Addressing Challenges of Self-Injectable Disease-Modifying Therapies in Patients With Multiple Sclerosis

While the use of oral DMTs has steadily increased among MS patients since the first of these agents was approved by the US Food and Drug Administration (FDA) in 2010, injectable DMTs remain a common treatment strategy with a well-established safety profile in MS.^1,2 Patients may initially experience challenges in starting or transitioning to a self-administered injectable DMT; to overcome these issues, health care providers must be prepared to address numerous factors that arise when developing a customized treatment approach for each patient.
 
Robert Bermel, MD, a staff neurologist at the Neurological Institute’s Mellen Center for Multiple Sclerosis at Cleveland Clinic in Ohio, shared insights and clinical recommendations regarding the prescription of self-injectable DMTs in MS. At the Mellen Center, Dr Bermel provides patient care, conducts research, and leads the implementation and application of optical coherence tomography (OCT). His research explores advanced imaging techniques, including OCT, diffusion tensor magnetic resonance imaging (DTI), and functional magnetic resonance imaging (MRI).

What considerations must be taken when switching a patient with MS from an oral DMT to an injectable DMT?

There are several important considerations when switching a patient with MS from an oral DMT to an injectable DMT:

Efficacy: The injectable DMT should be as or more effective than the oral DMT in reducing the frequency and severity of MS attacks and in slowing the progression of the disease.
Safety: The injectable DMT should have an acceptable safety profile that fits the patient’s health history and personal risk tolerance.
Patient preference: It is important to consider the patient’s preferences and willingness to switch to an injectable DMT; some patients may prefer the convenience of taking a pill, while others may prefer the potential for improved efficacy with an injectable DMT.
Cost: The cost of the injectable DMT should be taken into account, and any available patient copay assistance or free drug programs may need to be switched or applied for as well.
Administration: The patient should be able to easily self-administer the injectable DMT or have access to someone who can assist with the injections.
Monitoring: The patient’s response to the injectable DMT should be closely monitored by their health care provider to ensure it is effective and well-tolerated.
Dosing frequency: The injectable DMT may have a different dosing frequency than the oral DMT, which may require education or a reminder system in order to ensure adherence to the schedule.
Timing of switch and acquisition of interval baseline blood tests or imaging: Adverse effects of an oral DMT can be the cause of the switch; if that is the case, then a provider may opt for a washout interval for liver function tests or blood count levels to normalize before starting a new DMT, though this runs the risk of breakthrough disease due to washout. At a minimum, acquiring new updated baseline blood tests and brain imaging may be appropriate to establish a starting point from which future monitoring can be compared.

What are some of the main challenges you encounter when prescribing DMTs that are self-administered in MS?

A challenge of note is patient adherence; for example, some patients may have difficulty remembering to take their medication as prescribed, which can lead to missed doses and suboptimal treatment outcomes.³

Difficulty administering the medication may also be an issue. Self-injection can be an intimidating prospect if a patient has not had experience with medical procedures, especially if they have a disability that limits their coordination; however, auto-injectors often make the injection much easier and less painful than previous generations of therapies. Injectable medications may also require storage and handling precautions. Additionally, some self-administered DMTs can cause side effects such as injection site reactions or flu-like symptoms, which may be unpleasant for patients.³

Cost may pose a barrier for some patients, as self-administered DMTs can be expensive. However, coverage is often good for approved DMTs, and copay assistance programs can help offset out-of-pocket costs.

Access to care may affect patients who live in remote or underserved areas, as patients may have difficulty accessing health care providers who can provide the necessary training and support for self-administration of DMTs. Once trained, however, self-administered DMT provides a unique way to overcome access barriers, especially for those unable to travel to infusion centers for medication administration.

Patient preference may present a barrier, with some individuals expressing a preference for oral medications or a hesitance to self-administer injectable medications. Disease severity represents another potential barrier. Fortunately, there are self-administered DMT options even in the category of high efficacy therapies.

How does adherence to self-injectable DMTs affect patient outcomes, and what are some ways that you address adherence challenges in clinical practice?

Adherence to self-injectable DMTs is important for achieving optimal treatment outcomes in patients with MS. Adherence can be influenced by a variety of factors, such as a patient’s beliefs and attitudes towards their medication, the medication’s side effect profile, and the patient’s ability to self-administer the medication.³

Studies have shown that poor adherence to self-injectable DMTs is associated with a higher risk of relapse and a greater risk of disability progression in patients with MS. In contrast, strict adherence to self-injectable DMTs is associated with a lower risk of relapse and a slower progression of disability.^4,5

Providers may use the following strategies to address adherence challenges in clinical practice when prescribing self-injectable DMTs for MS:

• Educate patients about the importance of adherence and the potential consequences of nonadherence. This includes explaining how the DMT works to slow the progression of the disease and reduce the frequency and severity of MS attacks;

• Provide clear and detailed instructions for self-administration of the DMT, including how to prepare and administer the injection, how to dispose of needles and other equipment, and what to do in case of a missed dose. It is better when the instructions are clearer and more detailed;

• Encourage patients to keep a medication diary to track their adherence. This can help patients identify any barriers to adherence and address them with their health care provider;

• Provide support and assistance with self-administration as needed. This may include demonstrating the injection technique, providing guidance on injection site rotation, if necessary, and answering any questions or concerns the patient may have;

• Identify and address any barriers to adherence, such as cost or side effects. This may involve working with the patient’s insurance company to find an affordable DMT or discussing potential side effect management strategies with the patient; and

• Regularly monitor and assess adherence to ensure that it remains at an optimal level. This may involve regularly reviewing the patient’s medication diary and checking in with the patient to ensure they are taking their medication as prescribed.

