Patients with psoriasis who are categorized as ineligible for clinical trials based on the British Association of Dermatologists Biologics Intervention Register (BADBIR) experienced lower effectiveness and higher rates of serious adverse events (SAEs) while being treated with biologic therapy compared with those identified as eligible, according to the results of an observational study published in JAMA Dermatology.
The investigators sought to determine whether drug discontinuation, effectiveness, and rates of SAEs differed between patients with psoriasis who are identified as being eligible or ineligible for clinical trials.
Eligibility criteria for clinical trials of biologic therapies for psoriasis were determined in patients from 157 dermatology centers in the United Kingdom who were participating in the BADBIR and were receiving biologic medications as part of standard care. Patients evaluated were being treated with etanercept (n=1509), adalimumab (n=4000), and ustekinumab (n=1627), and underwent ≥1 follow-up visit.
Patients in BADBIR with a missing baseline Psoriasis Area and Severity Index (PASI) or baseline PASI score <10 (with etanercept) or <12 (with adalimumab and adalimumab), who would otherwise be considered eligible, were assessed separately. Eligibility categories in BADBIR included the following: eligible, ineligible, insufficient baseline PASI only, and missing baseline PASI only.
Among the 7136 patients who were analyzed, the mean age was 45±13 years; 41% were women. Of the 7136 patients, 56% (n=839) of etanercept, 56% (n=2219) of adalimumab, and 46% (n=754) of ustekinumab registrations were categorized as eligible. The most frequent reasons for ineligibility included diabetes and nonchronic plaque psoriasis.
Patients who were categorized as ineligible (etanercept, 24% [n=367]; adalimumab, 7% [n=282]; ustekinumab, 24% [n=394]) achieved a smaller absolute change in PASI after 6 and 12 months (adalimumab and ustekinumab) and also had significantly higher rates of SAEs vs those categorized as eligible (etanercept: incidence rate ratio [IRR] 1.9; 95% CI, 1.4-2.6; adalimumab: IRR 2.0; 95% CI, 1.5-2.6; ustekinumab: IRR 2.8; 95% CI, 2.1-3.8). There were no significant differences in drug discontinuation rates reported between eligible vs ineligible patients.
The investigators concluded that clinical trial effectiveness and safety outcomes of biologic therapies for psoriasis do not represent real-world patients, especially those categorized as ineligible in the current study and who would have been excluded from all such trials. Clinicians should be aware of these differences when counseling patients about initiation of biologic therapy based on clinical trial evidence.
Mason KJ, Barker JNWN, Smith CH, et al; BADBIR Study Group. Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR [published online March 28, 2018]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.0183