Side effects from ravulizumab treatment can be a worry. They are listed in the patient leaflet that comes with every vial of ravulizumab.
Some may have seen in the social media the results of Chinese research which delved into the FDA database (FAERS) to analyse some 9000 plus all time ( seven years) adverse event reports while using ravulizumab. Full research report HERE
All credit to them, analysing a 9000 line excel spreadsheet takes some doing particularly as there is no standard terminology and some reports have multiple events. Other than Global Action no one else has delved into the FAERS database like this.
It would have been harder to do the same for eculizumab because prior to COVID there would have been 6000 reports in a single year. AE reporting during and after COVID dropped of a cliff.
The Zhou et al group concluded that there were four side effects that did not appear in any of the different leaflets for PNH , NOSD, Myasthenia Gravis and aHUS.
These were :
-Anaemia
-Urinary Tract Infection
-Somnolence ( Sleepiness)
-Dysphagia (swallowing difficulty)
Global Action searched the FAERS data to find how many of these new AEs might be reported by aHUS patients in that period . There are a total of around 900 reports ( aHUS AEs tends to be just over 10% of all AEs reported) and the following events were found among them.
- 4 anaemia (2 male, 2 Female )
- 5 Urinary Tract Infection (all female)
- 3 Somnolence (all female)
- 0 Dysphagia
-Anaemia is common in aHUS and it depends how far along the treatment time line it is experienced. If it persistent it may indicate on going hemolysis which may be a drug dosing level issue or a C5 mutation making treatment ineffective. Or left over from the original onset. But this not an unknown issue among aHUS patients.
Complement inhibition does bring with it greater chance of infections , UTI may just be one of several not listed, there were fifteen COVID19 infections for instance. The number of UTIs in the aHUS AEs is less than meningitis and sepsis events (19) and they are rare but they are listed in side effects under meningococcal infections.
Fatigue and tiredness are listed as side effects. Is somnolence like sleepiness or drowsiness just another description of tiredness?
There were no reports of Dysphagia.
So should aHUS be worried. Perhaps not but should Alexion list them on the patients leaflet that is between them and the FDA and needs more analysis than can be found in FAERS.
aHUS patients who visit this site now have the opportunity to know about them thanks to he Chinese research..
Article No 786
