Randomised controlled studies in CIDP published in 2015–2018
Study | Intervention | Design | Patients (n) | Primary endpoint | Results | Duration | References |
PATH | SCIg (2 dosage levels) vs placebo | Randomised controlled, double-blind | Definite or probable CIDP, IVIg-responsive, n=172 | Proportion with relapse or withdrawn for other reason | 63% on placebo, 39% on low-dose SCIg and 33% on high-dose SCIg (p=0.0007) | 24 weeks | 62 |
FORCIDP | Fingolimod vs placebo | Randomised, controlled, double-blind, | Definite or probable CIDP, n=106 | Time to worsening (≥1 adjusted INCAT score) | Ended for futility, fingolimod (42%) vs placebo (43%) | Flexible | 66 |
Lieker et al | IA vs PE | Randomised, controlled, not blinded | CIDP, n=18 of 20 | Improvement in adjusted INCAT score and MRCss | IA: 6/9 vs PE: 4/9 | 6 sessions | 65 |
Danish CIDP and MMN study group | SCIg vs IVIg | Randomised, controlled, crossover, single-blinded | Definite CIDP (EFNS/PNS), n=20 | cIKS | cIKS 7.4 (SCIg) vs 6.9 (IVIg) (p=0.80) | 20 weeks (10/treatment) | 63 |
CIDP, chronic inflammatory demyelinating polyneuropathy; EFNS/PNS, European Federation of Neurological Societies and the Peripheral Nerve Society; IA, immunoadsorption; IVIg, intravenous immunoglobulin; MMN, Multifocal motor neuropathy; MRCss, Medical Research Council sum score; PE, plasma exchange; SCIg, subcutaneous immunoglobulin; cIKS, combined isokinetic muscle strength.