Skip to main content
. 2020 Aug 5;25(3):230–237. doi: 10.1111/jns.12402

TABLE 2.

List of CIDP studies with an improvement primary endpoint or studies with a stability vs deterioration primary endpoint 4 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 17 , 18 , 20 , 21 , 23

Study Active treatment Primary endpoint measure Sample size Dose Duration of study/phase Placebo arm response Active arm response
Total Placebo Active
CIDP studies with an improvement endpoint
Hughes et al 14 (ICE phase 1) Gamunex (IVIG) Total adjusted INCAT 117 58 59 1 g/kg every 3 weeks 24 weeks 21% improved 54% improved
Mendell et al 17 Gammar IV (IVIG) AMS 53 23 30 1 g/kg every 3 weeks 6 weeks 9% improved 38% improved
Hadden et al 10 Interferon beta 1a Improvement in any 3 of 8 clinical measures a 10 Crossover study 3 MIU 3x per week 2 weeks and 6 MIU for 10 weeks 12 weeks 20% improved 10% improved
Hahn et al 12 IVIG NDS, CG, and grip strength 30 Crossover study 0.4 g/kg bw over 5 days 9 weeks 17% improved 63% improved

Hahn et al 11

Plasma exchange NDS, CG, andgrip strength 18 Crossover study 10 exchanges over 4 weeks 9 weeks 0% improved 80% improved
Vermeulen et al 21 IVIG Rankin scale and MRC sum score 28 13 15 0.4 g/kg bw over 5 days 3 weeks 23% improved 27% improved
van Doorn et al 20 IVIG Rankin scale 7 Crossover study 0.4 g/kg bw over 5 days Unclear 0% improved 100% improved
Dyck et al 8 Plasma exchange NDS 29 14 15 Twice a week 3 weeks 0% improved 33% improved
Dyck et al 9 Plasma exchange NDS 14 7 7 Twice a week 3 weeks 43% improved 57% improved
CIDP studies with a stability vs deterioration endpoint
Hughes et al 13 (FORCIDP) Fingolimod Total adjusted INCAT 106 52 54 0.5 mg daily 3 years 43% non‐deterioration 42% non‐deterioration
van Schaik et al 4 (PATH) Hizentra (SCIG) Total adjusted INCAT 172 51 b 115 c 0.2 or 0.4 g/kg weekly 24 weeks 37% non‐deterioration 61%‐67% non‐deterioration
Markvardsen et al 16 Subcuvia (SCIG) IKS 30 15 14 1:1 previous IVIG dose 12 weeks 33% non‐deterioration 79% non‐deterioration

RMC et al 18

(RMC group)

Methotrexate Reduction in mean weekly dose d 59 32 27 7.5‐15 mg weekly 32 weeks 44% maintained 52% maintained

Hughes et al 14

(ICE phase 2)

Gamunex (IVIG) Total adjusted INCAT 57 26 31 1 g/kg every 3 weeks 24 weeks 58% non‐deterioration 87% non‐deterioration

Abbreviations: AMS, average muscle score; CG, functional clinical grade; IKS, isokinetic strength; INCAT, inflammatory neuropathy cause and treatment; IVIG, intravenous immunoglobulin; MRC, Medical Research Council; NDS, neurological disability scale; SCIG, subcutaneous immunoglobulin.

a

Clinical measures included: timed 10‐m walk, ambulation index, expanded Medical Research Council (MRC) sum score, nine‐hole peg test time, functional independence measure, Hammersmith motor ability, a new Guy's neurological disability scale, and the EuroQoL quality of life scale.

b

20% reduction in mean weekly dose of IVIG or corticosteroids in last 4 weeks compared with first 4 weeks.

c

Of the 172 subjects randomized in the original paper, six from the placebo group were removed from our analysis due to either withdrawing without relapse (n = 4) or erroneously entering the restabilization phase (n = 2). This results in n = 51 for the placebo arm.

d

Combined SCIG‐treatment groups (0.2 g/kg, n = 57 and 0.4 g/kg, n = 58).