The majority of patients do not store their biologic disease-modifying antirheumatic drugs within the recommended temperature range

Vlieland, Nicolaas D.; Gardarsdóttir, Helga; Bouvy, Marcel L.; Egberts, Toine C. G.; Bemt, Bart J F van den

doi:10.1093/rheumatology/kev394

Cited by 48 publications

(52 citation statements)

References 24 publications

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“…Although liquid formulations of therapeutic proteins are typically intended to remain in liquid form at controlled temperature, accidental freezing can occur, especially during shipping in containers cooled with gel packs, 38 or in formulations intended for home administration. 45 In the polyclonal antibody formulations tested here, increased levels of particles were seen when IVIg formulations in prefilled syringes were subjected to agitation, or when formulations were freeze-thawed in vials. The present study was designed to probe whether subvisible particles in protein formulations are capable of complement activation, and so we used a variety of formulations and accelerated stress conditions to create samples with a range of particle sizes and concentrations, but we did not attempt to elucidate the detailed mechanisms by which each stress fostered particle formation.…”

Section: Discussionmentioning

confidence: 87%

Subvisible Particles in IVIg Formulations Activate Complement in Human Serum

Chisholm

Behnke

Pokhilchuk

et al. 2020

Journal of Pharmaceutical Sciences

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When administered intravenously, various particles and nanomedicines activate complement, potentially leading to infusion reactions and other adverse drug reactions. Particles form within formulations of therapeutic proteins due to stresses incurred during shipping, handling, and administration to patients. In this study, IVIg solutions were stored in multiple types of vials and prefilled syringes and exposed to agitation and freeze-thaw stresses to generate particles. The stressed samples were added to human serum to determine whether these particles activated complement. Subvisible IVIg particles ranging in size between 2 and 10 microns activated complement in a fashion that was linearly dependent on the number of particles dosed, whereas little correlation was found between doses of larger particles (>10 microns) and complement activation. Activation of complement by subvisible particles of IVIg followed the alternative pathway, as shown by the release of complement cascade factor Bb and the production of the anaphylatoxins C3a and C5a without generation of C4a. The number and the morphology of subvisible particles formed depended on the applied stress, formulation, and on the container material. But the capacity of the 2-to 10-micron-sized particles to activate complement in human serum appeared to depend only on particle concentration.

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Section: Discussionmentioning

confidence: 87%

Subvisible Particles in IVIg Formulations Activate Complement in Human Serum

Chisholm

Behnke

Pokhilchuk

et al. 2020

Journal of Pharmaceutical Sciences

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“…Improper storage for more than two consecutive hours has been reported in 24.3% of patients using biologics. Improper storage at low temperature (<0°) is more common than that at high temperature (>25°C) (Vlieland, Gardarsdottir, Bouvy, Egberts, & van den Bemt, ). Patients should consult with the manufacturer prior to administration of improperly stored medications.…”

Section: Types Of Negative Injection Experiencesmentioning

confidence: 99%

Classification and mitigation of negative injection experiences with biologic medications

Fernandez

Madsen

Krase

et al. 2020

Dermatologic Therapy

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Injection site reactions with biologic medications are encountered with variable frequency. Although there is no clear definition, they commonly manifest with pain and irritation at the injection site. Previously proposed reaction classification systems may be impractical or insufficient, and more intuitive nomenclature may benefit clinical dermatologists and patients. Negative injection experiences (NIE) are common reasons for biologic medication nonadherence. Here we provide clinical classifications and recommendations for mitigating these reactions. We categorized NIEs into the following: (a) physical, due to the needle and injection process, (b) irritant, related to properties of the injected solution, and (c) allergic, both immediate and delayed.

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“…Nejadnik et al 115 then wrote a commentary summarizing the "state of the art" and actions to be taken. Vlieland et al 116 monitored storage temperatures for biological drug products at patient's homes and reported major deviations from the prescribed temperature range. Both freezing-thawing excursions and excursions to ambient temperature for prolonged periods were observed.…”

Section: Handling Of Biologics In Real-life Situationsmentioning

confidence: 99%