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USA: An international, multisite phase 3 trial published in The Lancet Neurology journal showed the safety and effectiveness of Parkinson’s disease medication delivered through an infusion pump for reducing symptoms for longer periods.

The findings could lead to additional treatment options for patients with this condition. 

Low levels of dopamine in the body can cause Parkinson’s symptoms such as tremors, slowness, and stiffness. For decades, doctors have treated Parkinson’s by giving patients levodopa, the inactive substance in the brain that once converted makes dopamine.

“Levodopa is a replacement strategy. We all make levodopa, but Parkinson’s patients make less of it,” said Espay, co-principal investigator of the trial, James J. and Joan A. Gardner Family Center for Parkinson’s Disease Research Endowed Chair in UC’s Department of Neurology and Rehabilitation Medicine and a physician at the UC Gardner Neuroscience Institute.

Espay said oral levodopa is effective and typically helps people regain normal motor function, but its benefits tend to last less than a few hours after a few years, requiring increases in doses or its frequency.

Levodopa is most commonly administered orally, but this trial tested continuous, 24-hour levodopa delivery through a subcutaneous infusion pump. A total of 381 patients with Parkinson’s disease in 16 countries enrolled in the trial and were randomized to receive levodopa through the infusion pump or through traditional oral medication.

The researchers found levodopa delivered through the infusion pump was safe and led to almost two hours of day (1.72) of additional “on time,” or the time when the medication is working and symptoms are lessened, compared to taking levodopa orally.

Espay said the results of this trial pave the way for this specific infusion pump delivery system to be approved by the Food and Drug Administration and other countries’ respective governing bodies.

“Once approved, this will become an important treatment strategy to consider for patients with Parkinson’s disease experiencing motor fluctuations not adequately controlled with medication,” he said. “Future studies will need to determine the durability of the long-term benefits and whether any safety issues could emerge, as well as how it might compare with deep brain stimulation.”

Two additional subcutaneous delivery systems are also expected to be approved this year, Espay said, and researchers are continuing to study how to improve levodopa formulations and delivery to optimize its effect for patients.

“Levodopa delivery systems are expected to continue to improve over time,” he said. “This is a thriving area of research for the benefits of our patients.”

Reference:

Prof Alberto J Espay, Prof Fabrizio Stocchi, Prof Rajesh Pahwa, Prof Alberto Albanese, Aaron Ellenbogen, Prof Joaquim J Ferreira, Safety and efficacy of continuous subcutaneous levodopa–carbidopa infusion (ND0612) for Parkinson’s disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial, The Lancet Neurology, https://doi.org/10.1016/S1474-4422(24)00052-8.

China: A recent network meta-analysis published in the American Journal of Obstetrics and Gynecology has shed light on the safety and efficacy of treatment modalities for cesarean scar pregnancy (CSP).

A recent real-world study, the APPRAISE study unveiled the effectiveness, tolerability and patient satisfaction with apremilast treatment for individuals with psoriatic arthritis (PsA) which is a chronic autoimmune condition characterized by joint inflammation and skin lesions, affecting millions worldwide.

This research was conducted across multiple Canadian rheumatology clinics and enrolled a total of 102 adults with active PsA. They were prescribed apremilast between July 2018 and March 2020 and were followed for 12 months with visits recommended every four months to monitor the progress. The primary outcome measure focused on achieving remission or low disease activity defined by a Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score of 13 or less. 

The results from this study revealed significant improvements in various markers of disease activity despite 44.1% of the patients discontinuing this study within 12 months. Importantly, 63.7%, 67.2%, and 53.8% of patients achieved cDAPSA remission or low disease activity at 4 months, 8 months, and 12 months, respectively.

The patients who continued the study expressed reduced joint inflammation, pain and psoriasis symptoms. Improvement in treatment satisfaction and patient-reported outcomes, including physical and mental well-being, were obvious over the 12-month period. Safety data indicated that apremilast was well-tolerated, with diarrhea, nausea, and migraine being the most common adverse events leading to discontinuation. 

This study expressed positive outcomes of apremilast in real-world settings, by providing patients with effective relief from PsA symptoms and enhancing their overall quality of life. Overall, these findings contribute to the growing body of evidence that support the clinical effectiveness of apremilast in PsA management.

Reference:

Chandran, V., Bessette, L., Thorne, C., Sheriff, M., Rahman, P., Gladman, D. D., Anwar, S., Jelley, J., Gaudreau, A.-J., Chohan, M., & Sampalis, J. S. (2024). Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study. In Rheumatology and Therapy (Vol. 11, Issue 2, pp. 443–455). Springer Science and Business Media LLC. https://doi.org/10.1007/s40744-024-00641-w