Secondary endpoints were complete remission, minimization of prednisone, quality of life, antibody levels, and clinician measures including the PDAI and the Autoimmune Bullous Skin Disorder Intensity Score.
The PDAI fell by a median of 70% by week 12 and was maintained at that level by the end of week 24.
The good results obtained were confirmed by others [54, 55], showing higher rate of response and lower recurrences with EUA plus IFX than with IFX alone , and a decrease of PDAI after EUA plus IFX .
Abbreviations ADA: Adalimumab AGA: American Gastroenterological Association ASCs: Adipose derived stem cells CD: Crohn's disease EUA: Examination under anesthesia EUS: Endoanal ultrasonography GETAID: Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif IFX: Infliximab LIFT: Ligation of the intersphincteric fistula track MRI: Magnetic resonance imaging PDAI: Perianal disease activity index RVF: Rectovaginal fistula VAAFT: Video-assisted anal fistula treatment.
During the second 12-week phase of the trial, after discontinuation of PRN1008, most patients retained their on-treatment reduction in total PDAI scores.
Murrell noted that the gradient of improvement in PDAI scores seen with PRN1008 in the Believe-PV study was quite similar to that seen in a recent 90-patient French randomized trial of rituximab (Rituxan) for the treatment of pemphigus.