What are the available evidence and guidelines for immune globulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)?

Comment by InpharmD Researcher

The evidence and guidelines recommend intravenous immunoglobulin (IVIg) as the initial treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). Induction treatment typically involves a total IVIg dose of 2 g/kg over 2 to 5 days. Maintenance therapy can be administered through either IVIg or subcutaneous immunoglobulin (SCIg), with no preference for either route. Commonly reported IVIg maintenance doses are 1 g/kg every three weeks. Individualized dosing based on disease severity and progression is advised. Limited comparative data exist for corticosteroids or plasma exchange, necessitating further research on long-term benefits and cost-effectiveness. SCIg may offer similar efficacy with a preferable safety profile in terms of systemic adverse events.

Background

Per the 2021 updated European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), use of intravenous immunoglobulin (IVIg) is strongly recommended as initial treatment in typical CIDP and CIDP variants and should be considered as first-line treatment in motor CIDP (Good Practice Point). The usual total IVIg dose of 2 g/kg, divided over 2 to 5 days, is generally used for induction treatment, and two to five repeated doses of 1 g/kg IVIg every 3 weeks may be needed based on clinical responses to the initial treatment regimen. In the presence of end-of-dose deterioration before the next IVIg infusion, dose may need to be increased, or infusion interval may be shortened. [1]

For maintenance therapy, either IVIg or subcutaneous immunoglobulin (SCIg) are recommended, with no preference for one route over the other. While the most optimal dosing regimen for IVIg maintenance is not well-established, a dose of 1 g/kg every 3 weeks has been most commonly reported in clinical trials. Regardless, clinical practice should consider lower doses and longer treatment intervals maintaining maximal sustained improvement (e.g., 0.4-1 g/kg every 2-6 weeks). When switching patients from IVIg to SCIg, clinicians may start with the same mean dose (1:1) per week and adjust doses based on reliable outcome measures. Compared to IVIg, subcutaneous administration renders additional benefits of self-treatment at home, avoidance of intravenous cannulation, and possibly fewer systemic side effects; however, SCIg (subcutaneous swelling and pain) may lead to more local side effects and more frequent infusions, especially when a high-dose (>20-30 g/infusion) is required. [1]

A 2021 review discusses various treatment options for CIDP, including use of IVIg. Due to historical use and clinical data, including a Cochrane meta-analysis, the authors consider IVIg as a first-line treatment unless there is a contraindication. However, there is no agreement upon dosing or frequency for all CIDP patients, and the dose should be individualized per patient. Patients with severe and rapid conditions should receive more aggressive and higher doses compared to milder, slowly progressive cases. A common dosing schedule is every 3 to 4 weeks, but the amount needed may vary. Patients will require periodic monitoring by a neuromuscular physician to assist in individualized treatment. Based on early data, the authors typically initiated with a loading dose of 2 g/kg over 5 days, then 0.4 g/kg per week in severe cases. Milder cases may be exempt from the loading dose and only require 0.4 g/kg every other week. Adverse events from clinical studies suggest a risk of headaches, dermatological eruptions, and serious thromboembolic events. Therefore, use is cautioned in patients with cardiovascular conditions or history like recent thromboembolic events. Patients may receive pretreatment with antihistamines, corticosteroids, or NSAIDs to reduce risk of allergic reactions or headache. Periodic renal function monitoring may be considered for patients at risk (i.e., older age, diabetes, prior history of renal injury). When possible, low-osmolality formulations should be used as sucrose can worsen renal injury, and glucose can lead to hyperglycemia. [2]

A 2017 Cochrane overview summarized the evidence from Cochrane and non-Cochrane systematic reviews of any treatment for CIDP, including IVIg, and provided comparisons among different interventions. Compared to placebo, a 2013 Cochrane meta-analysis found more participants had improved after IVIg (78 out of 141; 53%) than after placebo (30 out of 28; 23%) based on 5 randomized trials involving 235 participants (risk ratio [RR] 2.40, 95% confidence interval [CI] 1.72 to 3.36), corresponding to a number needed to treat for an additional beneficial outcome of 3.03 (95% CI 2.33 to 4.55; high-quality evidence). Only one 2008 trial (N= 117) reported long-term disability outcome based on Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at 24 weeks, observing mean improvement from baseline disability of 1.1 ± 1.8 and 0.3 ± 1.3 with IVIg and placebo, respectively (mean difference 0.8, 95% CI 0.23 to 1.37). Additionally, use of IVIg was associated with a higher risk of adverse events, such as headache, nausea, chills, and fever compared to placebo (49% vs. 18%; RR 2.62, 95% CI 1.81 to 3.78). No significant difference was noted in the incidence of serious adverse events. [3], [4]

