What Have We Learned from Meta-analyses of Clinical Trials
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1 Prevention in Schizophrenia: The Earlier Use of Long Acting Injectable Medications What Have We Learned from Meta-analyses of Clinical Trials 2016 IPS: The Mental Health Services Conference in Washington DC Taishiro Kishimoto, M.D., Ph.D. Assistant Professor, Keio University School of Medicine, Tokyo, Japan Assistant Professor, Hofstra Northwell School of Medicine, NY, USA
2 Disclosure Consultant Fee Dainippon-Sumitomo, Meiji, Novartis, Prophase, Taisho Speaker s Honoraria Abbvie, Banyu, Dainippon-Sumitomo, Eli Lilly, Janssen, Mochida, Novartis, Otsuka, Pfizer, Shionogi Scholarship The Byoutaitaisyakenkyukai Fellowship (Fellowship of Astellas Foundation of Research on Metabolic Disorders), The Japanese society of Neuropsychopharmacology (Eli Lilly Fellowship for Clinical Psychopharmacology) Research Grant Danippon-Sumitomo, Otsuka, Mochida, Shionogi Provision of Research Equipment Cisco, IIJ, V-cube, Omron, PST No stocks or other income from any entity
3 Natural History of Schizophrenia Good Function Premorbid Prodromal Progression Psychopathology Stable relapsing Poor Age (years old) Lieberman, J.A. : Journal of Clinical Psychiatry, 57 (S.11), 68-71, 1996
![Stopping medication is the most powerful predictor of relapse Year from the Previous Episode Relapse Rate [95%CI] 1 st Relapse 104 Pts at](/docs-images/73/69197096/images/4-0.jpg "Risk Patients Remaining at Risk at End of Year, No. Risk of relapse when NOT taking medication 1 16.2 [8.9-23.4] 80 2 53.7 [43.4-64.")
![0] 36 3 63.1 [52.7-73.4] 22 4 74.7 [64.2-85.2] 9 5 81.9 [70.6-93.2] 4 6 2 nd Relapse 63 Pts at Risk 5 4.57 1 19.1 [8.4-29.9] 4 36 2 48.7 [33.](/docs-images/73/69197096/images/4-3.jpg "6-63.9] 3 17 2 3 56.0 [43.2-80.2] 10 1 4 56.0 [43.2-80.2] 0 3 5 78.0 [46.5-100.0] Second 1 relapse Robinson D, et al.")
4 Stopping medication is the most powerful predictor of relapse Year from the Previous Episode Relapse Rate [95%CI] 1 st Relapse 104 Pts at Risk Patients Remaining at Risk at End of Year, No. Risk of relapse when NOT taking medication [ ] [ ] [ ] [ ] [ ] nd Relapse 63 Pts at Risk [ ] [ ] [ ] [ ] [ ] Second 1 relapse Robinson D, et al. Arch Gen Psychiatry 1999;56:241 7
5 Leucht et al. Lancet 2012
6 AP continuation vs PBO for Relapse Prevention Leucht et al. Lancet 2012
7 AP continuation vs PBO for Relapse Prevention: Sensitivity analyses Leucht et al. Lancet 2012
8 Adherence in Various Diseases Disease # studies Mean Adherence (%) 95%CI HIV Disease Arthritis Cancer Cardio Vascular Diseases Infectious Disease Diabetes DiMatteo. Mecial Care 2004
9 Non-/Poor Adherence Rate in Schizophrenia Based on Real World Clinical Data Country, Population Schizophrenia, Norway (Jónsdóttir H et al. 2010) Schizophrenia, USA (Dibonaventura M et al. 2012) Schizophrenia, Nigeria (Adelufosi AO 2012) Schizophrenia, USA Medicaid beneficiaries (Gilmer TP et al. 2004) Schizophrenia, USA VA (Valenstein M et al. 2004) Schizophrenia, first episode (Perkins DO et al. 2008) Schizophrenia, USA VA (Valenstein M 2006) Schizophrenia, France (Dassa D et al. 2010) Number of Patients 280 Measurement Method Serum concentration Non-/poor Adherence 58.4% 876 Self-report 48.4% 313 Self-report 40.3% 2,801 Pharmacy Records 40% 63,214 Pharmacy Records 40% 400 Discontinuation against medical advice 37.1% (K-M curve) 28.8% (raw) 34,128 Pharmacy Records % 291 Self-report 30.0% Kane, Kishimoto and Correll. World psychiatry 2013
10 Long Acting Injections Minimise Therapy Disruptions Assure medication delivery Immediate awareness of non-adherence No abrupt loss of efficacy if dose missed Freedom from daily medication etc. Needle pain Possible emergence of injection site side effects Impossible to discontinue/reduce dosage immediately etc.
