Panzyga® for your patients with CIDP

Trial overview5,6

*Patients were screened, and, if eligible, entered the wash-out phase, during which their current medication was reduced in a predefined standard manner, to determine whether they had active CIDP. For those previously on IVIg, the dose was reduced by 25% at each sequential infusion until deterioration. For those previously on corticosteroids, the dose was reduced at the discretion of the investigator at a rate to expect study entry within 6–12 weeks and to a dose of prednisolone ≤20 mg/day or equivalent when deterioration occurred. Low doses of corticosteroids at deterioration could be continued during the study.5,6
†Including patients with MADSAM or pure motor CIDP.5,6

‡ Patients deteriorating after Week 18 or 21 dropped out and had their end of study visit at Week 21 or 24, respectively. Patients in the 2g/kg arm were discontinued from the study if they were stable (unimproved) at Week 6 or deteriorated after Week 3 and before Week 21.5,6

§ A responder was defined as a subject who showed an improvement (decrease) ≥ 1 point in adjusted INCAT score at Week 6 compared with baseline (first visit of the Dose-evaluation Phase), completed the 24-week study, and maintained the response at Week 24.5,6
EFNS/PNS, European Federation of Neurological Societies and Peripheral Nerve Society; INCAT, inflammatory neuropathy cause and treatment (INCAT) disability score; MADSAM, multifocal acquired demyelinating sensory and motor neuropathy.

Efficacy

Proven efficacy as maintenance therapy with high response rates.6

By the end of the study, around 80% of patients receiving panzyga^® maintenance treatment at 1.0 g/kg showed an improvement in arm and leg disability of 1 point or more, as measured by adjusted INCAT score.6
Efficacy was supported by the proportion of responders in the 0.5 g/kg and 2.0 g/kg dose arms in the adjusted INCAT disability score. In addition, a high proportion of patients showed improvements in the ability to perform daily activities, as measured by the inflammatory Rasch-built Overall Disability Scale (I-RODS), and in muscle strength as measured by the Medical Research Council (MRC) sum scores and grip strength.6

*The lower CI limit of 69% exceeded the predefined threshold of 42%, thus the primary endpoint was met.6
CI, confidence interval; INCAT, inflammatory neuropathy cause and treatment (INCAT) disability score; I-RODS, inflammatory Rasch-built overall disability scale; MRC, Medical Research Council.

†A responder was defined as a subject who showed an improvement (decrease) ≥ 1 point in adjusted INCAT score at Week 6 compared with baseline (first visit of the Dose-evaluation Phase), completed the 24-week study, and maintained the response at Week 24.6

Tolerability

Safety profile consistent with what expected for IVIg products6

The incidence of related treatment-emergent adverse events (TEAEs) was similar across all groups.6

The only TEAE where a dose effect was apparent was headache, with an incidence of 2.9% in the 0.5 g/kg group, 14.5% in the 1.0 g/kg group, and 23.7% in the 2.0 g/kg group.6
The evaluation of safety and tolerability parameters showed that administration of IVIg in the ProCID study was safe in patients with CIDP. In a largely IVIg-naïve patient population, the profle of TEAEs was as expected for IVIg products. Headache was the only dose-dependent TEAE.7

References

1. Briani C, et al. Neurol Sci 2022;43(Suppl 2):605–614;

2. Lehmann HC, et al. J Neurol Neurosurg Psychiatry 2019;90:981–987;

3. Van den Bergh PYK, et al. J Peripher Nerv Syst 2021;26:242–268;

4. Querol L, et al. J Neurol 2021;268:3706–3716.

5. Cornblath DR, et al. J Peripher Nerv Syst 2018;23:108–114;

6. Cornblath DR, et al. Brain 2022;145:887–896.

7. Cornblath DR, et al. Drug Saf 2023;46:835–845.