New publication: Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial

Biopharmaceuticals, such as monoclonal antibodies (mAbs), are used in the treatment of many chronic and life-threatening diseases. Degradation and ineffective absorption of mAbs in the gastrointestinal tract, due to molecular size and conditions such as low pH and digestive enzymes, necessitates their parenteral administration. However, in clinical practice, treatments administered using subcutaneous (s.c.) injection of mAbs are often perceived as unpleasant and painful, especially during long-term use. Intradermal (i.d.) administration through hollow microneedles is advocated as a substitute for s.c. injection, as it is perceived to be less painful and it potentially has more favourable pharmacokinetics. 

In order to compare i.d. administration of a mAb using a hollow microneedle with s.c. injection using a conventional hypodermic needle, an unbiased and systematic approach is warranted to acquire reliable data on pain perception and patient preferences, as these are subjective concepts. Therefore, it is relevant to compare pain, acceptability and local tolerability, as well as PK and pharmacodynamics (PD).

In a recently published paper, CHDR in close collaboration with LUMC, LACDR and Sanquin systematically and comprehensively characterized i.d. administration of model mAb adalimumab using hollow microneedles compared to s.c. injection using a conventional needle. Read about it here