Main Research Findings

Hyaluronidase is an enzyme that is used in subcutaneous formulations (eg, RITUXAN HYCELA [rituximab and hyaluronidase human], HERCEPTIN HYLECTA [trastuzumab and hyaluronidase-oysk], PHESGO [pertuzumab/trastuzumab/hyaluronidase-zzxf], and Darzalex FASPRO [daratumumab and hyaluronidase-fihj]) to increase the dispersion and absorption of coadministered therapeutics. 2 A study was conducted to investigate the safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of recombinant human hyaluronidase PH20 (rHuPH20) administered intravenously in healthy volunteers. 2 The study found that intravenous administration of rHuPH20 was safe and well-tolerated, with PK/PD parameters within the expected range. 2 Deflazacort, a synthetic oxazoline derivative of prednisolone, has been suggested to have major advantages over other glucocorticoids, as it is claimed to cause fewer adverse effects at equivalent antiinflammatory potency. 1 A study comparing the pharmacodynamic effects of deflazacort and prednisolone in healthy subjects found that deflazacort exhibited similar anti-inflammatory effects to prednisolone with fewer adverse effects. 1

Benefits and Risks

Benefits Summary

Hyaluronidase is expected to increase the effectiveness of antibody drugs by promoting absorption in subcutaneous formulations. Deflazacort is believed to have fewer side effects than prednisolone while maintaining similar anti-inflammatory effects. These drugs are expected to expand treatment options for patients by each having unique advantages.

Risks Summary

Intravenous administration of hyaluronidase may raise safety concerns and requires careful administration. Deflazacort, like other steroid drugs, carries the risk of side effects. In particular, long-term administration may increase the risk of osteoporosis, cataracts, and infections.

Comparison between Studies

Commonalities of Studies

Both studies aimed to evaluate the effectiveness and safety of the drugs. They also share the commonality of being human-based studies.

Differences in Studies

The hyaluronidase study evaluated safety in intravenous administration, while the deflazacort study compared effectiveness and side effects with prednisolone. The drugs targeted also differed, with hyaluronidase being an enzyme and deflazacort being a steroid drug.

Consistency and Contradictions of Results

The hyaluronidase study found that intravenous administration was safe and well-tolerated, while the deflazacort study found that it had fewer side effects than prednisolone. Both studies suggest the effectiveness of their respective drugs, but they are studies evaluating different aspects of different drugs, so they cannot be simply compared.

Considerations for Real-Life Application

Hyaluronidase is expected to increase the effectiveness of antibody drugs by promoting absorption in subcutaneous formulations. However, as intravenous administration is a safety concern, care must be taken to avoid accidental intravenous administration. Deflazacort is believed to have fewer side effects than prednisolone, but long-term administration may increase the risk of side effects such as osteoporosis, cataracts, and infections. Therefore, it is important to follow the doctor's instructions and administer the medication appropriately.

Limitations of Current Research

The hyaluronidase study was conducted on healthy volunteers, so further research is needed for its application to patients. The deflazacort study focused on comparing it to prednisolone, and further research is needed on its comparison with other steroid drugs.

Future Research Directions

For the hyaluronidase study, it is important to conduct trials on patients to evaluate safety and effectiveness. For the deflazacort study, further research is needed to compare it with other steroid drugs and the risks of long-term administration.

Conclusion

Hyaluronidase and deflazacort are drugs with unique benefits, but there are also concerns about safety and side effects. When using these drugs appropriately, it is essential to follow the doctor's instructions and understand the risks of side effects before undergoing treatment. Further research on these drugs is expected to develop safer and more effective treatment methods.