To assess the incidence of local treatment-emergent adverse events (TEAEs) with hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) during the ADVANCE-CIDP1/CIDP3 trials (NCT02549170/NCT02955355).

In ADVANCE-CIDP1 (n=62) and ADVANCE-CIDP3 (n=85), baseline age (mean [SD]) was 55 (14.3) and 54 (13.1) years, and 58.1% and 54.1% of patients were male, respectively. In ADVANCE-CIDP1, 141 local TEAEs were reported for 600 fSCIG infusions in 24 patients (38.7%; 0.24 events/infusion) over the 6-month treatment period. In ADVANCE-CIDP3, there were 524 local TEAEs for 3487 fSCIG infusions in 30 patients (35.3%; 0.15 events/infusion) over a median (range) exposure duration of 33.1 (0-77.3) months. Local TEAEs were all mild/moderate in ADVANCE-CIDP1 (events, patients [%], events/infusion: mild, 124, 23 [37.1%], 0.21; moderate, 17, 7 [11.3%], 0.03), and mostly mild/moderate in ADVANCE-CIDP3 (mild, 464, 28 [32.9%], 0.13; moderate, 41, 9 [10.6%], 0.01; severe, 19, 1 [1.2%], <0.01). In ADVANCE-CIDP1, the incidence of treatment-related local TEAEs with fSCIG tended to decrease during the study (patients with ≥1 event per infusion: 27.4% [first infusion] to <10% [tenth infusion]); a similar trend was observed in ADVANCE-CIDP3. The incidences of pain/pruritus ISRs plateaued at <10% of patients/infusion in ADVANCE-CIDP1, and <5% of patients/infusion in ADVANCE-CIDP3. Headache and nausea were mild/moderate in both trials, except for two patients (2.4%) with severe headache in ADVANCE-CIDP3.

This post-hoc analysis provides further support for the favorable long-term safety and tolerability profile of fSCIG in adults with CIDP.