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Observational Study
. 2021 Apr 6;96(14):e1876-e1886.
doi: 10.1212/WNL.0000000000011703. Epub 2021 Feb 16.

Quantifying Treatment-Related Fluctuations in CIDP: Results of the GRIPPER Study

Jeffrey A Allen  1 , Mamatha Pasnoor  2 , Mazen M Dimachkie  2 , Senda Ajroud-Driss  2 , Thomas H Brannagan  2 , Albert A Cook  2 , Timothy Walton  2 , Mark B Fiecas  2 , John T Kissel  2 , Ingemar Merkies  2 , Kenneth C Gorson  2 , Richard A Lewis  2
Affiliations
Observational Study

Quantifying Treatment-Related Fluctuations in CIDP: Results of the GRIPPER Study

Jeffrey A Allen et al. Neurology. .

Abstract

Objective: The objective of this study was to explore the extent of IV immunoglobulin (IVIG) treatment-related fluctuations (TRFs) by using home collection of daily grip strength in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and to use that information to develop evidence-based treatment optimization strategies.

Methods: This prospective observational study included 25 patients with well-defined CIDP. Participants recorded grip strength daily for 6 months. Disability and gait metrics were collected weekly. Serum immunoglobulin G levels were obtained at peak, trough, and midcycle IVIG intervals. Day-to-day grip strength changes <10% were considered random. To identify patients with TRFs, 3-day averaged grip strength was calculated on each consecutive day after an IVIG infusion. TRFs were defined as ≥10% 3-day averaged grip strength difference compared to the pre-IVIG baseline.

Results: Participants successfully recorded grip strength on all but 9% of recordable days. Twelve patients (48%) were classified as low/no fluctuaters and 13 (52%) as frequent fluctuaters. In the frequent fluctuating group, grip strength improved over 1 week and thereafter was relatively stable until the third week after infusion. Grip strength was significantly correlated with measures of disability.

Conclusions: Grip strength collection by patients at home is reliable, valid, and feasible. A change in grip strength by ≥10% is a useful, practical, and evidence-based approach that may be used to identify clinically meaningful TRFs. From these data, we propose a treatment optimization strategy for patients with CIDP on chronic IVIG that may be applied to routine clinic care during both face-to-face and virtual video or telephone patient encounters.

Trial registration information: ClinicalTrials.gov Identifier: NCT02414490.

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Figures

Figure 1
Figure 1. Correlation Between Grip Strength Collected by Patients and Nurses in Dominant and Nondominant Hands
Figure 2
Figure 2. Dominant and Nondominant Hand TRFs in 25 Patients
Treatment-related fluctuation (TRF) deterioration (white), TRF improvement (black), or no TRFs (gray) in patients receiving IV immunoglobulin (IVIG). D = dominant hand; N = nondominant hand. *Patients classified as frequent fluctuaters.
Figure 3
Figure 3. Percent Change in 3-Day Averaged Dominant and Nondominant (Combined) Hand Grip Strength
Grip strength across all patients and all cycles in participants with (A) frequent treatment-related fluctuations (TRFs) and (B) low or no TRFs.
Figure 4
Figure 4. Proposed Approach to IVIG Optimization for Patients With CIDP on Long-Term IVIG Therapy
CIDP = chronic inflammatory demyelinating polyradiculoneuropathy; GS = grip strength; IVIG = IV immunoglobulin; TRF = treatment-related fluctuation.
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