Assessing Long-Term Risks of Biologics vs. Traditional Treatments

Biologics (Follow-up Question)

Dear Dr.
Gao,
Below the asterisks is the question I raised on January 17.
I appreciate your detailed response, and I would like to ask a few more questions:
1) I want to focus on the long-term severe (or life-threatening) side effects.
The long-term severe (or life-threatening) side effects of Secukinumab (Cosentyx) include cardiovascular, renal, and gastrointestinal issues.
For biologics, the long-term severe (or life-threatening) side effects include infections and malignancies (I found a study online from Sweden suggesting that ankylosing spondylitis patients do not have the same risk of lymphoma as those with rheumatoid arthritis).
To ensure my son maintains a healthier body, I am willing to spend 400,000 NTD annually on biologics, but I am concerned it may not be that simple.
I would like to ask if, regarding long-term severe (or life-threatening) side effects, the health risks posed by biologics are significantly lower than those of Secukinumab?
2) If the risks are significantly lower, and my son does not experience short-term side effects (such as fatigue, headache, nausea, etc.) from biologics, similar to how he currently tolerates Secukinumab, should we consider self-paying for biologics to achieve a healthier body? Or am I being too simplistic (naive) in thinking that biologics are as beneficial as I imagine?
3) In terms of efficacy, do biologics provide a better chance of achieving a period of remission or reduced dosage compared to anti-inflammatory pain medications? (Although neither treatment can cure ankylosing spondylitis, I often see reports online suggesting that patients can stop medications after a certain period.)
4) If we decide to self-pay for biologics, can the first dose be administered during the initial outpatient visit?
5) After that, will each dose require a return visit to the outpatient clinic, or can it be administered directly at a hospital infusion center? (Since my son's class schedule is fixed, it is inconvenient for him to visit the outpatient clinic weekly.)
6) If he needs to switch hospitals due to a job change, will the new hospital reassess him before administering the treatment, or can he use the relevant documentation from the original hospital to receive the treatment directly?
*My son is currently 18 years old.
He began experiencing symptoms of ankylosing spondylitis two years ago and was diagnosed a year ago.
For the past six months, as long as he takes two Secukinumab (200 mg) capsules daily, his CRP levels are controlled around 0.3 mg/dL, ESR around 12, and he has no pain (previously, he only experienced pain in the sacroiliac joints).
His X-rays have not worsened, but if he reduces to one capsule daily, his levels rise after a month (CRP around 0.7, ESR around 20), and the pain returns.
Six months ago, he tried Etanercept (Enbrel), but it did not adequately control his inflammatory markers or pain.
Should we consider self-paying for biologics? (If financially feasible), because I am concerned that taking the maximum dose of Secukinumab daily may have long-term vascular and renal side effects.
However, I am also worried about the risks of tumors and infections associated with biologics.
--> I do not recommend it.
While biologics can improve the disease course, they are not "curative" medications and come with more potential side effects that require caution.
I typically reserve them for patients with more severe conditions.
Currently, your child's condition is manageable, and he likely does not need them yet.
(Original question number 177678)

