Major findings

Fingolimod has been shown to lower the number of relapses in multiple sclerosis (MS) patients and slow down disease progression. However, fingolimod can also cause a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.

Reasons for Side Effects

Fingolimod works by inhibiting the circulation of lymphocytes. Lymphocytes are one of the cells that make up the immune system and are involved in the immune response that causes MS. Fingolimod is expected to slow down the worsening of MS symptoms or reduce relapses by preventing lymphocytes from entering the bloodstream from lymph nodes. However, inhibiting the circulation of lymphocytes can increase the risk of infections and other side effects.

Common Side Effects

Liver dysfunction

Fingolimod can affect the liver. In the FREEDOMS trial, liver dysfunction was observed in about 10% of patients who took fingolimod.

Infections

Fingolimod can increase the risk of infections because it suppresses the immune system. In the FREEDOMS trial, infections were observed in about 20% of patients who took fingolimod.

Skin side effects

Fingolimod can affect the skin. In the FREEDOMS trial, about 10% of patients who took fingolimod experienced side effects such as skin rash and eczema.

Other side effects

Fingolimod can cause side effects such as headache, fatigue, and indigestion.

Side Effect Countermeasures

Liver dysfunction

If you experience symptoms of liver dysfunction, you should stop taking fingolimod and consult your doctor.

Infections

If you experience symptoms of infection, you should stop taking fingolimod and consult your doctor.

Skin side effects

If you experience symptoms of skin side effects, you should stop taking fingolimod and consult your doctor.

Other side effects

If you experience other side effects, consult your doctor.

Comparison between studies

Common points of studies

Several studies have shown that fingolimod is effective in reducing relapses in MS patients and slowing disease progression.

Differences in studies

The dosage of fingolimod used in each study and the characteristics of the patients involved differ. Therefore, it may be difficult to directly compare the results of the studies.

Precautions for Application to Real Life

Fingolimod is an effective drug for the treatment of MS patients, but it is important to be aware of the risk of side effects. Before taking fingolimod, it is important to consult your doctor to understand your symptoms and risks.

Limitations of current research

This study was based on individual patient data from the FREEDOMS trial. Therefore, it is unclear whether the results of this study can be applied to other studies or other MS patients.

Future research directions

It is necessary to further investigate the side effects of fingolimod and develop methods to reduce side effects.

Conclusion

Fingolimod is an effective drug for the treatment of MS patients, but it is important to be aware of the risk of side effects. Before taking fingolimod, it is important to consult your doctor to understand your symptoms and risks.