Quality of Life for MS Patients: The Role of Disease-Modifying Treatments (Part Two in Series)
In Part One, Quality of Life for MS Patients: Is it Health-Related?, we outlined four aspects to quality of life which include clinical health, role-performance, adaptability, and well-being. However, not one commenter mentioned disability in relation to Quality of Life. The overwhelming response was that we want to feel productive, to use our skills to pursue meaningful work, to enjoy simple pleasures, and to gain a satisfying sense of accomplishment. And as Sherry points out, we cannot beat “Father Time.”
Since multiple sclerosis is a chronic, progressive disease which has no cure, chemical treatments are aimed at controlling the symptoms and slowing the progression of the disease. I say chemical simply because a nutritional approach to symptom- and disease-management is beyond the scope of this brief post.
What are Disease-Modifying Treatments?
During the past 15 years, disease-modifying agents (aka DMDs) have been developed for use in the treatment of multiple sclerosis (MS). Basic goals of disease-modifying treatments for MS are to decrease central nervous system inflammation, reduce relapse rates, slow disability and the accumulation of cognitive dysfunction, reduce new lesion formation and the progression of brain atrophy, and improve a patient’s Health-Related Quality of Life (HRQOL).
Currently there are six FDA-approved disease-modifying agents for MS which include interferon beta-1a (Avonex and Rebif), interferon beta-1b (Betaseron), glatiramer acetate (Copaxone), natalizumab (Tysabri) and mitoxantrone (Novantrone). There are also a number of disease-modifying agents which are in clinical trials, including laquinimod, fingolimod, alemtuzumab, daclizumab, cyclophosphamide, teriflunomide, and cladribine.
In The Importance of Early Diagnosis of Multiple Sclerosis by James R. Miller, MD., found in the Supplement to Journal of Managed Care Pharmacy June 2004; 10(3):S4-S11, three significant trials are discussed in relationship to early treatment in MS.
1. Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study [CHAMPS] - Results from this study show that early treatment delayed or prevented Clinically Definite MS and reduced the frequency of new lesions. The probability of developing Clinically Definite MS were 44% lower in patients who received Avonex, and at 18 months, there were 58% fewer new or enlarging lesions and 71% fewer Gd+ lesions in patients who received treatment than in those who received placebo.
2. Early Treatment of Multiple Sclerosis [ETOMS] - Over 2 years, 24% fewer patients who received treatment developed Clinically Definite MS than those who received placebo. Annual relapse rates were lessened in the treatment group as were the number and volume of T2 lesions seen on MRI as compared to the placebo group.
3. Prevention of Relapses and Disability by Interferon-beta-1a Subcutaneously in Multiple Sclerosis [PRISMS] - Parallel groups of patients either received Rebif (22-mcg or 44-mcg) or a placebo for 2 years after which those on placebo were switched to Rebif for another 2 years. After 4 years, the crossover groups had greater increases in EDSS, and disease burden was progressively higher than in groups who received continuous treatment. Those patients for whom treatment is delayed do not see the same benefits as those who began treatment early. “What was lost cannot be regained.”
So why doesn’t every MS patient take advantage of the DMDs to delay the accumulation of disability and thus protect their Quality of Life?
Disease-modifying agents provide great benefit to the MS patient but potentially come with undesirable side-effects such as fatigue, flu-like symptoms, depression, headaches, and injection site reactions. There may also be a lack of efficacy (no single DMD works for every patient) in which case the patient either tries another treatment or decides to go without.
The decision to use a DMD requires a balance of risk/reward. If the side-effects are so great that Quality of Life is negatively impacted, then you may decide to go without. I’ve known patients who made this decision and found themselves feeling much better without medication. Personally, I am seeing more benefit than risk in the use of my DMD of choice and plan to stick with the treatment plan for now.
We cannot, however, disregard the impact of financial stressors, including the cost of disease-modifying drugs, on the patient’s Quality of Life. With rising healthcare costs and increased cost-sharing (ie. Tier 4 copays), a patient may find themselves unable to access one of the DMDs, an issue we will discuss in more detail in a later post.
When I think of the impact of DMDs on MY Quality of Life, I must have faith that their use is allowing me to pursue meaningful work and to enjoy simple pleasures for an increased period of time. Since I can’t conduct my own clinical trial within my own body, comparing drug versus placebo, I must rely upon the research conducted on my behalf and for all of us living with multiple sclerosis. As you will see in future posts, the use of disease-modifying treatments is but one approach to protecting and increasing the MS patient’s Health-Related Quality of Life.
Do the use of disease-modifying treatments positively or negatively impact upon your Quality of Life? Please share your story and opinions on the matter. Why do you choose to use a DMD or choose NOT to use a DMD? How has your decision impacted upon your perceived Quality of Life?