Περίληψη:
This cohort study compares the use of methotrexate vs biologic agents in
children with moderate to severe psoriasis.
Question What is the association between use of methotrexate vs
biologics and psoriasis severity and drug survival (rate and duration of
adherence to a specific drug regimen) in pediatric patients with
moderate to severe psoriasis? Findings In this cohort study including
234 pediatric patients with moderate to severe psoriasis, those
receiving biologics were more likely than those treated with
methotrexate to achieve a Physician Global Assessment status of
clear/almost clear and 75% or more improvement of the Psoriasis Area
and Severity Index rating at 6 months. In addition, biologics were
associated with better drug survival rates at 1, 3, and 5 years, with
comparable discontinuation rates owing to lack of response. Meaning In
pediatric patients with psoriasis, treatment with biologics may be
associated with a significantly greater reduction in psoriasis severity
than methotrexate; nevertheless, with 35.6% of the patients achieving
clear/almost clear and 40.0% reaching 75% or more improvement on the
Psoriasis Area and Severity Index, methotrexate remains an effective
treatment for pediatric psoriasis.
Importance Few studies have compared the use of methotrexate and
biologics, the most commonly used systemic medications for treatment of
moderate to severe psoriasis in children. Objective To assess the
real-world, 6-month reduction in psoriasis severity and long-term drug
survival (rate and duration of adherence to a specific drug) of
methotrexate vs biologics in plaque psoriasis in children. Design,
Setting, and Participants A retrospective medical records review was
conducted at 20 European and North American centers. Treatment response
was based on site-reported Psoriasis Area and Severity Index (PASI)
and/or Physician Global Assessment (PGA) scores at baseline and within
the first 6 months of treatment. Participants included all 234
consecutively seen children with moderate to severe psoriasis who
received at least 3 months of methotrexate or biologics from December 1,
1990, to September 16, 2014, with sufficient data for analysis. Data
analysis was performed from December 14, 2015, to September 1, 2016.
Main Outcomes and Measures PASI, with a range from 0 to 72 (highest
score indicating severe psoriasis), and/or PGA, with a scale of 0
(clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), and 5 (very
severe). Results Of 234 pediatric patients (103 boys [44.0%]; 131
girls [56.0%]) treated with methotrexate and/or biologics, 163
patients (69.7%) exclusively received methotrexate, 47 patients
(20.1%) exclusively received biologics, and 24 children (10.2%)
received methotrexate and biologics sequentially. Of the latter cohort,
23 children were treated initially with methotrexate. Mean (SD) age at
initiation was 11.6 (3.7) years for methotrexate and 13.3 (2.9) years
for biologics (73.2% for etanercept) (P = .002). Among patients
evaluated by a scoring method at 6-month follow-up, 75% or greater
improvement in PASI (PASI75) was achieved in 12 of 30 patients (40.0%)
receiving methotrexate and 20 of 28 patients (71.4%) receiving
biologics, and PGA was clear/almost clear (PGA 0/1) in 41 of 115
patients (35.6%) receiving methotrexate and 18 of 37 patients (48.6%)
receiving biologics. Achieving PASI75 and/or PGA 0/1 between baseline
and 6 months was more likely with biologics than methotrexate (PASI75:
odds ratio [OR], 4.56; 95% CI, 2.02-10.27; P < .001; and PGA 0/1: OR,
2.00; 95% CI, 0.98-4.00; P = .06). Decreased mean PASI and PGA scores
were associated with biologics more than with methotrexate (PASI effect,
-3.13; 95% CI, -4.33 to -1.94; P < .001; and PGA effect, -0.31; 95%
CI, -0.56 to -0.06; P = .02). After 1, 3, and 5 years of use, overall
drug survival rates for methotrexate were 77.5%, 50.3%, and 35.9%,
and for biologics, the rates were 83.4%, 64.3%, and 57.1%,
respectively. Biologics were associated with a better
confounder-corrected drug survival than methotrexate (hazard ratio
[HR], 2.23; 95% CI, 1.21-4.10; P = .01). Discontinuation owing to
lack of response was comparable (HR, 1.64; 95% CI, 0.80-3.36; P = .18).
Conclusions and Relevance Methotrexate and biologics appear to be
associated with improvement in pediatric psoriasis, although biologics
seem to be associated with greater reduction in psoriasis severity
scores and higher drug survival rates than methotrexate in the
real-world setting. Additional studies directly comparing these
medications should be performed for confirmation.
Συγγραφείς:
Bronckers, Inge M. G. J.
Paller, Amy S.
West, Dennis P. and
Lara-Corrales, Irene
Tollefson, Megha M.
Tom, Wynnis L. and
Hogeling, Marcia
Belazarian, Leah
Zachariae, Claus
Mahe,
Emmanuel
Siegfried, Elaine
Blume-Peytavi, Ulrike
Szalai,
Zsuzsanna
Vleugels, Ruth Ann
Holland, Kristen
Murphy, Ruth
and Puig, Lluis
Cordoro, Kelly M.
Lambert, Jo
Alexopoulos,
Alex
Mrowietz, Ulrich
Kievit, Wietske
Seyger, Marieke M. B.
and Psoriasis Investigator Grp
Pediat Dermatology Res Alliance and
European Working Grp Pediat
