Evaluating the relationship between antidrug antibodies and efficacy and safety outcomes in patients with Fabry disease receiving enzyme replacement therapy: a systematic literature review.

What was studied

This review asked if antibodies to enzyme therapy change outcomes in Fabry disease. The therapy can slow the disease. But it may cause antidrug antibodies. The team searched MEDLINE, Embase, the Cochrane Library and trial registries. They screened 1763 articles and included 24. They looked at disease markers, kidney outcomes, heart outcomes and side events.

What they found

In 17 of 18 marker analyses, antibody-positive patients had higher marker levels. The links were statistically significant. The markers were lyso-Gb3, plasma Gb3 and urine Gb3. In 2 of 9 kidney data sets, kidney function may have fallen faster. These were antibody-positive patients. 4 of 9 studies linked antibodies to infusion reactions. In 5 of 7 studies, these reactions were more common in antibody-positive groups.

What it means for patients

The authors say antibodies may go with more infusion reactions. They say antibodies may harm some measures of how well the therapy works.

Why it is not certain yet

The authors say the data were inconsistent. They tie this to study design. Examples are prior therapy, follow-up time and antibody testing methods. They call for more prospective studies using standard antibody tests. They say cause and effect still needs study.

Source

Evaluating the relationship between antidrug antibodies and efficacy and safety outcomes in patients with Fabry disease receiving enzyme replacement therapy: a systematic literature review.

We restate facts from the source record in our own words. The original wording belongs to its publisher.