Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

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 - 2018/2/1

Y1 - 2018/2/1

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

SN - 0007-0963

VL - 178

SP - 509

EP - 519

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 2

ER -