Selma Atalay and colleagues investigated in a randomized controlled trial a tight controlled dose reduction strategy of the biologics adalimumab, etanercept and ustekinumab in psoriasis patients.
Psoriasis is an immune-mediated inflammatory skin disease for which various biologics are available. These drugs are important in the management of psoriasis and adalimumab, etanercept and ustekinumab are the most frequently used. However, the long-term immunosuppressive effects of the biologics may not be without risk and biologics are expensive, placing a high financial burden on healthcare system. Therefore, aiming for the lowest effective dose is important. We hypothesized that, when disease activity is monitored intensively while the biologic interval is prolonged stepwise, timely action can be taken to prevent persistent flares. Such treatment strategy will allow physicians to determine the lowest effective dose for the individual patient safely. The aim of this study is to investigate if disease activity guided dose reduction strategy is non-inferior compared to usual care in psoriasis patients. In this trial, patients were randomized into the usual care group (standard dose regimen) and dose reduction group. In the dose reduction group, the dose of the biologics were reduced to 67% and 50% of their original dose. This was achieved by stepwise prolongation of the time between two doses and disease activity was closely monitored. In this study, we found that dose reduction strategy was not non-inferior regarding Psoriasis Area and Severity Index (PASI). However, non-inferiority was demonstrated based on the Dermatology Life Quality Index (DLQI) and 53% of the patients were able to reduce their dose successfully. Dose reduction did not lead to any safety issues nor persistent flares. Disease activity guided dose reduction strategy is expected to have major impact on healthcare expenditures. Therefore, we hope that our present study can form a blue print for dose reduction strategies in new biologics for psoriasis and other chronic inflammatory diseases.
Publication in Jama Dermatology
Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis: A Randomized Clinical Trial. Atalay S, van den Reek JMPA, den Broeder AA, van Vugt LJ, Otero ME, Njoo MD, Mommers JM, Ossenkoppele PM, Koetsier MI, Berends MA, van de Kerkhof PCM, Groenewoud HMM, Kievit W, de Jong EMGJ.