Are there any specific patient counseling points you can share related to injection anxiety and technique?

To address injection anxiety and technique, health care providers can take the time to explain the injection process and address any concerns or fears the patient may have, demonstrate the injection technique using a model or other teaching aid, and encourage the patient to practice the injection technique using these methods before self-administering the DMT. Clinicians should also provide support and encouragement to the patient during the injection process and offer suggestions for relaxation techniques, such as deep breathing or visualization, to help the patient feel more comfortable during injections.

What is the role of nurses, medical social workers, and other allied health care providers in educating patients with MS about self-injection techniques? What barriers might be encountered in this setting, and what role can telehealth play? 

Nurses, medical social workers, and other allied health care providers play a crucial role in educating patients with MS about self-injection techniques. These health care professionals are responsible for providing information and instruction on the proper use of self-injection devices as well as helping patients develop a plan for administering their medications on their own.

A potential barrier that may be encountered in this setting is a lack of understanding or knowledge about the medication and how it works. It is important for health care professionals to provide clear and concise information about the medication, including its purpose, dosage, and potential side effects. Fear or anxiety about self-injecting is another potential issue. Some patients may be afraid of needles or may be anxious about administering their own injections.^6,7 It is important for health care professionals to provide emotional support and reassurance to help patients feel more comfortable with the process.

In addition, some patients may have difficulty manipulating the injection device due to physical limitations or mobility issues. In these cases, health care professionals may need to provide further instruction or assistance to help patients effectively self-inject.

Telehealth can play a role in educating patients about self-injection techniques by providing an additional platform for health care professionals to interact with patients and to offer guidance and support. Telehealth can also be useful for patients who live in remote areas or have difficulty accessing in-person health care services.

What are your recommendations for clinicians on increasing and monitoring the effectiveness of these educational efforts?

Clinicians interested in increasing and monitoring the effectiveness of educational efforts for patients with MS who are using self-injection techniques should use a variety of teaching methods, as different patients may respond better to different teaching methods. Using a combination of teaching methods, such as visual aids, hands-on demonstrations, and written instructions, can help ensure that all patients have a clear understanding of the self-injection process.

Clinicians should encourage patients to ask questions and raise any concerns they may have about self-injection; this can help identify any misunderstandings or areas where further education is needed. Because self-injection can be a new and challenging task for some patients, providing ongoing support and reinforcement can also help patients feel more confident and comfortable with the process.

Encouraging patients to provide feedback on the effectiveness of the educational efforts can help identify any areas where additional education is needed or where the teaching methods can be improved.

Which questions would you like to see explored in future research pertaining to patient education for self-administered injectables in MS?

There are numerous questions that could be investigated in future research on this topic: How can health care professionals best support patients in developing the skills and confidence needed to self-administer injectables? What are the most effective methods for educating patients about self-administered injectables, and how can these methods be tailored to meet the needs of individual patients? How can telehealth be used effectively to support patient education for self-administered injectables, and what are the most effective telehealth platforms and approaches for this purpose? What impact do patient education programs have on medication adherence and health outcomes for patients with MS who are using self-administered injectables? How can health care professionals best address and overcome barriers to patient education for self-administered injectables, such as fear or anxiety about needles, difficulties with manual dexterity, or lack of understanding about the medication?
 
Exploring these questions through research could help to improve patient education programs and ultimately enhance care and outcomes for patients with MS who are using self-administered injectables.

This Q&A was edited for clarity and length.

Disclosures

Robert Bermel, MD, reported affiliations with AstraZeneca Pharmaceuticals, LP; Biogen, Inc; EMD Serono, Inc; Genzyme Corp/Sanofi-Aventis US LLC; Genentech, Inc/Roche; Labcorp; Eli Lilly & Co; Novartis Pharmaceuticals Corp; Qr8 Health; TG Therapeutics, Inc; and Horizon Therapeutics plc.

References

1. Goldschmidt C, McGinley MP. Advances in the treatment of multiple sclerosis. Neurol Clin. 2021;39(1):21-33. doi:10.1016/j.ncl.2020.09.002
 
2. D’Amico E, Zanghì A, Avolio C. Injectable versus oral first-line multiple sclerosis therapies: knows and unknowns from observational studies. Neural Regen Res. 2022;17(3):567-568. doi:10.4103/1673-5374.320985
 
3. Kołtuniuk A, Rosińczuk J. Adherence to disease-modifying therapies in patients with multiple sclerosis. Patient Prefer. Adherence. 2018;12:1557-1566. doi:10.2147/PPA.S175095
 
4. Kołtuniuk A, Pytel A, Krówczyńska D, Chojdak-Łukasiewicz J. The quality of life and medication adherence in patients with multiple sclerosis—cross-sectional study. Int J Environ Res Public Health. 2022;19(21):14549. doi:10.3390/ijerph192114549
 
5. Burks J, Marshall TS, Ye X. Adherence to disease-modifying therapies and its impact on relapse, health resource utilization, and costs among patients with multiple sclerosis. Clinicoecon Outcomes Res. 2017;9:251-260. doi:10.2147/CEOR.S130334
 
6. Coyne M, Rinaldi A, Brigham K, et al. Impact of routines and rituals on burden of treatment, patient training, cognitive load, and anxiety in self-injected biologic therapy. Patient Prefer Adherence. 2022;16:2593-2607. doi:10.2147/PPA.S375037
 
7. de Ceuninck van Capelle A, van der Meide H, Vosman FJH, Visser LH. A qualitative study assessing patient perspectives in the process of decision-making on disease modifying therapies (DMT’s) in multiple sclerosis (MS). PLOS One. 2017;12(8):e0182806. doi:10.1371/journal.pone.0182806

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