Providing specific definitions for compliance and persistence is important for sound quantitative expressions of patients' drug dosing histories and their explanatory power for clinical and economic events. Adoption of these definitions by health outcomes researchers will provide a consistent framework and lexicon for research.
Patients with persistent/chronic immune thrombocytopenia (cITP) have low platelet counts, increased risk of bleeding and bruising, and often suffer from reduced health‐related quality of life (HRQoL). cITP treatments may either improve HRQoL by increasing platelet counts or decrease it because of side effects. The open‐label EXTEND study (June 2006 to July 2015) evaluated long‐term safety, tolerability, and efficacy of eltrombopag (an oral thrombopoietin‐receptor‐agonist) in adults with cITP who completed a previous eltrombopag ITP trial. The final results of EXTEND were published and used to assess changes in patient‐reported HRQoL over time and association between HRQoL and platelet response. Four validated HRQoL instruments were administered: SF‐36v2 including physical component summary (PCS) and Mental Component Summary; Motivation and Energy Inventory Short Form (MEI‐SF); Fatigue Subscale of FACIT (FACIT‐Fatigue); and FACT‐Thrombocytopenia Subscale Six‐Item Extract (FACT‐Th6). For the 302 patients enrolled, median duration of eltrombopag treatment was 2.37 years. All 4 HRQoL instruments demonstrated positive mean changes from baseline over time adjusted for patient baseline characteristics and rescue therapy use, and had positive association with platelet response (platelet count ≥30 × 109/L; ≥50 × 109/L; and ≥50 × 109/L and >2 times baseline). Improvements from baseline started within 3 months and persisted through 5 years of treatment for FACIT‐Fatigue and FACT‐Th6 (P <.05 for nearly all time points); through 2.5 years for SF‐36v2 PCS and less consistently for the MEI‐SF. In conclusion, in addition to eltrombopag increasing platelet counts and reducing bleeding/bruising, it also alleviated fatigue, concerns about bleeding and bruising, and improved physical function in many patients, especially responders.
Re-treatment with bortezomib was common; novel agents were reserved for later therapy lines. Overall, the observed PFS associated with real-world treatment sequences were shorter than those reported in clinical trials.
<b><i>Background:</i></b> Recent evidence suggests that in patients with immune thrombocytopenia (ITP) with a stable response on thrombopoietin receptor agonists, treatment may be tapered and/or discontinued. <b><i>Objectives:</i></b> The objective of this study was to provide a guide for tapering and discontinuation of TPO-RA therapy in patients with ITP, based on hematologist survey results, existing evidence, and expert consensus. <b><i>Patients/Methods:</i></b> UK hematologists completed a survey to characterize self-reported practice patterns related to TPO-RA tapering and discontinuation in patients with ITP. Using a modified Delphi panel approach, ITP experts developed consensus statements regarding the use of TPO-RA tapering and discontinuation. <b><i>Results:</i></b> Survey respondents estimated that 30–34% of their patients were suitable for tapering or discontinuation and that 29–35% of these patients required treatment re-initiation after an average treatment-free interval of 86–106 days. No clear predictors of patient suitability or response to tapering or discontinuation were identified. The ITP expert consensus was that approximately 30% of patients are eligible for tapering and discontinuation, which may be considered after 6–12 months for patients demonstrating an adequate treatment response (platelet count >50,000/µL at ≥75% of assessments in the preceding 6 months). Treatment re-initiation may be considered if the platelet count decreases or if the patient becomes symptomatic. Individual differences need to be taken into account when considering TPO-RA tapering or discontinuation. <b><i>Conclusions:</i></b> Tapering and discontinuation of TPO-RA therapy may be considered for certain patients with ITP. Further study is needed to better predict patients likely to achieve sustained off-treatment responses after tapering and discontinuation.
In currently employed individuals, self-perceived cognitive dysfunction worsened with increasing severity of depressive symptoms. This association was independent of antidepressant use. The greatest impairment in self-perceived cognition was observed in the planning/organization and attention/concentration subscales.
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