#scelta Biosimilari | Giampiero Girolomoni

Transcript

1. UNIVERSITÁ  DEGLI  STUDI  DI  VERONA   FACOLTÁ  DI  MEDICINA  E  CHIRURGIA   Dipar8mento  di  Medicina   Sezione  di  Dermatologia  e  Venereologia     REGIONE  DEL  VENETO   AZIENDA  OSPEDALIERA  UNIVERSITARIA   INTEGRATA  DI  VERONA   U.O.    dU  Clinica  Dermatologica   Giampiero  Girolomoni   BIOSIMILARI   COSA  NE  PENSA  IL  MEDICO    
2. 1.  E’  clinicamente  acce>abile  uAlizzare  indifferentemente  il  farmaco  biosimilare  al   posto  del  suo  originatore?   2.  Poiché  l’originator  e  il  biosimilare  hanno  la  stessa  indicazione  terapeuAca,  è   corre>o  parlare  di  “equivalenza  terapeuAca”?  In  quali  casi?   3.  La  conAnuità  terapeuAca  è  importante  per  la  tutela  della  qualità  e  dell’   efficacia  della  cura  per  il  paziente?   4.  Paziente  naive.  E’  acce>abile  l’impiego  preferenziale  dei  farmaci  biosimilari   come  suggerito  dall’AIFA?   5.  Quali  devono  essere  i  ruoli  della  farmacovigilanza  e  degli  studi  post  markeAng   nel  se>ore  dei  farmaci  biologici  e  biosimilari?  È  sufficiente  quello  che  si  sta   facendo  in  questo  ambito,  o  bisognerebbe  fare  di  più?   DOMANDE CHIAVE   Giampiero  Girolomoni  
3. PSORIASIS  THERAPY   CONTEMPORARY  ISSUES   •  Only  a  porAon  of  paAents  in  need  receive  an  adequate  treatment   •  Treatments  (including  biologics)  are  ineffecAve  in  a  subset  of  paAents   (20-­‐30%)   •  Treatment  loose  efficacy  in  the  long  term  (10-­‐20%  every  year)   •  Not  all  treatment  are  flexible  enough  to  meet  paAents’  specific  needs   •  Therapies  are  not  tolerated  by  a  subset  of  paAents  (20%  of  convenAonal   drugs)   •  Long  term  safety  issues  sAll  very  important   •  Effects  of  therapy  on  co-­‐morbid  disorders  unknown  (MetS,  CDV  disease)     •  Cost  of  therapy   Giampiero  Girolomoni  
4. MOST    PATIENTS  WITH  MODERATE  TO  SEVERE   PSORIASIS  WERE  RECEIVING  NO  TREATMENT  OR   ONLY  TOPICAL  TREATMENT     *  M  Lebwohl,  H  Bachelez,  J  Barker,  G  Girolomoni,  A  Kavanaugh,  R  Langley,  C  Paul,  L  Puig,  K  Reich,  P  van  de  Kerkhof.  Patient Perspectives in the Management of Psoriasis: The Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. J Am Acad Dermatol 2014 May;70(5):871-­‐881 MAPP*  is  a  populaAon-­‐based,  mulAnaAonal  survey  of  3,426  paAents  from  139,948  screened  households   and  781  physicians  in  North  America  and  Europe   Giampiero  Girolomoni  
5. DURATION  OF  SYSTEMIC  TREATMENTS   FOR  PSORIASIS   MTX   FAE   ACI   CSA   Biologics   Safety   Efficacy   Giampiero  Girolomoni  
