Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
Study Details
Study Description
Brief Summary
Description of the use of fostamatinib in patients with PTI in Andalusia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Fostamatinib is a splenic tyrosine kinase (SYK) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (PTI) refractory to first-line treatments. Data from two phase 3 studies in PTI, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the US and in Europe.
Given the recent commercialization of fostamatinib for PTI, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. These studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy and safety results in real clinical practice in our environment, Andalusia. The pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in Andalusia as of December 31st being greater than 40 cases. For all these reasons, from the Andalusian Group of Congenital Coagulopathies, we propose to collect what the experience has been in our environment. Participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. No clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. This is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PTI patients treated with fosamatinib Patient with criteria of PTI who has been treated with fosamatinib in the time described |
Drug: Fostamatinib
Patitent treated with fostamatinib in the period described
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Description of fostamatinib use [From fostamatinib prescription first date]
Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)
Secondary Outcome Measures
- Response [Whenever it occurs after the start of treatment with fostamatinib]
Platelets count greater than 30x10^9/L and greater than 50X10^9/L at least once during treatment in the absence of combination treatment or rescue therapy.
- Response duration [Whenever it occurs after the start of treatment with fostamatinib]
Duration in weeks of response greater than 30x10^9/L, 50x10^9/L and 100x10^9/L.
- Response failure rate [Whenever it occurs after the start of treatment with fostamatinib]
Platelets count less than 30x10^9/L after four weeks of treatment.
- Efficiency [Whenever it occurs after the start of treatment with fostamatinib]
Identify situations that limits the effectiveness of fostamatinib.
- Rescue treatment [Whenever it occurs after the start of treatment with fostamatinib]
Percentage of patients who required rescue therapy.
- Associated therapies [Whenever it occurs after the start of treatment with fostamatinib]
Percentage of patients who have required therapy for ITP associated with fostamatinib.
- Bleeding [Whenever it occurs after the start of treatment with fostamatinib]
Description of hemorrhagic events.
- Side effects [Whenever it occurs after the start of treatment with fostamatinib]
Description of side effects associated with the use of fostamatinib.
- Security [Whenever it occurs after the start of treatment with fostamatinib]
Number of emergencies, unscheduled visits or hospitalizations for PTI related causes during treatment with fostamatinib.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 18 years or older.
-
Patients with ITP criteria according to clinical practice guidelines.
Exclusion Criteria:
-
Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
-
Subjects with other concomitant hemostatic defects.
-
Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
-
Diagnosis of secondary immune thrombocytopenia.
-
Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Puerta del Mar | Cadiz | Cádiz | Spain | 11009 |
| 2 | Hospital Universitario de Jerez de la Frontera | Jerez De La Frontera | Cádiz | Spain | 11407 |
| 3 | Hospital de Puerto Real | Puerto Real | Cádiz | Spain | 11510 |
| 4 | Hospital de Riotinto | Minas de Riotinto | Huelva | Spain | 21660 |
| 5 | Hospital de la Serranía de Ronda | Ronda | Málaga | Spain | 29400 |
| 6 | Hospital de la Merced de Osuna | Osuna | Sevilla | Spain | 41640 |
| 7 | Hospital Universitario Virgen de las Nieves | Granada | Spain | 18014 | |
| 8 | Hospital Universitario San Cecilio | Granada | Spain | 18016 | |
| 9 | Hospital Universitario Juan Ramón Jiménez | Huelva | Spain | 21005 | |
| 10 | Hospital Universitario de Jaén | Jaén | Spain | 23007 | |
| 11 | Hospital Regional Universitario de Málaga | Málaga | Spain | 29010 | |
| 12 | Hospital Virgen de la Victoria | Málaga | Spain | 29010 | |
| 13 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 14 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
- Principal Investigator: María Eva Mingot Castellano, MD-PhD, Universisty Hospital Virgen del Rocío
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FOSTASUR