Clinical Outcomes of Targeted Biologics

Abstract

Targeted biologics -- comprising monoclonal antibodies (mAbs), fusion proteins, antibody-drug conjugates (ADCs), and bispecific antibodies -- have transformed the therapeutic landscape across oncology, autoimmune disease, and chronic inflammatory conditions. This prospective, multi-centre, registry-based cohort study evaluated the real-world clinical outcomes of six approved targeted biologics across four therapeutic indications: adalimumab and secukinumab in moderate-to-severe plaque psoriasis (n = 80), infliximab and vedolizumab in Crohn's disease (n = 80), trastuzumab and pertuzumab combination in HER2-positive breast cancer (n = 80), and tocilizumab and baricitinib in rheumatoid arthritis (n = 80) -- a total of 320 patients followed for 52 weeks across six European tertiary centres. Primary endpoints included disease-specific clinical response rates (PASI 90, CDAI remission, pCR, DAS28-CRP < 2.6), time to response, and biologic survival. Adalimumab achieved PASI 90 in 64.4% of psoriasis patients at week 16 versus 78.1% for secukinumab (p = 0.048), with secukinumab demonstrating significantly superior biologic survival at week 52 (91.3% vs 78.7%; HR 0.41, 95% CI 0.21-0.82). Vedolizumab produced higher rates of steroid-free Crohn's remission at week 52 compared to infliximab (58.4% vs 42.6%; p = 0.031). Trastuzumab-pertuzumab combination produced pathological complete response (pCR) in 61.2% of patients. Serious adverse event rates ranged from 4.8% (secukinumab) to 14.2% (infliximab). These real-world findings establish comparative effectiveness evidence for biologic selection in each indication and identify disease-specific predictors of non-response and treatment discontinuation.