Following an initial double-blind phase of the COMET trial, which compared the efficacy and safety of avalglucosidase alfa (Nexviadyme) to alglucosidase alfa (Myozyme), all participants received Nexviadyme in an open-label extension phase. After a further year of treatment, results were published in April 2023:
- Participants who continued their initial treatment with Nexviadyme showed a 2.65% improvement in forced vital capacity (FVC) slightly better than patients who started the trial on Myozyme (0.36%).
- They improved the distance covered in the 6MWT test by 18.6 metres compared with 4.56 m for the group who received Myozyme followed by Nexviadyme.
- Five participants had to stop the trial because of adverse effects linked to enzyme therapy.
- Half the participants experienced moderate side-effects (headache, backache, nausea, etc.), with equal proportions in both groups.
