The retrospective medical chart review study assessed the results of ECP in CTCL-diagnosed patients who initiated ECP treatment between
The study examined patient data from CTCL diagnosis to 18 months post-initiation of ECP. Clinical outcomes collected every three months during treatment for up to 18 months included the BSA affected, appearance of new skin lesions and the physician-rated Clinical Global Impression-Improvement (CGI-I) scores. Patients may have been on concomitant therapies at the time of ECP treatment.
"It is important to continually evaluate real world patterns and outcomes of ECP treatment for CTCL to better understand patients' response to ECP," said
The data analysis found that 19 patients (36.5 percent) had at least a 50 percent reduction in affected BSA with a median time to response of 6.5 months. New skin lesions appeared in 13 patients (25 percent) within a median time of 5.9 months from the initiation of ECP. Among those patients with available data, 27 out of 51 patients (52.9 percent) at three months and 16 out of 20 patients (80 percent) at 18 months, reported as improved (minimally, much or very much) in CGI-I severity scores.1 If exact timepoint was unavailable, physicians were advised to enter the date from closest visit (± four weeks). Per the Prescribing Information, there is no clinical evidence to show that treatment with UVADEX beyond six months provides additional benefit.
The limitations of this retrospective chart review include that the study relied on real world medical charts which could be missing data or may have used site-specific measurement schedules and procedures. Due to the retrospective nature of this analysis, it is hypothesis-generating; no formal conclusions should be drawn. Not all benefit from the analysis may be solely attributable to ECP treatment as patients may have been on multiple therapies at the time of ECP treatment. The study was granted a waiver for ethics review by the WCG [IRB], and when required, by the local IRB at each site.
"As a pioneer in immunomodulation therapy, Mallinckrodt is committed to furthering knowledge and data on the treatment outcomes for CTCL," said
The study was funded by Mallinckrodt.
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is an umbrella term for a group of non-Hodgkin lymphomas involving T lymphocytes that localize in the skin. It is a relatively rare cancer that mostly impacts men between the ages of 40 and 60 and there are about 2,500 to 3,000 new cases of CTCL in the
About Therakos Immunotherapy
IMPORTANT SAFETY INFORMATION
CAUTION: READ THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM'S OPERATOR'S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.
UVADEX is contraindicated in:
WARNINGS AND PRECAUTIONS
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements related to an ongoing, retrospective study in ECP. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: final results of the underlying study; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2100806 12/21
1 Girardi M., Johnson A., Carlson K., et al. Response to Extracorporeal Photopheresis in Patients with Cutaneous T-cell Lymphoma: A Retrospective Medical Chart Review. Poster presented at the:
2 Bradford P, Devesa S, Anderson W, Toro J. Cutaneous lymphoma incidence patterns in
3 Kim YH, Liu HL,
4 Trautinger F, et al. Eur J Cancer. 2006;42(8):1014-1030.
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