Comparative data to corticosteroids or plasma exchange appeared to be less robust. Results from individual trials generally reported no significant differences between IVIg and oral prednisolone, IV methylprednisolone, prednisone, or plasma exchange in short-term improvement of impairment or disability, while one 2012 study reported less treatment discontinuation in IVIg group than intravenous methylprednisolone group (13% vs. 52%; RR 0.54, 95% CI 0.34 to 0.87). However, corticosteroids are generally more widely available, cheaper, and easier to use than IVIg. Future trials are needed to investigate the long-term benefits and cost-effectiveness of IVIg and other interventions. [3]

A 2017 meta-analysis compared the efficacy and safety of IV versus subcutaneous (SC) immune globulin for management of inflammatory demyelinating polyneuropathies. Patients with CIDP and/or multifocal motor neuropathy (MMN) were included with muscle strength assessed using the Medical Research Council sum score (MRC-SS). The effect size (ES) was used to measure the raw mean difference between the two formulations. A total of 8 studies (N= 138) were included in the meta-analysis, which found no significant difference in muscle strength outcome in patients with CIDP (ES 0.84; 95% CI -0.01 to 1.69). However, SCIg reported a 28% reduction in relative risk for moderate and/or systemic adverse events compared to IVIg (95% CI 0.11 to 0.76). Based on these findings, efficacy appears to be similar with SCIg conferring a greater safety profile. However, other measurements of muscle strength were excluded from the analysis, and the range of examined muscles varied between studies. Follow-up varied between 3.5 to 24 months, and the majority of patients were switched from IVIg to SCIg. [5]

References:

[1] Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision [published correction appears in J Peripher Nerv Syst. 2022 Mar;27(1):94] [published correction appears in Eur J Neurol. 2022 Apr;29(4):1288]. J Peripher Nerv Syst. 2021;26(3):242-268. doi:10.1111/jns.12455
[2] Stino AM, Naddaf E, Dyck PJ, Dyck PJB. Chronic inflammatory demyelinating polyradiculoneuropathy-Diagnostic pitfalls and treatment approach. Muscle Nerve. 2021;63(2):157-169. doi:10.1002/mus.27046
[3] Oaklander AL, Lunn MP, Hughes RA, van Schaik IN, Frost C, Chalk CH. Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. Cochrane Database Syst Rev. 2017;1(1):CD010369. Published 2017 Jan 13. doi:10.1002/14651858.CD010369.pub2
[4] Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013;(12):CD001797. Published 2013 Dec 30. doi:10.1002/14651858.CD001797.pub3
[5] Racosta JM, Sposato LA, Kimpinski K. Subcutaneous versus intravenous immunoglobulin for chronic autoimmune neuropathies: A meta-analysis. Muscle Nerve. 2017;55(6):802-809. doi:10.1002/mus.25409

Literature Review

A search of the published medical literature revealed 4 studies investigating the researchable question:

What are the available evidence and guidelines for immune globulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Tables 1-4 for your response.


 

Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy

Design

Prospective, double-blind, randomized, parallel-group, multicenter, phase III study

N= 142

Objective

To investigate the efficacy and safety of 10% liquid intravenous immunoglobulin (Panzyga®) in patients with active chronic inflammatory demyelinating polyneuropathy (CIDP) at three different doses

Study Groups

0.5 g/kg (n= 34)

1.0 g/kg (n= 69)

2.0 g/kg (n= 36)

Inclusion Criteria

Aged 18 years or older, diagnosed with definite or probably CIDP, dependent on treatment with immunoglobulins or corticosteroids

Exclusion Criteria

Previous failure of immunoglobulin treatment, treated with other immunomodulatory agents 6 months prior, treated with immuno-chemotherapeutic regimens, evidence of peripheral neuropathy from another cause

Methods

Patients underwent an initial screening phase and washout period prior to randomization. During the washout period, the patient's current medications were reduced to a predefined standard manner to ensure they had active CIDP. After a max 12 weeks of washout, patients were then randomized (1:2:1) to receive either 0.5, 1.0, or 2.0 g/kg IVIg. All patients received an initial induction dose of 2.0 g/kg IVIg prior to randomization, where seven maintenance doses were administered.

