Reactivity of IgE and IgG serum levels to chymopapain after chemonucleolysis

Sagona, Michael A.; Bruszer, George V.; Nelson, John; Mascoli, Carmine C.; Serkes, Kenneth D.

doi:10.1016/0091-6749(85)90090-9

Cited by 11 publications

(4 citation statements)

References 11 publications

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“…25 Because condoliase is also a foreign protein, 29 the risk of anaphylaxis cannot be excluded. Because chymopapain is derived from papain, which is widely used as a meat tenderizer, 16,24 sensitization may be more common for chymopapain, while the possibility of similar sensitization to condoliase may be low. However, further information needs to be collected from more patients to fully evaluate its safety.…”

Section: Discussionmentioning

confidence: 99%

A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation

Matsuyama

Chiba

Iwata

et al. 2018

Journal of Neurosurgery: Spine

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OBJECTIVEChemonucleolysis with condoliase has the potential to be a new, less invasive therapeutic option for patients with lumbar disc herniation (LDH). The aim of the present study was to determine the most suitable therapeutic dose of condoliase.METHODSPatients between 20 and 70 years of age with unilateral leg pain, positive findings on the straight leg raise test, and LDH were recruited. All eligible patients were randomly assigned to receive condoliase (1.25, 2.5, or 5 U) or placebo. The primary end point was a change in the worst leg pain from preadministration (baseline) to week 13. The secondary end points were changes from baseline in the following items: worst back pain, Oswestry Disability Index (ODI), SF-36, and neurological examination. For pharmacokinetic and pharmacodynamic analyses, plasma condoliase concentrations and serum keratan sulfate concentrations were measured. The safety end points were adverse events (AEs) and radiographic and MRI parameters. Data on leg pain, back pain, abnormal neurological findings, and imaging parameters were collected until week 52.RESULTSA total of 194 patients received an injection of condoliase or placebo. The mean change in worst leg pain from baseline to week 13 was −31.7 mm (placebo), −46.7 mm (1.25 U), −41.1 mm (2.5 U), and −47.6 mm (5 U). The differences were significant at week 13 in the 1.25-U group (−14.9 mm; 95% CI −28.4 to −1.4 mm; p = 0.03) and 5-U group (−15.9 mm; 95% CI −29.0 to −2.7 mm; p = 0.01) compared with the placebo group. The dose-response improvement in the worst leg pain at week 13 was not significant (p = 0.14). The decrease in the worst leg pain in all 3 condoliase groups was observed from week 1 through week 52. Regarding the other end points, the worst back pain and results of the straight leg raise test, ODI, and SF-36 showed a tendency for sustained improvement in each of the condoliase groups until week 52. In all patients at all time points, plasma condoliase concentrations were below the detectable limit (< 100 μU/ml). Serum keratan sulfate concentrations significantly increased from baseline to 6 hours and 6 weeks after administration in all 3 condoliase groups. No patient died or developed anaphylaxis or neurological sequelae. Five serious AEs occurred in 5 patients (3 patients in the condoliase groups and 2 patients in the placebo group), resolved, and were considered unrelated to the investigational drug. Severe AEs occurred in 10 patients in the condoliase groups and resolved or improved. In the condoliase groups, back pain was the most frequent AE. Modic type 1 change and decrease in disc height were frequent imaging findings. Dose-response relationships were observed for the incidence of adverse drug reactions and decrease in disc height.CONCLUSIONSCondoliase significantly improved clinical symptoms in patients with LDH and was well tolerated. While all 3 doses had similar efficacy, the incidence of adverse drug reactions and decrease in disc height were dose dependent, thereby suggesting that 1.25 U would be the recommended clinical dose of condoliase.Clinical trial registration no.: NCT00634946 (clinicaltrials.gov)

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Section: Discussionmentioning

confidence: 99%

A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation

Matsuyama

Chiba

Iwata

et al. 2018

Journal of Neurosurgery: Spine

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“…Some PLCPs may induce clinical reactions only in the presence of high levels of exposure to them, as occurs in some geographical areas [ 23 ] or in occupational diseases [ 70 ] or taking drugs with a high concentration of chymopapain [ 71 ] or bromelain [ 72 ]. In all other cases, it seems that some food PLCPs may induce the production of specific IgE in the absence of symptoms.…”

Section: Plcp Allergenicitymentioning

confidence: 99%

“…Chymopapain-based drugs, administered by intradiscal injection, were used in the past for the treatment of patients with herniated intervertebral discs (chemonucleolysis). However, this treatment is no longer used, as nearly 1% of the treated patients experienced anaphylaxis [ 71 , 119 , 121 ].…”

Section: Sources Of Plcps Known For Allergenicity And/or Ige Bindingmentioning

confidence: 99%

“…Conversely, these two arthropod allergens, to which the exposure route is generally inhalation [69], provided an important contribution to the prevalence of symptoms common to mite allergy, such as rhinitis, bronchial asthma and conjunctivitis. Some PLCPs may induce clinical reactions only in the presence of high levels of exposure to them, as occurs in some geographical areas [23] or in occupational diseases [70] or taking drugs with a high concentration of chymopapain [71] or bromelain [72]. In all other cases, it seems that some food PLCPs may induce the production of specific IgE in the absence of symptoms.…”

Section: Plcp Allergenicitymentioning

confidence: 99%

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Plant and Arthropod IgE-Binding Papain-like Cysteine Proteases: Multiple Contributions to Allergenicity

Giangrieco,

Ciardiello,

Tamburrini

et al. 2024

Foods

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Papain-like cysteine proteases are widespread and can be detected in all domains of life. They share structural and enzymatic properties with the group’s namesake member, papain. They show a broad range of protein substrates and are involved in several biological processes. These proteases are widely exploited for food, pharmaceutical, chemical and cosmetic biotechnological applications. However, some of them are known to cause allergic reactions. In this context, the objective of this review is to report an overview of some general properties of papain-like cysteine proteases and to highlight their contributions to allergy reactions observed in humans. For instance, the literature shows that their proteolytic activity can cause an increase in tissue permeability, which favours the crossing of allergens through the skin, intestinal and respiratory barriers. The observation that allergy to PLCPs is mostly detected for inhaled proteins is in line with the reports describing mite homologs, such as Der p 1 and Der f 1, as major allergens showing a frequent correlation between sensitisation and clinical allergic reactions. In contrast, the plant food homologs are often digested in the gastrointestinal tract. Therefore, they only rarely can cause allergic reactions in humans. Accordingly, they are reported mainly as a cause of occupational diseases.

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Chymopapain induced allergic reactions

Bernstein

1986

Clin Rev Allergy

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Reactivity of IgE and IgG serum levels to chymopapain after chemonucleolysis

Cited by 11 publications

References 11 publications

A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation

A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation

Plant and Arthropod IgE-Binding Papain-like Cysteine Proteases: Multiple Contributions to Allergenicity

Chymopapain induced allergic reactions

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