Background: Natalizumab is labelled by EMEA (A) as second line in relapsing remitting multiple sclerosis (RRMS) in non-responders to -interferon, and (B) as first line in more aggressive RRMS. Italian Medicines Agency (AIFA), accordingly to a neurological expert panel, established more restrictive criteria to dispense and reimburse natalizumab, and organised a national registry for monitoring its safety. Objectives: To assess risks associated with natalizumab after 1 year since its marketing in Italy, and to compare the Italian Registry data with the characteristics of RCT AFFIRM patients. Methods: Patients under treatment with natalizumab were enrolled into a web-based registry available on AIFA website. It contains electronic forms on: patient eligibility, follow-up during the therapy (to fill every 3 months), drug withdrawal, ADR report, and follow-up after drug withdrawal (to fill every 6 months). It has been active since January 2007. Data up to January 2008 were collected and analysed. Results: Ninety-six MS Centres have enrolled at least one patient. Overall, 696 pts (67% females) were treated: 91% as non-responders to -interferon (A), and 9% with aggressive RRMS (B). Patient baseline disease was more serious compared to AFFIRM: annual relapses were 2.31.0 (average SD) in A pts and 3.51.3 in B pts vs 1.50.9 in AFFIRM pts; EDSS disability was 3.71.5 in A pts and 3.71.4 in B pts vs 2.31.2 in AFFIRM pts. Main pts (53%) received 1–4 drug doses. For 371 pts, at least 1 follow-up was recorded and 78 pts had at least 1 ADR. Hundred ADRs were recorded and 29% were infections. Drug effectiveness in terms of EDSS on 270 pts with 4 to 9 months therapy showed improvements in 49% of cases. Conclusions: Data on ADRs were consistent with available evidences. The national registry appears a useful tool to closely monitor a drug with critical safety profile.
Piccinni C., Periotto L., Addis A., Amato M.P., Mancardi G.L., Poluzzi E., et al. (2008). The Italian Natalizumab Registry: a 1-year follow-up. Chichester : Wiley Blackewell.
The Italian Natalizumab Registry: a 1-year follow-up
PICCINNI, CARLO;POLUZZI, ELISABETTA;MONTANARO, NICOLA
2008
Abstract
Background: Natalizumab is labelled by EMEA (A) as second line in relapsing remitting multiple sclerosis (RRMS) in non-responders to -interferon, and (B) as first line in more aggressive RRMS. Italian Medicines Agency (AIFA), accordingly to a neurological expert panel, established more restrictive criteria to dispense and reimburse natalizumab, and organised a national registry for monitoring its safety. Objectives: To assess risks associated with natalizumab after 1 year since its marketing in Italy, and to compare the Italian Registry data with the characteristics of RCT AFFIRM patients. Methods: Patients under treatment with natalizumab were enrolled into a web-based registry available on AIFA website. It contains electronic forms on: patient eligibility, follow-up during the therapy (to fill every 3 months), drug withdrawal, ADR report, and follow-up after drug withdrawal (to fill every 6 months). It has been active since January 2007. Data up to January 2008 were collected and analysed. Results: Ninety-six MS Centres have enrolled at least one patient. Overall, 696 pts (67% females) were treated: 91% as non-responders to -interferon (A), and 9% with aggressive RRMS (B). Patient baseline disease was more serious compared to AFFIRM: annual relapses were 2.31.0 (average SD) in A pts and 3.51.3 in B pts vs 1.50.9 in AFFIRM pts; EDSS disability was 3.71.5 in A pts and 3.71.4 in B pts vs 2.31.2 in AFFIRM pts. Main pts (53%) received 1–4 drug doses. For 371 pts, at least 1 follow-up was recorded and 78 pts had at least 1 ADR. Hundred ADRs were recorded and 29% were infections. Drug effectiveness in terms of EDSS on 270 pts with 4 to 9 months therapy showed improvements in 49% of cases. Conclusions: Data on ADRs were consistent with available evidences. The national registry appears a useful tool to closely monitor a drug with critical safety profile.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
