Evaluating the Efficacy and Risks of Biologics for Ankylosing Spondylitis

Biologics (additional inquiries)

The questions below, starting with an asterisk, were previously asked to Dr.
Tseng, and I appreciate Dr.
Tseng's response on January 25: "It is effective, and I recommend continuing the medication and adjusting the dosage after some time." I would like to ask the doctor a follow-up question: The biological agent costs 400,000 NTD per year out of pocket, which is a significant burden for my family.
However, I am willing to bear this cost if it can make my child healthier.
My current concern is that the severe side effects of continuing the maximum dosage of Celebrex include cardiovascular issues and gastrointestinal diseases, while the severe side effects of biological agents include infections and malignancies (although the incidence of these severe side effects for both Celebrex and biological agents is quite low).
Additionally, it seems that biological agents can lower the current CRP of 0.3 and ESR of 12 even further.
So, can using biological agents make my child healthier compared to taking Celebrex?
*My son is currently 18 years old and started showing symptoms of ankylosing spondylitis two years ago, with a diagnosis made one year ago.
May I ask: 1) For the past six months, my son has been taking two capsules of Celebrex (200 mg packaging) daily, and his CRP has been maintained around 0.3 mg/dL, ESR around 12, and he has not experienced any pain (previously, he only had pain in the sacroiliac joint; during the first MRI, no other spinal joints showed inflammation, only the sacroiliac joint was inflamed).
His X-rays have not worsened, but if he reduces the dosage to one capsule daily, his levels will rise after a month (CRP around 0.7, ESR around 20), and the pain will return.
He had previously taken Indomethacin when first diagnosed, but it did not effectively control the inflammation levels or pain.
Is taking Celebrex in this manner considered effective treatment? Should he continue taking Celebrex? (Note: Before starting medication treatment, his CRP was around 1.7 and ESR around 38.)

Hao, 40~49 year old female. Ask Date: 2022/01/26

Dr. Zeng Guosen reply Internal Medicine

Hello, the medical guidelines suggest a sequence of medications for treatment, taking into account their side effects and benefits.
The principle is to use anti-inflammatory and analgesic medications as the first line of treatment.
The consideration of biologics should be discussed with a physician to determine what is best for the child.
With a CRP of 0.3 and an ESR of 12, both values are within normal range, and there is no need to lower them further.
At this point, the focus should be on evaluating symptoms and whether the X-rays are stable.
Thank you.

Reply Date: 2022/01/26

More Info

When evaluating the efficacy and risks of biologics for Ankylosing Spondylitis (AS), it is essential to consider both the benefits and potential side effects associated with these treatments. Your situation, particularly regarding the financial burden of biologics and the current management of your child's condition with Salazopyrin (Sulfasalazine), is a common concern among patients and their families.

Efficacy of Biologics
Biologics, such as TNF inhibitors (e.g., Adalimumab, Infliximab) and IL-17 inhibitors (e.g., Secukinumab), have been shown to be effective in managing symptoms of AS. They can significantly reduce inflammation, improve physical function, and enhance the quality of life for patients. In clinical studies, these medications have demonstrated the ability to lower C-reactive protein (CRP) levels and improve the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which measures disease activity.

In your child's case, maintaining CRP levels around 0.3 mg/dL and ESR at 12 with Salazopyrin indicates that the medication is effectively controlling inflammation. The fact that symptoms return upon reducing the dosage suggests that Salazopyrin is providing a therapeutic benefit, albeit with the need for a higher dose to maintain control.

Risks of Biologics vs. Traditional Medications
While biologics can be very effective, they come with their own set of risks. The most significant concerns include:
1. Infection Risk: Biologics can suppress the immune system, increasing the risk of serious infections. Patients must be monitored closely for signs of infection, and vaccinations should be up to date before starting treatment.

2. Malignancy Risk: There is a potential, albeit small, risk of developing certain types of cancer, particularly lymphomas, associated with long-term use of biologics.

3. Cost: As you mentioned, the financial burden of biologics can be substantial, averaging around $40,000 per year. This is a significant consideration, especially if the benefits are not guaranteed.

On the other hand, Salazopyrin, while effective for many patients, can also have side effects, including gastrointestinal issues and potential impacts on liver and kidney function. Long-term use of Salazopyrin may also carry cardiovascular risks, particularly in patients with pre-existing conditions.

Decision-Making
Given your child's current stability on Salazopyrin, it is reasonable to continue this treatment while monitoring for any side effects. If symptoms worsen or if there is a significant increase in inflammatory markers, a switch to biologics may be warranted.
In terms of whether biologics would provide a healthier alternative compared to continuing Salazopyrin, it largely depends on individual response and tolerance. Some patients may find that biologics offer better control of their disease with fewer side effects, while others may do well on traditional DMARDs like Salazopyrin.

Conclusion
In summary, the decision to switch to biologics should be made in consultation with your healthcare provider, weighing the current effectiveness of Salazopyrin against the potential benefits and risks of biologics. It may also be beneficial to consider a trial period of biologics if your child's condition changes or worsens, while keeping a close eye on any side effects. Regular follow-ups and monitoring of inflammatory markers will be crucial in managing your child's AS effectively.

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