title: Physician and patient benefit-risk preferences from two randomized long-acting injectable antipsychotic trials.
abstract: OBJECTIVE
  To quantify clinical trial participants' and investigators' judgments with respect to the relative importance of efficacy and safety attributes of antipsychotic treatments for schizophrenia, and to assess the impact of formulation and adherence.
  
  
  METHODS
  Discrete-choice experiment surveys were completed by patients with schizophrenia and physician investigators participating in two phase-3 clinical trials of paliperidone palmitate 3-month long-acting injectable (LAI) antipsychotic. Respondents were asked to choose between hypothetical antipsychotic profiles defined by efficacy, safety, and mode of administration. Data were analyzed using random-parameters logit and probit models.
  
  
  RESULTS
  Patients (N=214) and physicians (N=438) preferred complete improvement in positive symptoms (severe to none) as the most important attribute, compared with improvement in any other attribute studied. Both respondents preferred 3-month and 1-month injectables to oral formulation (P<0.05), irrespective of prior adherence to oral antipsychotic treatment, with physicians showing greater preference for a 3-month over a 1-month LAI for nonadherent patients. Physicians were willing to accept treatments with reduced efficacy for patients with prior poor adherence. The maximum decrease in efficacy (95% confidence interval [CI]) that physicians would accept for switching a patient from daily oral to 3-month injectable was as follows: adherent: 9.8% (95% CI: 7.2-12.4), 20% nonadherent: 25.4% (95% CI: 21.0-29.9), and 50% nonadherent: >30%. For patients, adherent: 10.1% (95% CI: 6.1-14.1), nonadherent: the change in efficacy studied was regarded as unimportant.
  
  
  CONCLUSIONS
  Improvement in positive symptoms was the most important attribute. Patients and physicians preferred LAIs over oral antipsychotics, with physicians showing a greater preference for 3-month over 1-month LAI. Physicians and patients were willing to accept reduced efficacy in exchange for switching a patient from an oral formulation to a LAI.
authors: Janssen Research & Development, LLC, Raritan, NJ.
authors: Eva G
authors: EG
authors: Katz
authors: RTI Health Solutions, Research Triangle Park, NC.
authors: Brett
authors: B
authors: Hauber
authors: Janssen Research & Development, LLC, Titusville, NJ.
authors: Srihari
authors: S
authors: Gopal
authors: RTI Health Solutions, Research Triangle Park, NC.
authors: Angie
authors: A
authors: Fairchild
authors: The University of California, San Francisco (UCSF), CA, USA.
authors: Amy
authors: A
authors: Pugh
authors: Janssen Research & Development, LLC, Titusville, NJ.
authors: Rachel B
authors: RB
authors: Weinstein
authors: Janssen Research & Development, LLC, Titusville, NJ.
authors: Bennett S
authors: BS
authors: Levitan
keywords: benefit–risk assessment; long-acting injectable; patient preference; physician preference; schizophrenia; survey