Duration

24 weeks of treatment in the dose-evaluation phase

Outcome Measures

Primary: rate of responders in the 1.0 g/kg group defined as improvement in 1 point or greater in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score at week 6 versus baseline

Secondary: comparison of response rate of the 0.5 g/kg and 2.0 g/kg group versus 1.0 g/kg group, including grip strength, Inflammatory Rasch-built Overall Disability Scale (I-RODS) score, and Medical Research Council (MRC) score

Baseline Characteristics

 

0.5 g/kg (n= 34)

1.0 g/kg (n= 69)

2.0 g/kg (n= 36)  

Age, years

57 59 61  

Female

38% 45% 36%  

Body mass index, kg/m2

27 27 25  

Definite CIPD

Probable CIPD

34

0

68

1

36

0

 

Type of CIPD

Typical

Atypical

 

33

1

 

62

7

 

32

4

 

Prior treatment

Corticosteroids

Immunoglobulins

 

29

5

 

60

9

 

32

4

 

Adjusted INCAT score (range 0-10)

4

4

4

 

Results

Endpoint

0.5 g/kg (n= 34)

1.0 g/kg (n= 69)

2.0 g/kg (n= 36)

p-value

Responders at week 24 based on adjusted INCAT score (95% confidence interval [CI])

65 (48-79)

80 (69-88)

92 (78-97)

0.040

 

0.5 vs. 1.0 g/kg

2.0 vs. 0.5 g/kg

2.0 vs. 1.0 g/kg

 

Odds ratio (95% CI)

Adjusted INCAT score

Grip strength

I-RODS

MRC sum score

 

0.5 (0.2 to 1.2)

0.6 (0.3 to 1.4)

0.5 (0.2 to 1.3)

0.6 (0.2 to 1.4)

 

5.8 (1.4 to 23.6)

4.2 (1.4 to 13.3)

3.9 (1.4 to 10.8)

4.1 (1.2 to 13.2)

 

2.7 (0.7 to 10.2)

2.5 (0.9 to 7.0)

2.1 (0.8 to 5.0)

2.3 (0.8 to 6.7)

 

Adverse Events

The distribution of treatment-related adverse events was 45.7% in the 0.5 g/kg group, 46.4% in the 1.0 g/kg group, and 52.6% in the 2.0 g/kg group. The most common adverse events were headache, allergic dermatitis, pyrexia, chills, blood pressure increase, body temperature increase, and nausea, among the three groups.

Six patients reported serious adverse events, with one discontinuing treatment due to headache and nausea. Two adverse events led to patient death, but neither was deemed related to the study drug.

Study Author Conclusions

Intravenous immunoglobulin (1.0 g/kg) was efficacious and well tolerated as maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy. Further studies of different maintenance doses of intravenous immunoglobulin in chronic inflammatory demyelinating polyneuropathy are warranted.

InpharmD Researcher Critique

Only patients with established CIDP were included, rather than newly diagnosed or untreated patients. The 24-week study period limits the interpretation of use for long-term or life-long treatment. Notably, no statistical power was performed to detect a dose-response effect between the three regimens.



References:

Cornblath DR, van Doorn PA, Hartung HP, et al. Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy. Brain. 2022;145(3):887-896. doi:10.1093/brain/awab422

 

Randomized trial of intravenous immunoglobulin maintenance treatment regimens in chronic inflammatory demyelinating polyradiculoneuropathy

Design

Randomized, placebo-controlled, crossover trial

N= 25

Objective

To investigate whether high frequent low dosage intravenous immunoglobulin (IVIg) treatment is more effective and results in fewer side effects than low frequent high dosage IVIg treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Study Groups

Group A (normal dose and interval 1st; n= 13)

Group B (half dose and interval 1st; n= 12)

Inclusion Criteria

Aged 18 years or older fulfilling the European Federation of Neurological Societies/Peripheral Nerve Society diagnostic criteria for CIDP and who were receiving a stable dose and interval of 10% liquid IVIg maintenance treatment

Exclusion Criteria

Known IgA deficiency or known allergic reaction to IVIg; hand grip strength ≥ the median value (kPa) for age and sex-matched healthy control; maintenance dose <15 g of IVIg every infusion or an infusion interval <14 days; known hereditary neuropathy or severe concomitant diseases; multifocal motor neuropathy; IgM paraprotein with antimyelin-associated glycoprotein
(MAG) antibodies; atypical CIDP (pure sensory, persistent unifocal, central nervous system involvement) 

Methods

The trial consisted of one baseline infusion, four blinded infusions, two wash-out infusions, and thereafter another four blind infusions. At baseline, all patients received treatment based on their own individually adjusted dose and interval of IVIg. During the double-blinded phases, patients were randomized to receive either half of their normal individual dose at half of their normal interval first (intervention), or their normal dose and interval first, with intermittent placebo infusions (albumin 0.5%) to maintain the blinding (control). After receiving wash-out infusions, patients then switched to the opposite treatment regimens. 

