Analysis of Local Treatment-emergent Adverse Events in Patients With CIDP Treated With fSCIG During the ADVANCE-CIDP1 and Long-term ADVANCE-CIDP3 Trials
Ade Ajibade1, Faisal Riaz1, Neil Lamarre2, Damion Nero3, Kimberly Duff4, Erin Greco4, Enrique Garcia4, Hakan Ay4
1Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA, 2Genesis Research Group, Hoboken, NJ, USA, 3Takeda Development Center Americas, Inc., Cambridge, MA, USA (at time of study), 4Takeda Development Center Americas, Inc., Cambridge, MA, USA
Objective:

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).

Background:
fSCIG is approved as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). 
Design/Methods:
This post-hoc analysis evaluated local TEAEs (including infusion-site reactions [ISRs]) and TEAEs of interest (headache and nausea). Adults with CIDP were randomized to fSCIG or placebo for 6 months or until relapse/discontinuation in ADVANCE-CIDP1, a phase 3, double-blind, placebo-controlled trial. Those without relapse could enter ADVANCE-CIDP3, the open-label extension, in which all patients received fSCIG.
Results:

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.

Conclusions:

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

10.1212/WNL.0000000000217021
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