6. ELEMENTS  TO  CONSIDER  WHEN   SELECTING  A  PSORIASIS  THERAPY   DISEASE     •  Disease  severity   -  ObjecAve  disease  score   -  Emergence  of  new  lesions   -  Skin  areas  involved   -  Frequency  of  relapses   -  Pruritus  or  other  symptoms   •  Comorbidi8es   -  PsoriaAc  arthriAs   -  Cardio-­‐metabolic     co-­‐morbidiAes   -  Psychiatric  co-­‐morbidiAes   PATIENT     -  Age  and  sex   -  Treatment  history   -  Impact  on  QoL   -  Likelihood  of     compliance   -  Pa8ent  expecta8ons   -  Desire  of  remission   -  Fear  of  side  effects   -  Frustra8on  from  previous   therapy   THERAPY     •  Efficacy     -  Short  and  long  term   response  rates   -  Sustained  long-­‐term     efficacy   -  Flexibility   •  Safety   -  Tolerability   -  Long-­‐term  risk–benefit   profile   •  Impact  on  life  style   PaAents  may  underesAmate     disease  severity  and  impact  on   quality  of  life   Giampiero  Girolomoni  
7. OSCAR:  DRUG  SURVIVAL  RATE     FOR  ANTI-­‐TNFΑ  TREATMENTS   Dura8on  of  the  First  Biologic  Treatment,  days   Esposito M et al. Br J Dermatol 2013;169:666-72. Survival  Distribu8on  Func8on   1.00   0.75   0.50   0.25   0.00   0   250   500   750   1000   1250   1500   1750   2000   2250   Etanercept* mean 1534 days: 4.2 yrs; n = 389 Adalimumab mean 960 days: 2.6 yrs; n = 114 Infliximab mean 1108 days: 3.0 yrs; n = 147 Kaplan-­‐Meier  method,  log-­‐rank  test,  and  Cox  regression  analysis   *  P  <  0.01  vs  adalimumab  and/or  infliximab   650  pa8ents  form  Verona,  Bari  and  Rome   Giampiero  Girolomoni  
8. SELECTED  EMERGING  SYSTEMIC  THERAPIES     FOR  PSORIASIS*   Current  drug   name   Trade   name   Company   Target     Efficacy   Brodalumab   Amgen   IL-­‐17  receptor     Mean  PASI  improvement  86%  taking  210  mg  biw  for   12  weeks   Secukinumab     Cosentyx   NovarAs   IL-­‐17A       PASI  75  in  81.6%  at  12  weeks  in  paAents  taking  300   mg  at  weeks  1-­‐4,  8  and  12   Ixekizumab   Eli-­‐Lilly   IL-­‐17A     PASI  75  in  82%  of  paAents  taking  150  mg   Guselkumab   Janssen   IL-­‐23  (p19)   PASI  75  in  100%  at  12  weeks  in  paAents  taking  300   mg  at  weeks  0,  4,  8  and  12   Tildrakizumab   MSD   IL-­‐23  (p19)   PASI  75  in  74%  at  16  weeks  in  paAents  taking  200   mg  at  weeks  0,  4  and  12   TofaciAnib   Xeljanz   Pfizer   JAK1  and  JAK3   PASI  75  in  64%  of  paAents  taking  10  mg  bid  at  16   weeks     BariciAnib   Eli-­‐Lilly   JAK1  and  JAK2   PASI  75  in  65%  of  paAents  taking  8  mg  once  daily   Apremilast   Otezla   Celgene   PDE4   PASI  75  in  41%  in  paAents  taking  30  mg  bid  for  16   weeks   *These  agents  are  not  currently  licensed  for  therapeuAc  use     Giampiero  Girolomoni  
9. CONCLUSIONS   EVOLUTION  IN  THE  TREATMENT  LANDSCAPE  OF  PSORIATIC  DISEASE   •  Psoriasis  very  acAve  field  of  clinical,  laboratory  and  pharmacological  research   •  Many  new  treatments  for  moderate  and  severe  forms  available  in  the  next  few   years   •  Biosimilars  may  represent  a  very  important  opportunity  for  recruiAng  more   paAents  in  need  to  more  effecAve  therapy,  provided  that  efficacy  and  safety  is   adequately  addressed   •  Personalized/straAfied  medicine  very  important  to  maximize  benefit/risk   •  Treatment  strategy  more  directed  by  paAents  needs   Giampiero  Girolomoni