Concomitant immunosuppressive drugs were only allowed if the dose remained unchanged in the 8 weeks before the start of the trial and the daily dose of prednisone did not exceed 20 g. Before each IVIg infusion, the nurse who administered the treatment assessed the handgrip strength (mean of the three measurements of both hands was used) of each patient. 

Duration

Enrollment: Between 2015 and 2018 

Outcome Measures

Primary: score on the Martin Vigorimeter (handgrip strength)

Secondary: clinical (disability, fatigue, and quality of life), Inflammatory Rasch-built Overall Disability Scale (I-RODS), modified Rasch-built Fatigue Severity Scale (R-FSS), 36-item Short-Form Health Survey (SF-36), serum IgG levels, serious adverse events (SAEs) and side effects

Baseline Characteristics

  All participants (n= 22*)

 

 

Age, years

67    

Male

73%    

Body weight, kg 

81    

Duration of IVIg treatment, years (range)

4 (0 to 31)    

IVIg dosage per infusion, g

43 ± 17    

IVIg dosage per kg bodyweight, g

0.55 ± 0.24    

IVIg dose per week, g (range)

14 (5 to 40)    

IVIg interval, days (range)

14 (14 to 35)     

Vigorimeter value, kPa

63 ± 46    

Serum IgG, g/L

Trough 

Peak

 

16 ± 4

28 ± 7

   

*Three patients who showed an exacerbation of CIDP during the second blinded phase were excluded from the analysis. 

Results

Endpoint

All participants (n= 22*)

Difference (95% confidence interval [CI]) p-value 

Mean handgrip strength 

After intervention treatment 

After control regimen

 

61 ± 22

64 ± 21

-2.9 (−4.9 to −0.78) 0.009
 

Coefficient (effect of the intervention on outcome)

95% CI  p-value 

Vigorimeter score, kPa

-2.71 -5.4 to 0.01 0.07

R-FSS

-0.01 -0.2 to 0.2 0.90

I-RODS

-0.02 -0.4 to 0.4 0.93

Serum IgG trough, g/L

0.67 0.3 to 1.1 0.002

There was no significant difference in Vigorimeter score change from baseline between the treatment regimens. Furthermore, there were no significant differences between the treatment regimens in the secondary outcome indicators. 

Overall, the IgG trough level was slightly higher in the normal dose and interval regimen. 

Adverse Events

Common Adverse Events: normal dose and interval vs. half dose and interval: fatigue (86% vs. 91%), muscle and joint ache (77% vs. 73%), headache (50% vs. 59%), warm feeling (59% vs. 50%), backache (55% vs. 46%), shortness of breath (50% vs. 41%)

Serious Adverse Events: None 

Percentage that Discontinued due to Adverse Events: N/A

Study Author Conclusions

More frequent lower dosing does not further improve the efficacy of IVIg in stable IVIg-dependent CIDP and does not result in fewer side effects.

InpharmD Researcher Critique

The generalizability of study findings is limited by a small sample size of patients included and strict inclusion and exclusion criteria. The comparisons between two maintenance schedules may not readily apply to other adjusted dosing regimens. 



References:

Kuitwaard K, Brusse E, Jacobs BC, et al. Randomized trial of intravenous immunoglobulin maintenance treatment regimens in chronic inflammatory demyelinating polyradiculoneuropathy. Eur J Neurol. 2021;28(1):286-296. doi:10.1111/ene.14501

 

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Design

Randomized, double-blind, placebo-controlled phase 3 trial

N= 172

Objective

To investigate the comparison of two doses of subcutaneous immune globulin (SCIg; Hizentra®) versus placebo for maintenance treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIPD)

Study Groups

Placebo (n= 57)

Low-dose SCIg (n= 57)

High-dose SCIg (n= 58)

Inclusion Criteria

Aged 18 years or older, diagnosed with definite or probably CIPD, received their last IVIg treatment at least within 8 weeks of enrolment

Exclusion Criteria

Any polyneuropathy of other causes, any other diseases with neurological symptoms or could interfere without treatment outcome/assessments, pregnancy/lactation

Methods

All patients initially underwent an IgG dependency test period (up to 12 weeks) and an IVIg restabilization period (up to 13 weeks) to ensure patients still needed IgG before randomization. Then, patients were randomized (1:1:1) to receive 0.2 g/kg (low-dose) or 0.4 g/kg (high-dose) of a 20% SCIg solution (IgPro20) weekly versus placebo (2% human albumin solution).