11 RIS LAI vs Oral AP -Unstable Schizophrenia Time to Hospitalization after Randomization n=187 n=182 Rosenheck et al. N Engl J Med 2011
12 RIS LAI vs Oral Antipsychotics: PROACTIVE Study Buckley et al. Scz Bull 2014
13
14 Methods -Inclusion Criteria RCTs comparing LAIs vs. OAPs Long-term studies ( 6 months) Providing relapse-related information (e.g. study-defined relapse, rehospitalization) Both in- and out-patient studies Kishimoto T et al. Schizophrenia Bulletin 2013
15 Methods -Outcomes Primary outcome: Relapse as defined in the original studies (estimated rate derived from survival curve, raw rate if not available) Secondary outcome: Relapse at 3, 6, 12, 18, 24 months All-cause discontinuation Discontinuation due to adverse events Drug inefficacy (relapse + discontinuation due to inefficacy) Hospitalization Non-adherence Kishimoto T et al. Schizophrenia Bulletin 2013
16 Methods Data Analysis LAIs were compared to OAPs both individually and pooled Risk Ratio together with 95% CI Random effect model Number Needed to Treat Kishimoto T et al. Schizophrenia Bulletin 2013
17 Results: Study Characteristics # Studies 21 studies Publication Year (There was 14 years gap between 1991 and 2005) # Patients 5130 ( per study (median 105)) Duration Blinding Status LAI Medication Oral Medication 66.4 ± 32.2 weeks (< 1 year: N=4, > 1 year: N=17) Double blind, double dummy: 9 Rater-masked: 5 Open label: 7 Fluphenazine 8, HAL1, Trifluperazine 1, Zuclopenthixol 1, RIS 9, OLA 2 Fluphenazine 4, Pimozide 2, HAL 1, Trifluperazine 1, Zuclopenthixol 1, OLA 4, QUE 2, RIS 2, ARI 1, previous/physician s choice 3 LAI drug was different from oral drug: 11/21 Kishimoto T et al. Schizophrenia Bulletin 2013
18 LAI vs Oral AP Relapse (Individual LAI) Kishimoto T et al. Schizophrenia Bulletin 2013
19 Kishimoto T et al. Schizophrenia Bulletin 2013
20 LAI vs Oral AP: Relapse (Pooled) Kishimoto T et al. Schizophrenia Bulletin 2013
21 LAIs vs OAPs: Relapse Specific Time Points N n Relative Risk [95%CI] P Relapse at 3 month [0.70, 1.17] 0.21 Relapse at 6 month [0.76, 1.14] 0.48 Relapse at 12 month [0.75, 1.08] 0.27 Relapse at 18 month [0.67, 1.13] 0.29 Relapse at 24 month [0.70, 1.19] 0.51 Kishimoto T et al. Schizophrenia Bulletin 2013
22 LAIs vs OAPs: Other Outcomes N n Relative Risk [95%CI] P All cause discontinuation [0.89, 1.12] 0.40 Hospitalization [0.76, 1.03] 0.11 Drug inefficacy (relapse + dropout due to inefficacy) Dropout due to adverse events [0.82, 1.15] [0.73, 1.64] 0.66 Non-adherence [0.50, 1.20] 0.46 Kishimoto T et al. Schizophrenia Bulletin 2013
23 LAIs vs OAPs: Relapse Sensitivity Analyses Subgroup N n RR 95%CI P Double blind double dummy [0.68, 1.09] 0.21 Outpatient status [0.76, 1.05] 0.17 >1 year [0.77, 1.07] 0.25 Same AP in LAI and OAP arm [0.78, 1.09] 0.35 Outpatient status + 1 year [0.74, 1.04] 0.12 Kishimoto T et al. Schizophrenia Bulletin 2013
24
25 Mirror-Image Study Oral Antipsychotics Long Acting Injection Pt 2 Pt 6 Pt 1 Pt 4 Pt 5 Pt 3 Admission Mirror-image study compares what happens before and after the introduction of a new treatment, using equal intervals. Each patient serve as his/her own control.
