Adalimumab delivers consistent benefit in plaque psoriasis, with or without methotrexate

Treatment outcomes with adalimumab for plaque psoriasis appear to be similar between patients on monotherapy and those receiving concomitant methotrexate, according to the BSTOP study.

BSTOP was a target trial emulation cohort study wherein researchers used the British Association of Dermatologists Biologics and Immunomodulators Register. A total of 1,784 patients (42.3 percent female) were included, of which 231 (median age 43.7 years) were in the intervention group that received adalimumab 40 mg every other week plus methotrexate weekly (dosage as determined by the clinician) and 1,553 (median age 43.6 years) were in the comparator group that received adalimumab 40 mg every other week as a monotherapy.

Adalimumab survival function at 1 year was compared between the intervention and comparator groups and set as the primary outcome. Secondary outcomes included differences in adalimumab survival function at 3 years, 75 percent reduction in Psoriasis Area and Severity Index (PASI75) at 1 year and 3 years, serious adverse events at 1 and 3 years, and adalimumab concentrations and antidrug antibodies at 1 year.

Drug survival at 1 year was 79.1 percent in the intervention group vs 78.1 percent in the comparator group, with no evidence of difference (1.0 percent, 95 percent confidence interval [CI], −7.0 to 8.9).

PASI75 at 1 year and 3 years was 49.4 percent and 37.2 percent, respectively, in the intervention group vs 52.0 percent and 32.4 percent, respectively, in the comparator group. The corresponding difference in PASI75 at 1 year (−2.5 percent, 95 percent CI, −21.0 to 15.9) and 3 years (4.9 percent, 95 percent CI, −16.1 to 25.7) was not significant.

Likewise, no differences were seen in the incidence of serious adverse events and adalimumab concentrations between the two treatment groups. However, the intervention group had a lower antidrug antibody level compared with the comparator group (risk difference, −123.7 AU/mL, 95 percent CI, −200.5 to −46.9).