But he also said the drug's safety profile needs close examination in future trials, as this phase II study was not powered for any but the most common side effects.Overall, said Wray, "for the most part it appeared to be a well-tolerated drug." Sandborn had noted one case of perforation in one of the dosing groups, but "it's really hard to say if that was related to the drug or just the severe Crohn's disease," said Wray.Marque d'envergure mondiale largement reconnue, Verbatim vend ses produits dans plus de 120 pays.Au cours des cinq dernières années, elle a connu la plus grande part de marché au niveau mondial pour les disques optiques enregistrables vendus, toutes marques confondues*.ABT-494 is also now in a phase III trial for rheumatoid arthritis, and studies are underway in a variety of other autoimmune conditions, including ulcerative colitis, psoriatic arthritis, and psoriasis. Wray reported no financial relationships with industry.
But adverse events leading to discontinuation were more even, occurring in 14% of the placebo group compared with 3%-25% of the active drug groups.About two-thirds of the sample had failed at least two TNF inhibitors.Sandborn said this was "the most refractory group ever recruited" for a Crohn's disease trial.In consequence -- and because the FDA has recognized the problem and asked for it -- the trial defined clinical remission on the basis of pain scores and liquid/soft stool frequency.
In particular, to be considered in remission, patients had to have a stool frequency of no more than 1.5 per day and abdominal pain score of no more than 1.0 at week 16, with no worsening from baseline in either measure. Session moderator Curtis Wray, MD, of UT Health in Houston, who was not involved with the trial, agreed that it would be important to continue to evaluate exactly how the endpoints are defined.Additionally, patients had Simplified Endoscopic Scores for Crohn's disease of at least 6 (or at least 4 for those with isolated ileal disease).