26 Inclusion Criteria: Mirror-image study comparing the period before and after the initiation of LAI 12 months ( 6moths each on OAP and LAI) Studies providing hospitalization or relapse-related information. Co-Primary outcomes: Hospitalization risk (proportion of pts who had 1 hospitalization), # of hospitalization Secondary outcomes: hospitalization days, length of 1 hospitalization. Kishimoto T et al. J Clin Psych 2013
27 Result: Mirror Image Study Characteristics Number of Studies 25 Number of Countries 28 Publication Year Number of Patients Mean study duration Prospective Studies (in the post- LAI phase) LAI Medication Total 5825 ( per study) 20.9±15.9 months ( months) 3/25 RIS 11, first generation antipsychotics (FGA) 11, RIS or FGA1, not reported 2 Oral Medication Any 3, SGA 1, OLA1, not reported 20 Kishimoto T et al. J Clin Psych 2013
28 LAI vs. Oral Antipsychotics Mirror-Image Studies [Hospitalization Risk] Study name Outcome Statistics for each study Risk ratio and 95% CI Risk Lower Upper ratio limit limit Z-Value p-value Girardi et al Hospitalization Risk Beauclair et al Hospitalization Risk Arato & Erdos 1979 Hospitalization Risk Devito et al Hospitalization Risk Denham & Adamson 1971 Hospitalization Risk Morritt 1974 Hospitalization Risk Lam et al Hospitalization Risk Lindholm 1975 Hospitalization Risk Peng et al Hospitalization Risk Gottfries & Green 1974 Hospitalization Risk Rosa et al Hospitalization Risk Chang et al Hospitalization Risk Johnson & Freeman 1972 Hospitalization Risk Crivera et al Hospitalization Risk Ren et al Hospitalization Risk Svestka et al Hospitalization Risk studies, 4066 patients Risk Ratio=0.43, 95%CI: , p< NNT= Favours LAI Favours OAP Kishimoto T et al. J Clin Psych 2013
29 LAI vs. Oral Antipsychotics Mirror-Image Studies [# of Hospitalization] Study name Outcome Statistics for each study Rate ratio and 95% CI Rate Lower Upper ratio limit limit Z-Value p-value Beauclair et al # Hospitalization Arato & Erdos 1979 # Hospitalization Waldman & Neuman 1984 # Hospitalization Denham & Adamson 1971 # Hospitalization Morritt 1974 # Hospitalization Malm 1971 # Hospitalization Devito et al # Hospitalization Polonowita & James 1976 # Hospitalization Chang et al # Hospitalization Carswell et al # Hospitalization Lindholm 1975 # Hospitalization Peng et al # Hospitalization Ren et al # Hospitalization Tan et al # Hospitalization Bourin et al # Hospitalization studies, 6396 person years Rate Ratio=0.38, 95%CI: , p< Favours LAI Favours OAP NNT=2 Kishimoto T et al. J Clin Psych 2013
30 Outcomes Study N Effect Size [95%CI] P-value Secondary Outcomes Days Hospitalized 7 Hedge s g <0.01 Length of 1 Hospitalization 2 Hedge s g <0.001 Sensitivity Analysis Hospitalization Risk FGA-LAI=Old studies (-1999) 8 Risk ratio <0.001 SGA-LAI 7 Risk ratio <0.001 New studies (2000-) 8 Risk ratio <0.001 ITT analysis 6 Risk ratio <0.001 # of Hospitalization FGA-LAI=Old studies (-1999) 10 Risk ratio <0.001 SGA-LAI 4 Risk ratio <0.001 New studies (2000-) 5 Risk ratio <0.001 ITT analysis 5 Risk ratio <0.001 Kishimoto T et al. J Clin Psych 2013
31 Mirror Image Studies: Major Limitations Expectation Bias Regression to the Mean Switch from OAPs to LAIs Time Effect The clinician and family know that the patient is still on medication Patients are likely to return to their usual status after a while even if the medication remains unchanged All studies included in the analysis was from OAPs to LAIs Health policy change and reduction in bed numbers or insurance coverage
32
33 What is the most informative design to examine LAI efficacy? Study Design Result Limitation RCT Mirror-Image Study Cohort Study LAI Oral LAI» Oral Heterogeneous Selection bias (pts in RCT are more adherent) Alterations to the ecology of treatment delivery and experience (reminder, assessment, compensation etc.) Expectation bias, influence of independent factors (bed reduction etc.) Selection bias (pts on LAI are more severe) Kishimoto T et al. SIRS 2012
34 Long Acting Injectable Risperidone vs Oral Risperidone in First Episode Subotnik et al JAMA Psych 2015
35 Paliperidone Palmitate vs Oral APs (PROSIPAL) in recently diagnosed schizophrenia Schreiner et al. Schizophrenia Res 2015
36 J Clin Psychi 2015
37 Safety and tolerability of LAI vs oral antipsychotics: RCT comparing the same antipsychotics Discontinuation due to adverse events 16 RCTs (n=4902, mean age=36.4 years, males=65.8%, schizophrenia=99.1%) Misawa, Kishimoto et al. Schizphr Res 2016
38 All Cause Death LAIs and OAPs did not differ significantly regarding 115/119 adverse events including discontinuation due to AE, death, serious adverse events. Death Excluding Accident and Suicide Compared to OAPs, LAIs were associated with significantly more akinesia, low-density lipoprotein cholesterol change and anxiety. LAIs were associated with significantly lower prolactin change. Misawa, Kishimoto et al. Schizphr Res 2016
39 Summary 1 In RCTs, LAIs are not superior to OAPs in preventing relapse as well as other relapserelated outcomes. Patients in RCTs might enroll a disproportionate number of patients with better adherence and lower illness severity. Some newer evidences show LAIs superiority over OAPs in recent onset and/or specific patient populations.
40 Summary 2 LAIs are more effective than OAPs in real world evidence Mirror image studies Cohort studies Safety: There is no convincing evidence that LAIs are more dangerous than OAPs.
41 Thank you very much for your attention. Taishiro Kishimoto, M.D., Ph.D. Assistant Professor, Keio University School of Medicine, Tokyo, Japan Assistant Professor, Hofstra Northwell School of Medicine, NY, USA
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