Yong, 40~49 year old female. Ask Date: 2022/01/27

Dr. Gao Jiankai reply Internal Medicine

Hello, thank you for your inquiry.
Here is my consolidated response:
1) I would like to focus on the long-term severe (or fatal) side effects.
The long-term severe (or fatal) side effects of Celebrex (celecoxib) include cardiovascular, renal, and gastrointestinal issues.
The long-term severe (or fatal) side effects of biologics include infections and malignancies (it seems there is research in Sweden indicating that patients with ankylosing spondylitis do not develop lymphoma like those with rheumatoid arthritis).
To ensure my son maintains better health, I am willing to spend 400,000 NTD annually out-of-pocket for biologics, but I am concerned that it may not be that straightforward.
I would like to ask the physician if, regarding long-term severe (or fatal) side effects, the health risks posed by biologics are significantly lower than those of Celebrex? --> I believe biologics are new medications with potentially more unpredictable side effects, and it would be better to use them in patients with more difficult-to-control conditions.
For milder conditions, using anti-inflammatory pain relievers, such as NSAIDs and regular exercise, can achieve good therapeutic results.
After improvement, it is also possible to reduce the use of anti-inflammatory medications, with opportunities for tapering or discontinuation in the future.
2) If the risks are significantly lower, and my son does not experience short-term side effects (fatigue, headache, nausea, etc.) from biologics as he currently does with Celebrex, can we consider out-of-pocket biologics for better health? Or am I being too simplistic (naive) in thinking that biologics are as good as I imagine? --> As mentioned above, biologics are still medications that have a greater immunosuppressive effect.
For patients with milder conditions, using biologics may be considered overkill and could pose relatively higher risks.
3) In terms of efficacy, do biologics provide a better chance of tapering or discontinuing medication after a period compared to anti-inflammatory pain relievers? (Although neither treatment can cure ankylosing spondylitis, I often see reports online suggesting that medication can be discontinued after a certain period.) --> If ankylosing spondylitis is well-controlled, there is always a chance to discontinue medication in the future, regardless of whether biologics or traditional medications are used.
However, there is no comparison regarding whether the type of medication affects the likelihood or speed of future discontinuation.
4) If I choose to pay out-of-pocket for biologics, can I receive the first injection during the initial outpatient visit? --> Whether you can receive biologics depends on whether the hospital has the specific biologic you wish to receive.
Therefore, if you want to pay out-of-pocket for a specific biologic, please be sure to contact the hospital's service desk to confirm the availability of the desired biologic before deciding to make an appointment.
If the medication is available and a physician can prescribe it, you can receive the injection on the same day.
5) After that, will I need to return to the outpatient clinic for each injection, or can I go directly to an infusion center? (Because my son has a fixed class schedule and it is inconvenient to visit the outpatient clinic weekly.) --> As mentioned, you must return to the outpatient clinic for a physician to prescribe the medication, even if you are paying out-of-pocket.

6) If I need to switch hospitals due to a job change, will the new hospital reassess before administering the injection, or can I use the relevant documentation from the original hospital to receive treatment directly? --> As long as you are paying out-of-pocket and the new hospital has the medication, you can ask the physician for assistance in prescribing it.
The more complicated situation arises with National Health Insurance prescriptions, as you cannot switch hospitals for treatment.
Best regards from the Allergy, Immunology, and Rheumatology Department of Changhua Hospital, Ministry of Health and Welfare.

Reply Date: 2022/01/27

More Info

When considering the long-term risks of biologics versus traditional treatments like NSAIDs (non-steroidal anti-inflammatory drugs) such as Celecoxib (the active ingredient in "希樂葆"), it is essential to weigh the benefits and potential serious side effects of each treatment option.
1. Long-Term Serious Side Effects: Traditional NSAIDs, while effective for managing pain and inflammation, can lead to significant long-term side effects, particularly concerning cardiovascular health, renal function, and gastrointestinal issues. Chronic use of NSAIDs can increase the risk of heart attack, stroke, kidney damage, and gastrointestinal bleeding. In contrast, biologics, which are often used to treat autoimmune conditions like ankylosing spondylitis, have their own set of risks. The most notable long-term risks associated with biologics include increased susceptibility to infections and a potential heightened risk of malignancies, such as lymphoma. However, studies, including those from Sweden, suggest that the risk of lymphoma in patients with ankylosing spondylitis treated with biologics may not be as pronounced as in those with rheumatoid arthritis.

2. Risk Assessment: If the long-term risks of biologics are indeed lower than those associated with prolonged NSAID use, and if your son is not experiencing significant short-term side effects from biologics (such as fatigue, headache, or nausea), it may be reasonable to consider switching to biologics for better disease management. However, it is crucial to remember that biologics are not a cure; they are designed to manage symptoms and slow disease progression. The decision should be made in consultation with a rheumatologist who can evaluate the specific risks and benefits based on your son's health status.

3. Effectiveness: Biologics can often provide more effective long-term control of inflammation compared to traditional NSAIDs. Many patients find that they can reduce or even discontinue NSAIDs while maintaining disease control on biologics. However, this varies from patient to patient, and the effectiveness of treatment should be monitored regularly.

4. Administration of Biologics: Typically, the first dose of a biologic can be administered in a clinic setting, and subsequent doses may also be given there or at an infusion center, depending on the specific medication and the healthcare provider's protocols. It is essential to discuss the logistics of treatment with your healthcare provider to ensure that it fits within your son's schedule.

5. Switching Providers: If you need to change hospitals or clinics, it is generally possible to transfer care. Most healthcare providers will require a reassessment, especially if there is a change in treatment. Having documentation from the previous provider can facilitate this process, but a new evaluation is often necessary to ensure the treatment plan is still appropriate.

In conclusion, while both biologics and traditional NSAIDs have their risks, the choice of treatment should be individualized based on your son's current health status, the severity of his condition, and his response to previous treatments. It is advisable to have a thorough discussion with a rheumatologist to explore the best treatment options and to monitor for any potential side effects associated with long-term use of either treatment.

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