patients on track with their injection process. The device automatically detects and identifies the cartridge inserted. Next, we needed to cue the patient to place the device at an appropriate injection site.
So, what does the patient see?
We thought lighting up the injection area could both improve visibility and help direct the user to position the device at the appropriate injection site. So, we included a guiding light at the bottom of the device to help illuminate this part of the process.
Light the injection site
Once the patient positions the device at an approved injection area, how does the device know the patient is ready to inject? We included smart sensors that detect contact with skin. When the patient holds the device on the injection site, the injection is ready to begin.
Press and go
We needed our device to communicate that the injection is ready for initiation. We’re all too aware that green means go and red means stop. And, sure enough, the autoinjector thumb button uses green lights to communicate that the injection is ready to begin, and red lights to signal an error.
At this point, patients can initiate their injection with the touch of a button.
Green means go
In today’s information age, where we track everything from pizza to packages, we knew it would be important to have a clear way to track injection progress as well.
Audible and visual cues signal that the injection is underway. These include chimes and a progress bar that tell the patient how far along they are in the administration of their medication.
A device that not only works for self-injecting patients, but works with them
Important Safety Information and Indications
Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.
In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients. The role of TNF blocker therapy in the development of malignancies is unknown.
Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.
In patients who initiated therapy at ≤18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (<0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
CONGESTIVE HEART FAILURE
Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.
Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.
HEPATITIS B REACTIVATION
Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.
Allergic reactions associated with administration of ENBREL during clinical trials have been reported in <2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.
Live vaccines should not be administered to patients on ENBREL. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, temporarily discontinue ENBREL and consider prophylactic treatment with Varicella Zoster Immune Globulin.
Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.
WEGENER’S GRANULOMATOSIS PATIENTS
The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.
MODERATE TO SEVERE ALCOHOLIC HEPATITIS
Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.
The most commonly reported adverse reactions in RA clinical trials were injection site reaction and infection. In clinical trials of all other adult indications, adverse reactions were similar to those reported in RA clinical trials.
In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.
The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
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.
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.