Real-world risks of serious infection, major cardiovascular events, and cancers have been looked at in the observational study, while effectiveness analyses have shed light on predictors, persistence, and drug utilization, among other topics. It’s giving us a huge amount of interesting information, not just on the new drugs, but the older drugs as well.
One of the key lessons from the biologic cohort is that clinical trial outcomes are not representative of real-world patients, Griffiths said, noting that about 30% of the participants would be ineligible for clinical trials due to comorbidities such as diabetes, cancers, and abnormal laboratory values, among other reasons.
By contrast, patients in this real-world data set receiving infliximab had an increased risk of serious infection compared to those receiving non-biologic systemic therapies. I think we probably knew that, but it’s good to see that actually coming out of the registry.
— Christopher Griffiths, MD, FRCP, professor of dermatology at the University of Manchester in the U.K.
Griffiths said in an update on the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) that he presented at the recent World Congress of Dermatology in Milan.
The biologics cohort is the largest of three cohorts in BADBIR, comprising 12,229 of 18,334 patients registered to date at 163 hospital sites in the U.K. and Ireland, while the conventional and small-molecule cohorts now include 5,714 and 321 patients, respectively, according to Griffiths.
In fact, biologics are less effective in clinical trial-ineligible participants, Griffiths said, citing a recent report from the BADBIR Study Group published in JAMA. In that report, BADBIR patients categorized as ineligible for clinical trials had a significantly smaller change in Psoriasis Area and Severity Index (PASI) on treatment with adalimumab or ustekinumab, and had significantly higher rates of serious adverse effects on treatment with adalimumab, ustekinumab, or etanercept.
- Mason KJ, Barker JNWN, Smith CH, et al. Comparison of Drug Discontinuation, Effectiveness, and Safety Between Clinical Trial Eligible and Ineligible Patients in BADBIR. JAMA Dermatol. 2018;154(5):581–588. doi:10.1001/jamadermatol.2018.0183
- Risk of Serious Infection in Patients with Psoriasis Receiving Biologic Therapies: A Prospective Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR).