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Continued from page 38 but carries fewer restrictions in dosing and monitoring than eltrombopag .
Dr . Tarantino discussed results from two phase II studies and two phase III studies that evaluated avatrombopag in ITP , including a head-to-head comparison trial of avatrombopag and eltrombopag that was discontinued early due to enrollment challenges .
In total , the studies included 128 patients treated with avatrombopag , 11 treated with eltrombopag , and 22 with placebo . Various efficacy analyses from these studies were performed in order to understand the consistency of avatrombopag response across different patient populations in reference to placebo and eltrombopag .
Avatrombopag appeared tolerable , as nearly all patients received the drug for at least seven days and 63.3 % continued treatment for at least 180 days . The average duration of exposure for avatrombopag was 206.4 days , compared with 73.5 days for eltrombopag and 54.9 days for placebo .
In the phase II studies , the median cumulative number of weeks of platelet response ( platelet counts ≥50 × 10 9 / L ) were 11.0 with avatrombopag versus 0 with placebo ( p = 0.0079 ). Results were similar in the placebo-controlled phase III study ( 12.4 weeks with avatrombopag versus 0 weeks with placebo ; p < 0.0001 ), and avatrombopag also appeared to outperform eltrombopag in the headto-head study ( 5.1 weeks with avatrombopag versus 0 weeks with eltrombopag ; p = 0.33 ). Dr . Tarantino added that five eltrombopag-treated patients treated with discontinued study due to an inadequate therapeutic effect , compared with only one avatrombopag-treated patient .
Across the studies , more avatrombopag-treated patients appeared to achieve a platelet count ≥50 × 10 9 / L quickly , within eight days , compared with those who received placebo or eltrombopag . Specifically , in the head-to-head study , mean and median platelet counts and changes in platelet counts from baseline began to favor avatrombopag at two weeks . Bleeding also appeared to be more common among eltrombopag-treated patients , though there were no grade ≥3 bleeds noted in either group and overall rates of AEs were similar .
“ The accumulated efficacy data in the avatrombopag development program demonstrates a consistent effect across different studies conducted in a variety of countries ,” Dr . Tarantino concluded , though he noted several limitations of this analysis , including a small study population and limited head-to-head data .
Study authors in Moulis et al . report relationships with Novartis , the manufacturer of eltrombopag . Study authors in Tarantino et al . report relationships with Dova Pharmaceuticals , the manufacturer of avatrombopag .
References
1 . Moulis G , Rueter M , Lafaurie M , Lapeyre-Mestre M . Eltrombopag for immune thrombocytopenia in adult patients in the real-world in France . Final results of the Elextra study . Abstract # 2662 . Presented at the 2020 American Society of Hematology Annual Meeting , December 7 , 2020 .
2 . Tarantino MD , Vredenburg M , Tian W , et al . Efficacy analyses from the immune thrombocytopenia ( ITP ) clinical development program for avatrombopag : comparisons with placebo and eltrombopag . Abstract # 2677 . Presented at the 2020 American Society of Hematology Annual Meeting , December 7 , 2020 .
e-IRON : Iron-Deficiency Anemia Management at Warp Speed
A telemedicine pilot program to triage and expedite the management of patients with iron-deficiency anemia ( IDA ) who require intravenous ( IV ) iron allowed clinicians to determine appropriate management rapidly , avoiding the traditional time-consuming consultation process . Results of the program were presented by Mark Chaitowitz , MD , from Albert Einstein College of Medicine in New York , at the 2020 ASH Annual Meeting .
IV iron is a rapid , reliable , and safe strategy in addressing IDA , but “ historically , at our institution and at many others , the path to IV iron treatment entails initial referral to hematology , a face-to-face evaluation at a hematology clinic , followed by scheduling for infusion on another visit ,” Dr . Chaitowitz explained .
At Montefiore Medical Center in New York , Dr . Chaitowitz and colleagues developed the e-IRON program to reduce inappropriate delays and decrease the time from referral to infusion . The e-consult platform was made available to referring providers within the institution ’ s electronic medical record system to facilitate an electronic referral to hematology for consideration for IV iron .
The program uses a template-based design to ensure that all information required ( indication , experience with oral iron , current lab work , etc .) is included , Dr . Chaitowitz explained . After being submitted through the platform , e-IRON referrals are reviewed by a specialist hematologist within three business days , and a determination regarding IV iron is made . If deemed appropriate , the patient is scheduled for infusion within 10 business days . The specialist also specifies whether a face-to-face hematology appointment is required . In cases where IV iron is not deemed appropriate , the hematologist will provide guidance as to alternate management .
The e-IRON program was evaluated in an initial 75-day evaluation period , during which 81 referrals were received . The most common referrals were for anemia in pregnancy and IDA that is not responsive or intolerant to oral iron . Results of the hematologist review of the cases were as follows :
• IV iron is indicated : 58 instances
• IV iron is indicated , along with a face-to-face appointment : 2 instances
• Lab work not current ( complete blood count / iron studies older than 30 days ): 7 instances
• More information needed : 3 instances
• Treatment other than IV iron recommended : 11 instances
Nearly all the recommendations ( n = 77 ; 95 %) were generated within three business days , and within one day for more than half of patients ( n = 47 ; 58 %). Recommended IV iron regimens all entailed one or two infusion days , depending on the estimated iron deficit , and all first infusions were scheduled within two weeks of the request .
“ The value of this paradigm shift in patient care [ to telemedicine ] is underscored by lessons learned during the ongoing COVID-19 pandemic .”
“ Reasons for non-approval of IV iron varied , but the most common reason cited was an inadequate trial of oral iron , in which case specific instructions were provided for oral iron supplementation ,” Dr . Chaitowitz noted .
Based on this experience , Dr . Chaitowitz concluded that the e-IRON pilot project demonstrates the feasibility and efficacy of a telemedicine approach in triaging and expediting the management of patients requiring IV infusion . “ The platform ensures effective supervision by specialist hematologists , but dispenses with the laborious , costly , and time-consuming traditional requirement of a face-to-face visit to the hematology clinic ,” he concluded . “ The value of this paradigm shift in patient care is underscored by lessons learned during the ongoing COVID-19 pandemic .” ●
Study authors report no relevant conflicts of interest .
Reference
— Mark Chaitowitz , MD
Wilson C , Lee W , Cook M , et al . E-Iron : rethinking the way we deliver intravenous iron . Report of a pilot telemedicine initiative . Abstract # 425 . Presented at the 2020 American Society of Hematology Annual Meeting , December 6 , 2020 .
40 ASH Clinical News March 2021