Matches in SemOpenAlex for { <https://semopenalex.org/work/W2767805413> ?p ?o ?g. }
- W2767805413 endingPage "46" @default.
- W2767805413 startingPage "35" @default.
- W2767805413 abstract "Background Approximately two-thirds of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) need long-term intravenous immunoglobulin. Subcutaneous immunoglobulin (SCIg) is an alternative option for immunoglobulin delivery, but has not previously been investigated in a large trial of CIDP. The PATH study compared relapse rates in patients given SCIg versus placebo. Methods Between March 12, 2012, and Sept 20, 2016, we studied patients from 69 neuromuscular centres in North America, Europe, Israel, Australia, and Japan. Adults with definite or probable CIDP who responded to intravenous immunoglobulin treatment were eligible. We randomly allocated participants to 0·2 g/kg or 0·4 g/kg of a 20% SCIg solution (IgPro20) weekly versus placebo (2% human albumin solution) for maintenance treatment for 24 weeks. We did randomisation in a 1:1:1 ratio with an interactive voice and web response system with a block size of six, stratified by region (Japan or non-Japan). The primary outcome was the proportion of patients with a CIDP relapse or who were withdrawn for any other reason during 24 weeks of treatment. Patients, caregivers, and study personnel, including those assessing outcomes, were masked to treatment assignment. Analyses were done in the intention-to-treat and per-protocol sets. This trial is registered with ClinicalTrials.gov, number NCT01545076. Findings In this randomised, double-blind, placebo-controlled trial, we randomly allocated 172 patients: 57 (33%) to the placebo group, 57 (33%) to the low-dose group, and 58 (34%) to the high-dose group. In the intention-to-treat set, 36 (63% [95% CI 50–74]) patients on placebo, 22 (39% [27–52]) on low-dose SCIg, and 19 (33% [22–46]) on high-dose SCIg had a relapse or were withdrawn from the study for other reasons (p=0·0007). Absolute risk reductions were 25% (95% CI 6–41) for low-dose versus placebo (p=0·007), 30% (12–46) for high-dose versus placebo (p=0·001), and 6% (−11 to 23) for high-dose versus low-dose (p=0·32). Causally related adverse events occurred in 47 (27%) patients (ten [18%] in the placebo group, 17 [30%] in the low-dose group, and 20 [34%] in the high-dose group). Six (3%) patients had 11 serious adverse events: one (2%) patient in the placebo group, three (5%) in the low-dose group, and two (3%) in the high-dose group; only one (an acute allergic skin reaction in the low-dose group) was assessed to be causally related. Interpretation 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. Funding CSL Behring." @default.
- W2767805413 created "2017-11-17" @default.
- W2767805413 creator A5000099912 @default.
- W2767805413 creator A5000121504 @default.
- W2767805413 creator A5000937852 @default.
- W2767805413 creator A5001010955 @default.
- W2767805413 creator A5001310894 @default.
- W2767805413 creator A5002658085 @default.
- W2767805413 creator A5004846083 @default.
- W2767805413 creator A5006001878 @default.
- W2767805413 creator A5006382220 @default.
- W2767805413 creator A5006934160 @default.
- W2767805413 creator A5007821161 @default.
- W2767805413 creator A5008196074 @default.
- W2767805413 creator A5009245206 @default.
- W2767805413 creator A5009588500 @default.
- W2767805413 creator A5010916362 @default.
- W2767805413 creator A5011011071 @default.
- W2767805413 creator A5011059482 @default.
- W2767805413 creator A5011121650 @default.
- W2767805413 creator A5011460522 @default.
- W2767805413 creator A5012480460 @default.
- W2767805413 creator A5012993440 @default.
- W2767805413 creator A5013023361 @default.
- W2767805413 creator A5013885401 @default.
- W2767805413 creator A5013956389 @default.
- W2767805413 creator A5014510701 @default.
- W2767805413 creator A5015323665 @default.
- W2767805413 creator A5016038658 @default.
- W2767805413 creator A5016147756 @default.
- W2767805413 creator A5016651740 @default.
- W2767805413 creator A5017783761 @default.
- W2767805413 creator A5018139999 @default.
- W2767805413 creator A5018482136 @default.
- W2767805413 creator A5018559634 @default.
- W2767805413 creator A5019347256 @default.
- W2767805413 creator A5019352922 @default.
- W2767805413 creator A5020075606 @default.
- W2767805413 creator A5020120126 @default.
- W2767805413 creator A5020224380 @default.
- W2767805413 creator A5020335454 @default.
- W2767805413 creator A5020666895 @default.
- W2767805413 creator A5022594173 @default.
- W2767805413 creator A5022814721 @default.
- W2767805413 creator A5024161429 @default.
- W2767805413 creator A5025033398 @default.
- W2767805413 creator A5029419212 @default.
- W2767805413 creator A5029479247 @default.
- W2767805413 creator A5029492419 @default.
- W2767805413 creator A5030217409 @default.
- W2767805413 creator A5030805385 @default.
- W2767805413 creator A5031447559 @default.
- W2767805413 creator A5031675925 @default.
- W2767805413 creator A5032751597 @default.
- W2767805413 creator A5032855935 @default.
- W2767805413 creator A5033797544 @default.
- W2767805413 creator A5035489373 @default.
- W2767805413 creator A5035702105 @default.
- W2767805413 creator A5035898886 @default.
- W2767805413 creator A5037350756 @default.
- W2767805413 creator A5037584672 @default.
- W2767805413 creator A5038628313 @default.
- W2767805413 creator A5038633707 @default.
- W2767805413 creator A5038642272 @default.
- W2767805413 creator A5038943351 @default.
- W2767805413 creator A5039905544 @default.
- W2767805413 creator A5041920520 @default.
- W2767805413 creator A5041994767 @default.
- W2767805413 creator A5043038167 @default.
- W2767805413 creator A5043184590 @default.
- W2767805413 creator A5043834214 @default.
- W2767805413 creator A5044149528 @default.
- W2767805413 creator A5045210357 @default.
- W2767805413 creator A5045535997 @default.
- W2767805413 creator A5045704441 @default.
- W2767805413 creator A5046217001 @default.
- W2767805413 creator A5046451291 @default.
- W2767805413 creator A5047268222 @default.
- W2767805413 creator A5047850510 @default.
- W2767805413 creator A5048443947 @default.
- W2767805413 creator A5048588036 @default.
- W2767805413 creator A5049181172 @default.
- W2767805413 creator A5049829315 @default.
- W2767805413 creator A5050308657 @default.
- W2767805413 creator A5050847001 @default.
- W2767805413 creator A5051045476 @default.
- W2767805413 creator A5052549369 @default.
- W2767805413 creator A5052630833 @default.
- W2767805413 creator A5053206032 @default.
- W2767805413 creator A5055164764 @default.
- W2767805413 creator A5055705453 @default.
- W2767805413 creator A5056639160 @default.
- W2767805413 creator A5057765317 @default.
- W2767805413 creator A5058790967 @default.
- W2767805413 creator A5059243583 @default.
- W2767805413 creator A5060055087 @default.
- W2767805413 creator A5061195481 @default.
- W2767805413 creator A5061347020 @default.