The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Leonoor Wijnans; Coralie Lecomte; Corinne de Vries; Daniel Weibel; Cormac Sammon; Anders Hviid; Henrik Svanström; Ditte Mølgaard-Nielsen; Harald Heijbel; Lisen Arnheim Dahlström; Jonas Hallgren; Par Sparen; Poul Jennum; Mees Mosseveld; Martijn Schuemie; Nicoline van der Maas; Markku Partinen; Silvana Romio; Francesco Trotta; Carmela Santuccio; Angelo Menna; Giuseppe Plazzi; Keivan Kaveh Moghadam; Salvatore Ferro; Gert Jan Lammers; Sebastiaan Overeem; Kari Johansen; Piotr Kramarz; Jan Bonhoeffer; Miriam C J M Sturkenboom

doi:10.1016/j.vaccine.2012.12.015

The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

Leonoor Wijnans, Coralie Lecomte, Corinne de Vries, Daniel Weibel, Cormac Sammon, Anders Hviid, Henrik Svanström, Ditte Mølgaard-Nielsen, Harald Heijbel, Lisen Arnheim Dahlström, Jonas Hallgren, Par Sparen, Poul Jennum, Mees Mosseveld, Martijn Schuemie, Nicoline van der Maas, Markku Partinen, Silvana Romio, Francesco Trotta, Carmela SantuccioAngelo Menna, Giuseppe Plazzi, Keivan Kaveh Moghadam, Salvatore Ferro, Gert Jan Lammers, Sebastiaan Overeem, Kari Johansen, Piotr Kramarz, Jan Bonhoeffer, Miriam C J M Sturkenboom

151 Citations (Scopus)

Abstract

Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

Original language	English
Journal	Vaccine
Volume	31
Issue number	8
Pages (from-to)	1246-54
Number of pages	9
ISSN	0264-410X
DOIs	https://doi.org/10.1016/j.vaccine.2012.12.015
Publication status	Published - 6 Feb 2013

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Wijnans, L., Lecomte, C., de Vries, C., Weibel, D., Sammon, C., Hviid, A., Svanström, H., Mølgaard-Nielsen, D., Heijbel, H., Dahlström, L. A., Hallgren, J., Sparen, P., Jennum, P., Mosseveld, M., Schuemie, M., van der Maas, N., Partinen, M., Romio, S., Trotta, F., ... Sturkenboom, M. C. J. M. (2013). The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine, 31(8), 1246-54. https://doi.org/10.1016/j.vaccine.2012.12.015

Wijnans, L, Lecomte, C, de Vries, C, Weibel, D, Sammon, C, Hviid, A, Svanström, H, Mølgaard-Nielsen, D, Heijbel, H, Dahlström, LA, Hallgren, J, Sparen, P, Jennum, P, Mosseveld, M, Schuemie, M, van der Maas, N, Partinen, M, Romio, S, Trotta, F, Santuccio, C, Menna, A, Plazzi, G, Moghadam, KK, Ferro, S, Lammers, GJ, Overeem, S, Johansen, K, Kramarz, P, Bonhoeffer, J & Sturkenboom, MCJM 2013, 'The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns', Vaccine, vol. 31, no. 8, pp. 1246-54. https://doi.org/10.1016/j.vaccine.2012.12.015

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title = "The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns",

abstract = "Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.",

author = "Leonoor Wijnans and Coralie Lecomte and {de Vries}, Corinne and Daniel Weibel and Cormac Sammon and Anders Hviid and Henrik Svanstr{\"o}m and Ditte M{\o}lgaard-Nielsen and Harald Heijbel and Dahlstr{\"o}m, {Lisen Arnheim} and Jonas Hallgren and Par Sparen and Poul Jennum and Mees Mosseveld and Martijn Schuemie and {van der Maas}, Nicoline and Markku Partinen and Silvana Romio and Francesco Trotta and Carmela Santuccio and Angelo Menna and Giuseppe Plazzi and Moghadam, {Keivan Kaveh} and Salvatore Ferro and Lammers, {Gert Jan} and Sebastiaan Overeem and Kari Johansen and Piotr Kramarz and Jan Bonhoeffer and Sturkenboom, {Miriam C J M}",

year = "2013",

month = feb,

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doi = "10.1016/j.vaccine.2012.12.015",

language = "English",

volume = "31",

pages = "1246--54",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier",

number = "8",

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TY - JOUR

T1 - The incidence of narcolepsy in Europe

T2 - Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

AU - Wijnans, Leonoor

AU - Lecomte, Coralie

AU - de Vries, Corinne

AU - Weibel, Daniel

AU - Sammon, Cormac

AU - Hviid, Anders

AU - Svanström, Henrik

AU - Mølgaard-Nielsen, Ditte

AU - Heijbel, Harald

AU - Dahlström, Lisen Arnheim

AU - Hallgren, Jonas

AU - Sparen, Par

AU - Jennum, Poul

AU - Mosseveld, Mees

AU - Schuemie, Martijn

AU - van der Maas, Nicoline

AU - Partinen, Markku

AU - Romio, Silvana

AU - Trotta, Francesco

AU - Santuccio, Carmela

AU - Menna, Angelo

AU - Plazzi, Giuseppe

AU - Moghadam, Keivan Kaveh

AU - Ferro, Salvatore

AU - Lammers, Gert Jan

AU - Overeem, Sebastiaan

AU - Johansen, Kari

AU - Kramarz, Piotr

AU - Bonhoeffer, Jan

AU - Sturkenboom, Miriam C J M

PY - 2013/2/6

Y1 - 2013/2/6

N2 - Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

AB - Background: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. Methods: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. Results: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. Conclusions: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

U2 - 10.1016/j.vaccine.2012.12.015

DO - 10.1016/j.vaccine.2012.12.015

M3 - Journal article

SN - 0264-410X

VL - 31

SP - 1246

EP - 1254

JO - Vaccine

JF - Vaccine

IS - 8

ER -

The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

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