Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar

Switching too a Biosimilar for Medical Reasons: A Case Study of Ulcerative Colitis

For patients with ulcerative colitis (UC) who experience adverse reactions to their prescribed medication,switching to a biosimilar may offer a viable solution. A recent case study from Saga University Hospital in Japan highlights the effectiveness and safety of this approach.

A 15-Year-Old’s Journey with UC

A 15-year-old girl was diagnosed with UC and initially treated with 5-aminosalicylic acid (5-ASA) and prednisolone. Despite initial betterment, her symptoms recurred. The patient progressed through a series of treatments, including vedolizumab, before ultimately receiving adalimumab, an anti-tumor necrosis factor (TNF) alpha biologic, to manage her condition.

After six weeks of adalimumab treatment, the patient’s UC symptoms were effectively controlled. However, she began experiencing redness, swelling, and itchiness at the injection site after the eighth dose. These reactions intensified with the ninth dose, prompting doctors to suspect an allergic reaction.

The Switch to a Biosimilar

Given the patient’s adverse reactions to the reference adalimumab, doctors switched her to adalimumab biosimilar LBAL. LBAL, manufactured by LG Chem, was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2021. Importantly, LBAL does not contain D-mannitol, an excipient present in the reference adalimumab, which is known to trigger injection site reactions in some patients.

“The safety of switching from anti-TNF originators to biosimilars for nonmedical reasons has been demonstrated in many studies,” the authors noted, “tho, vrey few studies have reported on switching to a biosimilar for medical reasons.”

Positive Outcomes and Future Considerations

For six months following the switch to LBAL,the patient experienced no injection site symptoms,and her UC remained stable. This case demonstrates that switching to a biosimilar for medical reasons, such as severe injection site reactions, can be a successful strategy for managing UC.

“Switching to a biosimilar for medical reasons may be an option under careful observation, considering that the originator and the biosimilar are not exactly the same,”

the authors concluded.

Key Takeaways

• Biosimilars can provide an effective alternative to reference biologic medications for patients experiencing adverse reactions.
• Switching to a biosimilar for medical reasons, such as injection site reactions, warrants careful consideration and monitoring.
• Understanding the specific differences between reference biologics and their biosimilars,including excipients,is crucial for personalized treatment decisions.

If you are experiencing unwanted side effects from your current UC treatment, discuss alternative options with your doctor. Biosimilars may offer a safe and effective solution for achieving long-term disease control.

What key differences between reference biologics and their biosimilars should healthcare providers be aware of when considering a switch for a UC patient?

Switching to Biosimilars for Medical Reasons: An Interview with Dr. Rina Patel

In the ever-evolving landscape of ulcerative colitis (UC) treatment, biosimilars are emerging as a viable option for patients experiencing adverse reactions to prescribed medications.We sat down with Dr. Rina Patel, a renowned gastroenterologist and UC specialist, to discuss a recent case study from Saga University Hospital in Japan, highlighting the efficacy and safety of switching to a biosimilar for medical reasons.

Dr. patel, first off, could you provide an overview of the case study and the patient’s journey with UC?

Certainly. The case study follows a 15-year-old girl diagnosed with UC, who initially responded well to 5-ASA and prednisolone but later experienced symptom recurrence. After trying vedolizumab, she was prescribed adalimumab, an anti-TNF biologic, which effectively controlled her UC symptoms. However, after eight weeks, she started experiencing injection site reactions that worsened with each dose.

What led the medical team to switch the patient to a biosimilar, specifically adalimumab biosimilar LBAL?

Given the severe allergic reactions and the likelihood that they were caused by D-mannitol, an excipient present in the reference adalimumab, the team decided to switch the patient to adalimumab biosimilar LBAL, which does not contain this excipient. This switch was made for medical reasons, as switching for non-medical reasons has been extensively studied and deemed safe.

How did the patient respond to the switch to LBAL, and what does this case study tell us about biosimilars and UC treatment?

The patient experienced no further injection site reactions for six months after switching to LBAL, demonstrating that biosimilars can indeed be a safe and effective alternative for patients experiencing adverse reactions to reference biologics. This case study suggests that switching to a biosimilar for medical reasons can be a successful strategy for managing UC, provided careful observation and consideration of the differences between reference biologics and their biosimilars.

What are some key takeaways from this case study that UC patients and healthcare providers should keep in mind?

Firstly, biosimilars can provide an effective alternative to reference biologics for patients experiencing adverse reactions. Secondly, switching to a biosimilar for medical reasons, like injection site reactions, should be carefully considered and monitored.Lastly, understanding the specific differences between reference biologics and their biosimilars, including excipients, is crucial for personalized treatment decisions.

do you believe more UC patients should consider switching to biosimilars, given the growing evidence of their safety and efficacy?

While biosimilars are a promising option, it’s essential to consider each patient’s unique circumstances. Careful consideration, evaluation, and monitoring are needed before any switch is made. Ultimately, the decision should be made in consultation with a healthcare provider, who can provide personalized guidance based on the patient’s specific needs and medical history.

that’s invaluable insight, Dr. Patel. Thank you for sharing your expertise with our readers at Archyde.

**