PMID- 28485816
OWN - NLM
STAT- MEDLINE
DCOM- 20180619
LR  - 20180620
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 31
IP  - 10
DP  - 2017 Oct
TI  - Adverse events associated with discontinuation of the biologics/classic systemic 
      treatments for moderate-to-severe plaque psoriasis: data from the Spanish 
      Biologics Registry, Biobadaderm.
PG  - 1700-1708
LID - 10.1111/jdv.14314 [doi]
AB  - BACKGROUND: Little is known about the adverse events (AEs) that lead to 
      suspension of systemic treatments for psoriasis in clinical practice. OBJECTIVE: 
      The study aimed to investigate AEs associated with discontinuation of systemic 
      therapy in patients with psoriasis in a clinical setting (Biobadaderm). MATERIALS 
      AND METHODS: Multicentre, prospective, cohort study of patients with 
      moderate-to-severe plaque psoriasis receiving systemic therapies from January 
      2008 to November 2015, in 12 hospitals in Spain. The incidence rate (IR) was used 
      to compare biologics and classic systemic therapies. RESULTS: A total of 4218 
      courses of treatment were given to 1938 patients. A total of 447 (11%) treatments 
      were discontinued due to AEs. The IR of AE associated with discontinuation of 
      systemic therapies was 13 events/100 patient-years (PY) (95% CI: 12.14-13.93), 
      9.34 events/100 PY (95% CI: 8.44-10.33) for biologics and 19.67 (95% CI: 
      17.9-21.6) events/100 PY for classics (P < 0.001). Of 810 discontinuation-related 
      AEs, 117 (14%) were serious. The highest IRs were for cyclosporine [49.18/100 PY 
      (95% CI: 41.91-57.72)] and infliximab [26.52/100 PY (95% CI: 20.98-33.51). 
      Ustekinumab presented the lowest IR (2.6/100 PY (95% CI: 1.83-3.69). LIMITATIONS: 
      Observational study with potential selection bias. CONCLUSION: Biologic therapies 
      are associated with a lower rate of discontinuation-related AEs than are classic 
      therapies in real clinical practice. Ustekinumab showed the lowest incidence.
CI  - (c) 2017 European Academy of Dermatology and Venereology.
FAU - Belinchon, I
AU  - Belinchon I
AD  - Hospital General Universitario de Alicante-ISABIAL, Alicante, Spain.
FAU - Ramos, J M
AU  - Ramos JM
AD  - Hospital General Universitario de Alicante-ISABIAL, Alicante, Spain.
FAU - Carretero, G
AU  - Carretero G
AD  - Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, 
      Spain.
FAU - Ferrandiz, C
AU  - Ferrandiz C
AD  - Hospital Universitario Germans Trias i Pujol, Badalona, Spain.
FAU - Rivera, R
AU  - Rivera R
AD  - Hospital Universitario 12 de Octubre, Institute i+12, Medical School, University 
      Complutense, Madrid, Spain.
FAU - Dauden, E
AU  - Dauden E
AD  - Hospital Universitario de la Princesa, IIS-IP, Madrid, Spain.
FAU - De la Cueva-Dobao, P
AU  - De la Cueva-Dobao P
AD  - Hospital Infanta Leonor, Madrid, Spain.
FAU - Gomez-Garcia, F J
AU  - Gomez-Garcia FJ
AD  - Hospital Universitario Reina Sofia, Cordoba, Spain.
FAU - Herrera-Ceballos, E
AU  - Herrera-Ceballos E
AD  - Hospital Universitario Virgen de la Victoria, Malaga, Spain.
FAU - Sanchez-Carazo, J L
AU  - Sanchez-Carazo JL
AD  - Hospital General Universitario de Valencia, Valencia, Spain.
FAU - Lopez-Estebaranz, J L
AU  - Lopez-Estebaranz JL
AD  - Hospital Universitario Fundacion Alcorcon, Madrid, Spain.
FAU - Alsina, M
AU  - Alsina M
AD  - Hospital Clinic de Barcelona, Barcelona, Spain.
FAU - Ferran, M
AU  - Ferran M
AD  - Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.
FAU - Torrado, R
AU  - Torrado R
AD  - Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, 
      Spain.
FAU - Carrascosa, J M
AU  - Carrascosa JM
AD  - Hospital Universitario Germans Trias i Pujol, Badalona, Spain.
FAU - Llamas-Velasco, M
AU  - Llamas-Velasco M
AD  - Hospital Universitario de la Princesa, IIS-IP, Madrid, Spain.
FAU - Ortiz, P L
AU  - Ortiz PL
AD  - Hospital Universitario 12 de Octubre, Institute i+12, Medical School, University 
      Complutense, Madrid, Spain.
FAU - Garcia-Doval, I
AU  - Garcia-Doval I
AD  - Research Unit, Fundacion Piel Sana Academia Espanola de Dermatologia y 
      Venereologia, Madrid, Spain.
AD  - Complexo Hospitalario Universitario de Vigo, Vigo, Spain.
FAU - Descalzo, M A
AU  - Descalzo MA
AD  - Research Unit, Fundacion Piel Sana Academia Espanola de Dermatologia y 
      Venereologia, Madrid, Spain.
CN  - Biobadaderm Study Group
LA  - eng
SI  - GENBANK/NCT02075697
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170606
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Biological Products)
RN  - 0 (Dermatologic Agents)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Biological Products/*adverse effects
MH  - Dermatologic Agents/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Psoriasis/*drug therapy
MH  - Registries
MH  - Severity of Illness Index
MH  - Spain
MH  - Substance Withdrawal Syndrome/*physiopathology
EDAT- 2017/05/10 06:00
MHDA- 2018/06/21 06:00
CRDT- 2017/05/10 06:00
PHST- 2017/03/08 00:00 [received]
PHST- 2017/04/12 00:00 [accepted]
PHST- 2017/05/10 06:00 [pubmed]
PHST- 2018/06/21 06:00 [medline]
PHST- 2017/05/10 06:00 [entrez]
AID - 10.1111/jdv.14314 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1700-1708. doi: 10.1111/jdv.14314. 
      Epub 2017 Jun 6.