Impact of Warm Compresses on Local Injection-Site Reactions with Self-Administered Glatiramer Acetate

Jolly, Helen; Simpson, Kellie; Bishop, Barbara; Hunter, Heli; Newell, Cassie; Denney, Douglas R.; Oleen-Burkey, MerriKay

doi:10.1097/01376517-200808000-00007

Cited by 18 publications

(13 citation statements)

References 14 publications

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“…Attempts have been made already to prevent local skin reactions via oral antihistamines and warm compresses. 129,130 In conclusion, this systematic review shows that DMTs in MS are frequently associated with local injection-site reactions and a wide range of other cutaneous adverse events.…”

Section: Discussionmentioning

confidence: 99%

Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review

et al. 2012

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Glatiramer acetate and interferon-beta are approved first-line disease-modifying treatments (DMTs) for multiple sclerosis (MS). DMTs can be associated with cutaneous adverse events, which may influence treatment adherence and patient quality of life. In this systematic review, we aimed to provide an overview of the clinical spectrum and the incidence of skin reactions associated with DMTs. A systematic literature search was performed up to May 2011 in Medline, Embase, and Cochrane databases without applying restrictions in study design, language, or publishing date. Eligible for inclusion were articles describing any skin reaction related to DMTs in MS patients. Selection of articles and data extraction were performed by two authors independently. One hundred and six articles were included, of which 41 (39%) were randomized controlled trials or cohort studies reporting incidences of mainly local injection-site reactions. A large number of patients had experienced some form of localized injection-site reaction: up to 90% for those using subcutaneous formulations and up to 33% for those using an intramuscular formulation. Sixty-five case-reports involving 106 MS patients described a wide spectrum of cutaneous adverse events, the most frequently reported being lipoatrophy, cutaneous necrosis and ulcers, and various immune-mediated inflammatory skin diseases. DMTs for MS are frequently associated with local injection-site reactions and a wide spectrum of generalized cutaneous adverse events, in particular, the subcutaneous formulations. Although some of the skin reactions may be severe and persistent, most of them are mild and do not require cessation of DMT.

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Section: Discussionmentioning

confidence: 99%

Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review

et al. 2012

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“…TOXICOLOGIC PATHOLOGY (Soares Almeida et al 2006). Incidence of these effects is reduced by rotation of the injection sites or by applying warm compresses before injection (Jolly et al 2008). Rarely, panniculitis, mostly lobular, followed by lipoatrophy, appears in the area of injection (Drago et al 1999;Edgar et al 2004;Hwang and Orengo 2001;Mancardi et al 2000;Soares Almeida et al 2006;Soos et al 2004).…”

Section: Discussionmentioning

confidence: 99%

Comparative Long-Term Preclinical Safety Evaluation of Two Glatiramoid Compounds (Glatiramer Acetate, Copaxone®, and TV-5010, Protiramer) in Rats and Monkeys

et al. 2011

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Glatiramer acetate (GA), the active ingredient in Copaxone 1 , is a complex mixture of polypeptides used for the treatment of relapsing remitting multiple sclerosis. Glatiramoids are related mixtures that may differ in some characteristics of the prototype molecule. Our aim is to describe the long-term toxicity studies with protiramer (TV-5010), a new glatiramoid, in comparison with similar studies conducted with GA. The toxicity of twice-weekly subcutaneous injections of protiramer to Sprague-Dawley rats (twenty-six weeks) and cynomolgus monkeys (fifty-two weeks) was compared with similar studies done with daily subcutaneous injections of GA. Daily treatment with GA was safe and well tolerated, without systemic effects or death. Protiramer administration was not as well tolerated as GA and led to dose-and time-related mortalities, probably mediated through severe injection-site lesions both in rats and in monkeys. Bridging fibrosis in the liver and severe progressive nephropathy were seen in rats. A dose-related increase in eosinophils was observed in monkeys. The protiramer toxicity studies show that minor variations in the manufacturing of glatiramoids may lead to significant toxic effects. It is therefore essential that the safety of any new glatiramoid be studied in long-term preclinical studies before exposing humans.

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“…3 Other proposed methods include topical hydrocortisone, topical lidocaine/prilocaine cream, oral antihistamine, use of skin cooling with ice, heating with warm compresses, and topical herbal products. [4][5][6][7] Synera topical adhesive (S-TA; Galen US Inc., Souderton, PA) is a peel-and-stick patch containing an anesthetic mixture of lidocaine 70 mg and tetracaine 70 mg. It also has a patented heat-assisted drug delivery system.…”

Section: Resultsmentioning

confidence: 99%

“…It is possible that the heating itself plays a role in reducing pain, although heat application with a warm compress before injection did not reduce pain in another study. 7 The effect of lowering the FOI may also have contributed to the pain reductions, which could be further assessed through a placebocontrolled trial.…”

Section: Discussionmentioning

confidence: 99%

“…Secondary outcomes included 12-and 24-hour pain ratings (0-10 VAS), LISR scale scores 24 hours after injection (0-6, see the study by Jolly et al 7 ), fear of injection (FOI) immediately before injection (0-10 VAS, 0 = no fear and 10 = extreme fear), tenderness at 24 hours (0-10 VAS, 0 = no tenderness and 10 = extreme tenderness), Subject Global Impression (SGI; level of comfort with injections during the past week, 1-7 VAS, 1 = terrible and 7 = delighted), participant rating of 60-versus 30-minute application times, and participant rating of interest in using the patch. Except for participant rating of 60-versus 30-minute application times, all testing was performed at baseline and at the end of 60-and 30-minute study periods.…”

mentioning

confidence: 99%

See 1 more Smart Citation

A Topical Adhesive Containing Anesthetic and Heating Components to Reduce Injection Pain with Subcutaneous Multiple Sclerosis Medications

Brown¹,

Simnad²

2017

International Journal of MS Care

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Impact of Warm Compresses on Local Injection-Site Reactions with Self-Administered Glatiramer Acetate

Cited by 18 publications

References 14 publications

Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review

Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review

Comparative Long-Term Preclinical Safety Evaluation of Two Glatiramoid Compounds (Glatiramer Acetate, Copaxone®, and TV-5010, Protiramer) in Rats and Monkeys

A Topical Adhesive Containing Anesthetic and Heating Components to Reduce Injection Pain with Subcutaneous Multiple Sclerosis Medications

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