There is a limited amount of knowledge known about the pathogenesis of hidradenitis suppurativa (HS). What is known is that patients with HS have an increase in complement C5a, a strong amplifier of inflammation, which is correlated with disease severity. In addition, plasma C5a also primes TNFα production in monocytes. IFX-1 is a human monoclonal antibody that specifically binds to C5a blocking its effect.
AEs were noted in 50% (6) patients with 9 events total (Table).
None were related to IFX-1 and no AEs were fatal.
Secondary endpoints or outcomes
Statistically significant HiSCR was achieved by day 29 compared with day 22 (P<0.05), which was maintained through the open-label treatment period of day 50 in 9 out of 12 patients.
The HiSCR maintained statistical significance through the follow-up period, P=0.09 on day 134 compared to day 50 in 10 out of 12 patients.
Statistical significance was observed for AN count and lesion dimensions both at day 50 during the open-label treatment (P<0.0001 compared to day 22) and again throughout the follow-up period at day 134 (P<0.0001 compared to day 22).
C5a levels were also significantly reduced by day 22 and maintained through day 50 (treatment phase) compared to baseline, P=0.05.
C5a levels began to rise during the follow-up period by day 134 but were still statistically lower than original baseline values, P=0.016.
IFX-1 was well-tolerated in this study and AEs were associated with HS, not to the therapy.
The efficacy of IFX-1 demonstrated promising results with a 75% response in HiSCR at the end of treatment with an 83% HiSCR response at the end of follow-up.
Present disclosure: The presenter has reported honoraria (paid to the University of Athens) from AbbVie, Biotest, Brahms GmbH, and The Medicines Company; has received compensation as a consultant for Astellas Greece, InflaRx GmbH, Germany and for XBiotech (paid to the University of Athens); and has received independent educational grants (paid to the University of Athens) from AbbVie and Sanofi. He is funded by the FrameWork 7 program HemoSpec (granted to the University of Athens) and by the Horizon2020 Marie-Curie Grant European Sepsis Academy (granted to the University of Athens).