Duration

24 weeks of treatment

Outcome Measures

Primary: CIPD relapse (deterioration of INCAT score by 1 or more points) or withdrawn for any other reason during the treatment period, absolute risk reduction (ARR) for reaching the primary endpoint

Baseline Characteristics

 

Placebo (n= 57)

Low-dose SCIg (n= 57)

High-dose SCIg (n= 58)  

Age, years

57.6 58.9 55.2  

Body mass index, kg/m2

28.4 26.4 26.6  

Duration of disease, years

2.7 2.8 3.3  

Definite CIPD

Probably CIPD

93%

7%

89%

11%

91%

9%

 

INCAT disability score (range 0-10)

2.0 2.0 2.0  

Results

Endpoint

Placebo (n= 57)

Low-dose SCIg (n= 57)

High-dose SCIg (n= 58)

p-value

CIPD relapse

36 (63%)

22 (39%)

19 (33%)

0.0007

ARR for the primary endpoint (95% confidence interval [CI]) versus placebo

p-value

--

--

25% (6-41)

0.007

30% (12-46)

0.001

--

--

ARR for the primary endpoint (95% CI) versus high-dose SCIg

--

6% (-11 to 23)

--

0.32

Adverse Events

Adverse events occurred in 27% in the placebo group, 30% in the low-dose group, and 34% in the high-dose group. Rates of serious events did not significantly differ. One episode of acute allergic skin reaction was deemed causally related to the study drug. 

Study Author Conclusions

This study, which is to our knowledge, the largest trial of CIDP to date and the first to study two administrations of immunoglobulins and two doses, showed that both doses of SCIg IgPro20 were efficacious and well tolerated, suggesting that SCIg can be used as a maintenance treatment for CIDP.

InpharmD Researcher Critique

The study focused only on subcutaneous immune globulin. The authors noted that the inclusion of an IVIg group was not feasible due to the calculated power requiring many patients.



References:

van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet Neurol. 2018 Jan;17 (1):26] [published correction appears in Lancet Neurol. 2018 Aug;17(8):661]. Lancet Neurol. 2018;17(1):35-46. doi:10.1016/S1474-4422(17)30378-2

 

Subcutaneous immunoglobulin as first-line therapy in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy: randomized controlled trial study

Design

Randomized, single-blind, cross-over study

N= 20

Objective

To investigate whether multiple subcutaneous infusions are as effective as conventional therapy with intravenous loading doses in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy (CIDP)

Study Groups

Subcutaneous immunoglobulin [SCIG] then Intravenous immunoglobulin [IVIG] (n= 10)

IVIG then SCIG (n= 10)

Inclusion Criteria

Patients diagnosed with definite or pure motor CIDP, naive to immune modulatory therapy and fulfilling the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society

Exclusion Criteria

Age <18 or >80 years, other causes of neuropathy, known malignant disease, treatment with other immune-modulating therapy, or documented IgA deficiency

Methods

Eligible patients were randomized to receive either SCIG 0.4 g/kg/week for 5 weeks, applying two to three infusions per week, or IVIG 0.4 g/kg/day for 5 days. After 10 weeks, patients were switched to the opposite treatment arm and followed for a further 10 weeks. For all infusions, a portable mechanical pump with a 60-mL syringe was used. The SCIG was administered at home by the patient after careful supervision by the study nurse at the hospital, whereas IVIG was infused during hospitalization.

