Janssen Pharmaceuticals Inc., of Titusville, N.J., part of Johnson & Johnson, released the results of its landmark PRIDE (Paliperidone Palmitate Research In Demonstrating Effectiveness) trial to compare medications within the context of many "real world" issues in the treatment of schizophrenia. Invega Sustenna showed statistical superiority against the primary endpoint, delaying relapse in patients with schizophrenia, as well as in reducing overall relapse, compared to the most commonly used treatments, daily oral antipsychotics (median 416 days vs. median 226 days; p = 0.011). The risk of relapse was 1.4 times higher (95 percent CI: 1.09, 1.88, p = 0.011) in the oral group vs. the Invega Sustenna group. The study evaluated 444 adults who had been diagnosed with schizophrenia and were taken into custody by the criminal justice system at least twice in the previous two years with at least one custody resulting in incarceration. In addition, participants must have been released from their most recent custody within 90 days of screening for the trial. The 15-month U.S. study assessed as its primary endpoint the time to treatment failure, which is a subset of relapse. The endpoint was defined as any one of the following: psychiatric hospitalization; arrest/incarceration; suicide; treatment supplementation or discontinuation of antipsychotic medication because of inadequate efficacy, safety concerns or tolerability issues; or increased level of psychiatric services in order to prevent psychiatric hospitalization.

Novartis AG, of Basel, Switzerland, presented results from a pivotal phase III trial of investigational therapy Signifor LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control. The findings showed that patients taking pasireotide long-acting release (LAR) achieved greater disease control when compared to continued treatment with the standard somatostatin analogue therapies, octreotide LAR or lanreotide Autogel. The multicenter phase III study was a randomized, double-blind trial examining pasireotide LAR 40 mg or pasireotide LAR 60 mg vs. continued open-label treatment with octreotide LAR 30 mg or lanreotide Autogel 120 mg (the control group) for 24 weeks. The trial included 198 patients with inadequately controlled acromegaly on maximum approved doses of octreotide LAR or lanreotide Autogel for at least six months, regardless of prior surgical status. The primary endpoint was the proportion of patients achieving biochemical control as measured by mean GH levels of less than 2.5 μg/L and normalized IGF-1 at 24 weeks. The data were presented at the 16th European Congress of Endocrinology in Wroclaw, Poland.

UCB SA, of Brussels, Belgium, reported results from the PRECiSE 3 seven-year open-label extension trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease. Remission was also assessed over the trial period. In total, 595 patients enrolled following the completion of the PRECiSE 1 and 2 pivotal studies (354 enrolled from PRECiSE 1 and 241 enrolled from PRECiSE 2) and received certolizumab pegol (CZP) 400 mg every four weeks for up to seven years. No new safety signals were identified during the study. However, patients treated with Cimzia are at an increased risk for developing serious infections that may lead to hospitalization or death. In the observed case analysis of the study, annual remission rates ranged from 68 percent (269 out of 394 patients still in the study) to 76 percent (78 out of 103 patients still in the study) from year one to year seven, as defined by a Harvey Bradshaw Index score of less than four. The remission rates analyzed by last observation carried forward and nonresponder imputation methods were 58 percent (347 out of 594 patients) and 45 percent (266 out of 594) at year one, 56 percent (331 out of 594) and 26 percent (152 out of 594) at year three, and 55 percent (325 out of 594) and 13 percent (78 out of 594) at year seven, respectively. Results were presented at Digestive Disease Week in Chicago.