Saint-Prex, Switzerland:
- New study demonstrates that individualised dosing with Rekovelle® (follitropin delta) was comparable to conventional dosing with follitropin alfa in terms of ongoing pregnancy rate in a broad Asian population.1
- Additional data relating to pre-defined secondary endpoints showed that individualised dosing with Rekovelle significantly increased live birth rates in normal and high responders.2 Moreover, a post hoc analysis of a randomised clinical trial found that Rekovelle and follitropin alfa dosing regimens were similar in terms of live birth rate in frozen replacement cycles.3
- All data support previous findings showing that ovarian stimulation with the individualised Rekovelle dosing regimen reduced the risk of ovarian hyperstimulation syndrome (OHSS) without compromising efficacy.1,2,4,5
New data, presented today at the 37th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), show a comparable ongoing pregnancy rate of 31.3% with the individualised dosing regimen of Rekovelle, compared to 25.7% with follitropin alfa (adjusted difference 5.4% [95% CI:-0.2%; 11.0%]) amongst all ages in an Asian study population (mainland China, South Korea, Vietnam and Taiwan). 1 The live birth rate was significantly higher at 31.3% with Rekovelle compared to 24.7% with follitropin alfa (adjusted difference 6.4% [95% CI: 0.9%; 11.9%]; p<0.05). This was a pre-defined secondary endpoint so no confirmatory conclusions can be drawn.1
In the GRAPE study (a randomised, controlled, assessor-blind pan-Asian trial comparing individualised Rekovelle (follitropin delta) with conventional follitropin alfa), comparable pregnancy rates were achieved alongside a significant reduction in early OHSS incidence (5.0% with Rekovelle versus 9.6% with follitropin alfa). Among patients with AMH ≥15 pmol/L, excessive response occurred less frequently with individualised than conventional dosing (≥15 oocytes: 20.2% versus 39.1%; ≥20 oocytes: 6.7% versus 18.5%).1 These secondary data endpoints support previous studies which have found that individualised Rekovelle dosing reduces the risk of ovarian hyperstimulation syndrome (OHSS) and interventions to prevent it versus the conventional approach.4,5
“These data imply that, in addition to reducing the early OHSS risk, individualised dosing with follitropin delta has the potential to increase the live birth rate in fresh cycle across all ages,” said Professor Jie Qiao, Academician of Chinese academy of engineering, Vice President of China Association for science and technology, Executive Vice President of Peking University, Director of Peking University Health Science Center, President of Peking University Third Hospital, Academician of American Academy of Arts and Sciences (IHM). “The data offer – for the first time – important support for the use of this treatment in the Asian population.”
A new, independent individual patient data – meta-analysis (IPD-MA) of nearly 2,700 women randomised to a conventional dosing regimen with follitropin alfa or beta, or individualised dosing with Rekovelle, supports the above findings.2 The occurrence of early OHSS was significantly reduced in the individualised Rekovelle group (4% vs. 6.4%). The study found that live birth rates were comparable in individuals who received individualised Rekovelle treatment compared to those who received follitropin alfa or beta. Moreover, the live birth rate in normal to high responders was significantly increased in those receiving individualised Rekovelle (31.4% vs. 25.9%).2 “The results of the IPD-MA support previous data which has shown that an individualised follitropin delta dosing regimen reduces the risk of OHSS without compromising efficacy,” said Dr Femi Janse of the Nij Barrahus Fertility Clinic. “They also offer insights for clinicians seeking to tailor their treatment approach for normal and high responder patients.”
Additional analysis from the ESTHER-1 and 2 clinical trials – also announced at this year’s ESHRE – show that Rekovelle and follitropin alfa dosing regimens were non-inferior in terms of live birth rate in frozen replacement cycles.3 The analysis of 917 women who participated in the ESTHER-1 and 2 trials found that the live birth rate per started frozen cycle was 32.0% in the Rekovelle group and 31.3% in the follitropin alfa group (adjusted difference 1.2% [95% CI: -6.8%; 9.3%]).3
“At Ferring we believe in everyone’s right to a family, so are pleased to announce emerging data showing the benefits of the individualised Rekovelle dosing regimen in new populations and patient groups,” saidMirjam Mol-Arts, Chief Medical and Science Officer at Ferring. “In addition,the expanded AMH assay options now included in the EU label are additional features allowing expansion of current treatment boundaries.”
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