Duration

Follow-up: 20 weeks

Outcome Measures

Primary: combined isokinetic muscle strength (cIKS)

Secondary: disability, clinical evaluation of muscle strength, and various function tests

Baseline Characteristics

 

IVIG then SCIG (n= 10)

SCIG then IVIG (n= 10)

 

Mean age, years

52.3 ± 12.8  56.7 ± 8.1  

Female, n

1  

Mean weight, kg

92.6 ± 23.8 83.2 ± 17.9  

Duration of CIDP, months

23 ± 20.7 8.5 ± 7.3  

Neuropathy Impairment Score

45.8 ± 18.4   45.4 ± 21.1  

Mean relative combined isokinetic muscle strength, %

68.2 ± 23.0 64.1 ± 21.6   

Mean cerebrospinal fluid protein, g/L

0.68 ± 0.33  0.91 ± 0.56  

Baseline function tests

Medical Research Council (MRC) score

Grip strength, kg

Nine-hole peg test (9-HPT), s

40-m walk test (40-MWT), s

Overall disability sum score (ODSS)

Plasma immunoglobulin G (IgG)

 

83.9 ± 5.1

27.0 ± 15.9

30.2 ± 19.6 

24.0 ± 5.6

3.5 ± 1.6

11.8 ± 2.5

 

84.0 ± 5.3

25.6 ± 13.3

36.4 ± 45.6

24.6 ± 7.3

3.5 ± 1.4

11.9 ± 2.6 

 

Results

Endpoint

SCIG (n= 10)

IVIG (n= 10)

p-value

Improvement in cIKS 

Overall average

2 weeks

5 weeks

10 weeks

 

7.4 ± 14.5%

3.7 ± 10.4%

11.2 ± 17.1%

7.5 ± 14.5%

 

6.9 ± 16.8%

10.2 ± 17.0%

7.5 ± 18.3%

1.3 ± 13.2%

 

<0.05*

ND

ND

ND

cIKS improvement during treatment periods

Treatment period 1 (first 10 weeks)

Treatment period 2 (second 10 weeks)

 

11 ± 22.7% (at week 5)

6.6 ± 13.0% (at week 5)

 

12 ± 22.8% (at week 5)

3.4 ± 34.6% (at week 2)

 

0.96 

0.79

Function tests at week 10

Medical Research Council (MRC) score

Grip strength, kg

Nine-hole peg test (9-HPT), s

40-m walk test (40-MWT), s

Overall disability sum score (ODSS)

Plasma immunoglobulin G (IgG)

 

85.0 ± 5.1

28.2 ± 13.7

28.2 ± 21.0

22.8 ± 7.5

2.9 ± 1.7

13.5 ± 2.7

 

84.5 ± 5.6

27.7 ± 16.0

32.1 ± 35.0 

23.4 ± 8.2

3.3 ± 1.7

12.2§ ± 2.8

 

--

--

--

--

--

<0.05

*p-value compared to baseline (0.0003 for SCIG and 0.002 for IVIG)

p< 0.05 vs. week 0 for SCIG

§p< 0.05 vs. week 0 for IVIG

ND, no difference

Significant difference in cIKS from baseline was observed only at week 5 week for SCIG and week 2 for IVIG. No difference in cIKS was found between SCIG and IVIG therapy at 2, 5 or 10 weeks.

The overall disability sum score improved during SCIG treatment (p= 0.002) after 5 and 10 weeks (p< 0.05), whereas there was no significant improvement after IVIG.

During treatment period 1, after 2 weeks of therapy, cIKS had improved following IVIG therapy, whereas SCIG values had not yet improved compared with baseline. 

Adverse Events

IVIG: hemolytic anemia (n= 2), fever/chill and nausea (n= 2), mild dermatological reaction (n= 2), and headache (n= 6). Side effects were mostly mild. One patient experienced spontaneous and remitting severe hemolytic anemia following IVIG therapy with a decrease in hemoglobin of 42 g/L leading to hospitalization. 

SCIG: local skin reactions (3) and nausea (n= 2)

Study Author Conclusions

In conclusion, this study demonstrates that, despite different bioavailability, SCIG and IVIG given at the same dose have similar effects on muscle strength in treatment-naive patients with CIDP. The authors suggest that SCIG can be used as first-line treatment in patients with newly diagnosed CIDP. If the response to SCIG is weak or absent, a shift to other well-documented treatments, such as IVIG, steroids, or plasma exchange, should be considered.

InpharmD Researcher Critique

The study is limited by its crossover design and small sample size. Some comparisons between patients receiving SICG and patients receiving IVIG were not performed at the same time points.  



References:

Markvardsen LH, Sindrup SH, Christiansen I, et al. Subcutaneous immunoglobulin as first-line therapy in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy: randomized controlled trial study. Eur J Neurol. 2017;24(2):412-418. doi:10.1111/ene.13218