Biologics for Ankylosing Spondylitis: Key Questions Answered

Biologics

Hello, doctor.
My son is 18.7 years old and is a patient with ankylosing spondylitis.
I would like to ask some questions regarding biologic agents: To save the doctor's time, I would like to define the following conditions as "Condition A" (the prescription of anti-inflammatory and analgesic medications for three months in the same institution requires that at least two non-steroidal anti-inflammatory drugs (NSAIDs) have been used for adequate treatment, but with insufficient efficacy.
There must be two consecutive checks showing BASDAI > 6, ESR > 28 mm/hr, and CRP > 1 mg/dL, with an interval of at least 4 weeks of adequate treatment between the two checks).
Condition A is one of the many conditions I found online regarding the application for public funding for biologic agents.
My questions are as follows:
1) If the application for public funding for biologic agents is approved and treatment is initiated, will the treatment be stopped once the inflammatory markers return to normal and there is no pain?
2) After stopping the treatment, if the inflammatory markers rise again and pain returns, will Condition A need to be re-evaluated for another application for public funding for biologic agents?
3) If my son directly pays out of pocket for biologic agents and after some time feels that the cost is unaffordable, can he still apply for public funding for biologic agents? Will having previously paid out of pocket make it more difficult to get approval for public funding?
4) Biologic agents have specified administration schedules, for example, Humira is administered once every four weeks, and Enbrel is administered twice a week.
Are there cases where patients who are not very severe but still require treatment can extend these administration intervals, such as administering Enbrel once every two weeks?
5) The biologic agents suitable for ankylosing spondylitis seem to be primarily Enbrel, Remicade, and Humira.
Although Enbrel is suitable for pediatric use, its schedule of twice a week would be very inconvenient for my son (he would often have to skip classes).
Additionally, Remicade and Humira have disclaimers stating that "the safety and efficacy in pediatric patients have not been established." I would like to ask the doctor for advice; my son is 18.7 years old and can be considered an adult, but the human body structure does not change completely at 17.9 years (child) and 18 years (adult).
I am unsure how to convince myself to allow my newly adult son to receive Remicade or Humira.
Could the doctor provide some guidance? Thank you.

Jie, 10~19 year old female. Ask Date: 2022/02/17

Dr. Gao Jiankai reply Internal Medicine

Hello, thank you for your questions.
There are many inquiries, so I can only provide brief responses as follows:
1) If you apply for public funding to receive biologic therapy and it is approved, after a period of treatment, if the inflammatory markers normalize and there is no pain, will the treatment be stopped? --> If the treatment continues for more than two years and symptoms improve, the review committee of the National Health Insurance may suggest that the prescribing physician reduce or discontinue the medication.
2) After stopping the treatment, if the inflammatory markers rise again and pain occurs, if you want to reapply for public funding for biologics, will the process need to be repeated? --> The process will be simpler and not entirely the same; in principle, patients whose condition worsens will be prioritized for treatment.
3) If my son directly pays out of pocket for biologic therapy and after some time finds the cost burdensome, can he still apply for public funding for biologics? Will having previously paid out of pocket make it harder to get approval for public funding? --> He can apply for public funding, but he will need to go through the application process.
4) Biologics have specific administration schedules, for example, Humira is administered once every four weeks, and Enbrel is administered twice a week.
Are there cases where patients who are not severely ill but still require treatment can extend these administration intervals, such as administering Enbrel once every two weeks? --> Yes, this can be determined by your physician.
When the review physician from the National Health Insurance suggests that the prescribing physician reduce the dosage, the physician may also adjust the frequency of administration.
5) The biologics suitable for ankylosing spondylitis seem to be Enbrel, Remicade, and Humira.
Although Enbrel is suitable for children, its administration of twice a week is inconvenient for my son (he often has to skip classes).
Additionally, the package inserts for Remicade and Humira mention that "the safety and efficacy in pediatric patients have not been established." I would like to ask the doctor, my son is 18.7 years old, which can be considered as an adult, but the human body structure cannot be completely different between 17.9 years (child) and 18 years (adult).
I am unsure how to convince myself to allow my newly adult son to receive Remicade or Humira.
Could the doctor provide some advice? Thank you.
--> Current injection designs have advanced significantly, and the pain associated with administration is minimal; many patients self-administer.
The nurses for each medication are very experienced and provide a lot of support.
However, if your son’s symptoms are mild, perhaps oral medication would suffice.
The Allergy, Immunology, and Rheumatology Department of Changhua Hospital, Ministry of Health and Welfare, is concerned about you.

Reply Date: 2022/02/17

More Info

Understanding biologics for Ankylosing Spondylitis (AS) is crucial for managing this chronic inflammatory disease effectively. Your questions reflect a deep concern for your son's treatment options, and I will address each of them comprehensively.

1. Discontinuation of Biologics: If your son qualifies for public funding for biologics and experiences a significant reduction in inflammation markers (such as ESR and CRP) and pain, the treating physician may consider discontinuing the treatment. However, this decision is typically made on a case-by-case basis. It is essential to monitor the patient's condition closely, as stopping treatment can lead to a resurgence of symptoms. The goal is to maintain remission while minimizing medication use.

2. Reapplying for Biologics: If your son stops the biologic treatment and later experiences a flare-up with elevated inflammatory markers, he may need to reapply for public funding. The criteria you mentioned (A) would likely need to be met again, as they ensure that the treatment is necessary and that other options have been exhausted. This process can be frustrating, but it is designed to ensure that biologics are used appropriately.

3. Switching from Self-Pay to Public Funding: If your son initially self-pays for biologics and later finds the cost burdensome, he can apply for public funding. However, the transition may not be straightforward. The healthcare provider will need to document the necessity of the treatment and the reasons for the switch. While having previously self-paid may not disqualify him, it could complicate the application process, as the healthcare system may require evidence that the treatment was necessary and effective.

4. Adjusting Treatment Intervals: Biologics do have recommended dosing schedules, but in some cases, physicians may adjust these intervals based on the patient's response to treatment. For example, if a patient is stable and has low disease activity, a physician might consider extending the interval between doses. However, this should only be done under the guidance of a healthcare provider, as it requires careful monitoring of the patient's condition.

5. Choosing the Right Biologic: The choice of biologic is indeed critical, especially for younger patients. While Enbrel (Etanercept) is approved for pediatric use and is effective, the dosing schedule can be inconvenient for a student. On the other hand, Remicade (Infliximab) and Humira (Adalimumab) have different dosing regimens that might be more manageable. The concern regarding the safety and efficacy of these medications in patients just above the pediatric age threshold is valid. It is essential to discuss these concerns with your son's rheumatologist, who can provide insights based on the latest research and clinical experience. They can help weigh the risks and benefits of each option, considering your son's specific situation and lifestyle.

In summary, managing Ankylosing Spondylitis with biologics involves careful consideration of treatment protocols, monitoring of disease activity, and open communication with healthcare providers. It is essential to work closely with your son's rheumatologist to navigate these decisions, ensuring that he receives the most appropriate and effective care while minimizing disruptions to his daily life.

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