Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis
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Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. / Egeberg, A; Ottosen, M B; Gniadecki, R; Broesby-Olsen, S; Dam, T N; Bryld, L E; Rasmussen, M K; Skov, L.
In: British Journal of Dermatology, Vol. 178, No. 2, 2018, p. 509-519.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis
AU - Egeberg, A
AU - Ottosen, M B
AU - Gniadecki, R
AU - Broesby-Olsen, S
AU - Dam, T N
AU - Bryld, L E
AU - Rasmussen, M K
AU - Skov, L
N1 - © 2017 British Association of Dermatologists.
PY - 2018
Y1 - 2018
N2 - BACKGROUND: Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking.OBJECTIVES: To examine safety, efficacy and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima).METHODS: The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics. We examined patients treated between 1 January 2007 and 31 March 2017. We used Kaplan-Meier survival curves and Cox regression to examine drug survival patterns.RESULTS: A total of 3495 treatment series (2161 patients) were included (adalimumab n = 1332; etanercept n = 579; infliximab n = 333; ustekinumab n = 1055 and secukinumab n = 196). Secukinumab had the highest number of PASI 100 (100% improvement from baseline Psoriasis Area and Severity Index) respondents, but also the lowest drug survival among all the biologics. Ustekinumab had the highest drug survival overall. There were no significant differences in discontinuation risk between originator and biosimilar versions of infliximab or etanercept. Treatment with higher than approved dosages was frequent for all drugs except for adalimumab and secukinumab. Adverse events (predominantly infections) were most frequent for secukinumab compared with the other agents.CONCLUSIONS: Ustekinumab was associated with the highest drug survival, and secukinumab with the lowest, although most patients on secukinumab were non-naïve. Switching from originator to biosimilar had no significant impact on drug survival, and the safety profiles were comparable. Adverse events occurred most frequently with secukinumab. Future studies are warranted to assess the long-term safety of novel biologics for psoriasis.
AB - BACKGROUND: Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking.OBJECTIVES: To examine safety, efficacy and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima).METHODS: The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics. We examined patients treated between 1 January 2007 and 31 March 2017. We used Kaplan-Meier survival curves and Cox regression to examine drug survival patterns.RESULTS: A total of 3495 treatment series (2161 patients) were included (adalimumab n = 1332; etanercept n = 579; infliximab n = 333; ustekinumab n = 1055 and secukinumab n = 196). Secukinumab had the highest number of PASI 100 (100% improvement from baseline Psoriasis Area and Severity Index) respondents, but also the lowest drug survival among all the biologics. Ustekinumab had the highest drug survival overall. There were no significant differences in discontinuation risk between originator and biosimilar versions of infliximab or etanercept. Treatment with higher than approved dosages was frequent for all drugs except for adalimumab and secukinumab. Adverse events (predominantly infections) were most frequent for secukinumab compared with the other agents.CONCLUSIONS: Ustekinumab was associated with the highest drug survival, and secukinumab with the lowest, although most patients on secukinumab were non-naïve. Switching from originator to biosimilar had no significant impact on drug survival, and the safety profiles were comparable. Adverse events occurred most frequently with secukinumab. Future studies are warranted to assess the long-term safety of novel biologics for psoriasis.
KW - Biological Factors/therapeutic use
KW - Biosimilar Pharmaceuticals/therapeutic use
KW - Denmark
KW - Dermatologic Agents/therapeutic use
KW - Drug Stability
KW - Female
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Psoriasis/drug therapy
KW - Registries
KW - Treatment Outcome
U2 - 10.1111/bjd.16102
DO - 10.1111/bjd.16102
M3 - Journal article
C2 - 29094341
VL - 178
SP - 509
EP - 519
JO - British Journal of Dermatology
JF - British Journal of Dermatology
SN - 0007-0963
IS - 2
ER -
ID: 221760367