Contributions
Abstract: P1159
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Natalizumab (NAT) and Fingolimod (FTY) are approved in the European Union for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). Recently, substantial comparative real world evidence has emerged. This systematic literature review aimed to identify observational studies that directly compare NAT to FTY in RRMS.
Methods: A protocol pre-specified search of 14 databases and 12 conference proceedings was conducted to identify relevant published or unpublished comparative evidence between FTY and NAT. The search focused on adult patients with RRMS, unrestricted by date or language. Screening and data extraction were carried out by two independent reviewers. Study quality was assessed using the Downs and Black instrument.
Results: In total, 2,360 titles were retrieved. After review, we included 17 studies (7,565 participants analysed); two multinational studies, two US and 13 in Europe. Study sizes ranged from 33 to 2,095; four studies included fewer than 100 participants for analysis and only one had more than 1,000 participants. Sixteen studies used parallel design and one used crossover design. Thirteen studies controlled for baseline patient characteristics, 7/13 used propensity score matching, and 8/13 used multivariable regression models. Data was sourced from: claims databases (2 studies), MSBase registry (2 studies), national MS registers (3 studies) and clinical databases (10 studies). Endpoints:
1) Annualized relapse rates: Two out of six studies reported significantly favourable results for NAT in comparison to FTY.
2) Time to first relapse: Two out of five studies reported significantly longer times for NAT than for FTY.
3) Reduction in confirmed disability progression: One out of nine studies reported significantly better results for NAT.
4) Confirmed disability improvement: Three out of six studies reported significantly favourable results for NAT. No study reported superiority of FTY compared to NAT for any endpoint.
Conclusions: Preliminary evidence from 17 studies favoured NAT over FTY. For each endpoint assessed ≥1 study showed statistically significant results favouring natalizumab, while no studies showed statistically significant results favouring fingolimod on any endpoint. Considerable variability in design and results existed amongst these published studies.
Disclosure:
SL, RW: Employees of Kleijnen Systematic Reviews Ltd, paid consultants for Biogen.
PA: received honoraria for lecturing and participation in advisory boards, travel expenses for attending congresses and meetings from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva.
DB: in the last 3 years, received personal compensations for advisory boards, travel grants, and financial support for editorial publications from Almirall, Sanofi-Genzyme, Merck, Novartis, and Teva.
TK: Scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.
NKH: Received honoraria for lecturing and participation in advisory councils, travel expenses for attending congresses and meetings from Bayer-Schering, Merck Serono, Biogen Idec, Teva Pharmaceutical Industries, Sanofi-Avensis, and Novartis.
DL: Consulting/advisor fees, honoraria, and research support from Novartis, Biogen, Roche and Merck
CA: full-time employee of and stockholder in Biogen.
This study was supported by Biogen (Cambridge, MA, USA). Writing and editorial support was provided by Kleijnen Systematic Reviews Ltd, York, UK. The authors acknowledge the support of Steven Duffy (Kleijnen Systematic Reviews Ltd).
Abstract: P1159
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Natalizumab (NAT) and Fingolimod (FTY) are approved in the European Union for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). Recently, substantial comparative real world evidence has emerged. This systematic literature review aimed to identify observational studies that directly compare NAT to FTY in RRMS.
Methods: A protocol pre-specified search of 14 databases and 12 conference proceedings was conducted to identify relevant published or unpublished comparative evidence between FTY and NAT. The search focused on adult patients with RRMS, unrestricted by date or language. Screening and data extraction were carried out by two independent reviewers. Study quality was assessed using the Downs and Black instrument.
Results: In total, 2,360 titles were retrieved. After review, we included 17 studies (7,565 participants analysed); two multinational studies, two US and 13 in Europe. Study sizes ranged from 33 to 2,095; four studies included fewer than 100 participants for analysis and only one had more than 1,000 participants. Sixteen studies used parallel design and one used crossover design. Thirteen studies controlled for baseline patient characteristics, 7/13 used propensity score matching, and 8/13 used multivariable regression models. Data was sourced from: claims databases (2 studies), MSBase registry (2 studies), national MS registers (3 studies) and clinical databases (10 studies). Endpoints:
1) Annualized relapse rates: Two out of six studies reported significantly favourable results for NAT in comparison to FTY.
2) Time to first relapse: Two out of five studies reported significantly longer times for NAT than for FTY.
3) Reduction in confirmed disability progression: One out of nine studies reported significantly better results for NAT.
4) Confirmed disability improvement: Three out of six studies reported significantly favourable results for NAT. No study reported superiority of FTY compared to NAT for any endpoint.
Conclusions: Preliminary evidence from 17 studies favoured NAT over FTY. For each endpoint assessed ≥1 study showed statistically significant results favouring natalizumab, while no studies showed statistically significant results favouring fingolimod on any endpoint. Considerable variability in design and results existed amongst these published studies.
Disclosure:
SL, RW: Employees of Kleijnen Systematic Reviews Ltd, paid consultants for Biogen.
PA: received honoraria for lecturing and participation in advisory boards, travel expenses for attending congresses and meetings from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi-Aventis, and Teva.
DB: in the last 3 years, received personal compensations for advisory boards, travel grants, and financial support for editorial publications from Almirall, Sanofi-Genzyme, Merck, Novartis, and Teva.
TK: Scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.
NKH: Received honoraria for lecturing and participation in advisory councils, travel expenses for attending congresses and meetings from Bayer-Schering, Merck Serono, Biogen Idec, Teva Pharmaceutical Industries, Sanofi-Avensis, and Novartis.
DL: Consulting/advisor fees, honoraria, and research support from Novartis, Biogen, Roche and Merck
CA: full-time employee of and stockholder in Biogen.
This study was supported by Biogen (Cambridge, MA, USA). Writing and editorial support was provided by Kleijnen Systematic Reviews Ltd, York, UK. The authors acknowledge the support of Steven Duffy (Kleijnen Systematic Reviews Ltd).