Management of type 1 hypersensitivity reactions to antituberculosis drug: Succesful Desensitization

doi:10.21203/rs.3.rs-1752643/v1

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Management of type 1 hypersensitivity reactions to antituberculosis drug: Succesful Desensitization

https://doi.org/10.21203/rs.3.rs-1752643/v1

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Objective: Type 1 hypersensitivity reaction includes reactions such as dry itching, rash, urticaria, angioedema, and anaphylaxis that usually occur within the first hour after taking the drug. In this study, it was aimed to investigate the prevalence of type 1 hypersensitivity reaction under treatment and treatment management in tuberculosis patients.

Methods: The study is a case series; All of the patients who were hospitalized between 01.02.2015- 01.05.2021 were examined. All patients who developed a drug-induced type 1 hypersensitivity reaction were included. Antituberculosis drugs were given with the protocol made by Buhari et al. However, unlike what is stated in the protocol, pyrazinamide was given last during the administration of the drugs.

Results:

2677 patients received inpatient tuberculosis treatment; type 1 hypersensitivity reactions were seen in 94 (3.5%) patients. Due to missing data in the file, 81 patients were included in the study. 44 (54.3%) of the cases were women; mean age (mean ± SD) 50.7 ± 17.69 years; 76 (93.8%) of them are citizens of the Republic of Turkey; 58 (71.6%) of them were diagnosed bacteriologically; 65 (80.2%) of them were pulmonary tuberculosis. The most common skin finding was urticaria in 49 (60.5%). The drug responsible for the most common reaction was pyrazinamide. In 49 (60.5%) cases, drugs were given by desensitization and it was successful. The duration of treatment was 7.91 ± 2.5 months (6-18 months). When evaluated in terms of treatment results, 68 (84%) patients successfully completed the treatment.

Conclusion: Our study is the largest series of patients in which the demographic and clinical characteristics of type 1 IgE-mediated hypersensitivity developed under antituberculosis treatment were examined. An applicable, understandable and successful diagnostic process roadmap and desensitization scheme that can be used in this situation are presented.

Tuberculosis is the leading cause of death from infectious disease in adults worldwide. In drug-sensitive patients, treatment is started with isoniazid, rifampicin, ethambutol and pyrazinamide. (1,2) Drug hypersensitivity in tuberculosis is an important problem affecting the treatment process. All of the antituberculosis drugs could potentially be responsible. Although treatment is initiated with isoniazid, rifampicin, ethambutol and pyrazinamide, drug changes may be required due to hypersensitivity. The presence of isoniazid and rifampicin in the regimen provides the advantage of shorter treatment time. (3) Management of hypersensitivity is very important due to long treatment time and increased side effects with secondary drugs. (4) Successful desensitization in hypersensitivity is very important in terms of patient compliance, treatment success and treatment cost. There are different desensitization protocols applied for early-type IgE-mediated reactions in tuberculosis. (5,6,7,8) We shared the characteristics of our patients who developed IgE-mediated hypersensitivity while receiving tuberculosis treatment, our treatment management and the success of the desensitization scheme we applied.

The design of the study is a case series. Patients aged 18 years and older who were hospitalized in the hospital registry system between 01.02.2015 and 01.05.2021 and were consulted to the Allergy and Immunology Clinic due to type 1 drug hypersensitivity were included. Patients who did not receive desensitization in accordance with the scheme we recommend, and patients with non-tuberculosis mycobacterial infections were not included.

The primary aim of the study is to determine the appropriate treatment scheme in type 1 hypersensitivity reaction; The secondary aim is to determine the treatment management of type 1 hypersensitivity reaction.

Demographic data of the patients, diagnosis of tuberculosis, clinical features of type 1 hypersensitivity reaction and time of occurrence, drug treatments, and treatment results were evaluated.Age, gender and nationality were noted in demographic data. According to the World Health Organization(WHO), countries are in 6 different regions; Africa, America, Eastern Mediterranean, Europe, Asia and Western Pacific are examined.(9) Cases were also analyzed according to WHO country grouping.

Tuberculosis diagnoses, organ involvement and treatments were evaluated as determined in the Turkish Ministry of Health Tuberculosis Diagnosis and Treatment Guide published in 2019. (2) Diagnoses were classified as smear positive, culture positive, molecular test positive, histopathological diagnosis, clinical radiological diagnosis; organ involvement pulmonary and extrapulmonary; the extrapulmonary group is grouped as miliary, lymph node, pleura, kidney, pericardium, larynx.

When the type 1, early type drug hypersensitivity reaction is mentioned, sudden redness, itching, urticaria, angioedema, rhinitis, conjunctivitis, bronchospasm, anaphylaxis, which develops in the first hour after taking the drug but can last up to six hours, are evaluated. Desensitization is the ability of an individual to use the drug to which they are sensitive. (10, 11) After treatment of type 1 hypersensitivity in patients who developed a reaction, drug desensitization was performed in accordance with the specified scheme. The development time of the existing reaction, the success of the applied desensitization, and the duration of treatment were evaluated.

The way of desensitization is given by the protocol made by Buhari et al. (7) However, unlike what is stated in the protocol, pyrazinamide was given last during the administration of the drugs. If prick and intradermal test were applied as diagnostic test for the responsible drug, it was noted. Isoniazid, ethambutol and pyrazinamide tablet; An intradermal test was performed with rifampicin ampoule. Intradermal testing with rifampicin was performed at a concentration of 0.002 mg/mL. (12) Each drug was given in at least 6 steps; 2.5 times between doses and drug administration times not exceeding 30 minutes. (10, 11) The drugs were given under the supervision of a physician and nurse. A drug was given every day; If hypersensitivity did not develop, the next day after the full dose of the drug was given, the new drug was added by desensitization. When hypersensitivity developed, desensitization was performed after being treated according to international guidelines. After the regimen was completed, the patient was given a full dose of all drugs for several days; He was discharged after it was seen that he could take it without any problems.

Desensitization Scheme Applied in Patients with Type1 Hypersensitivity Reaction:

DAY 1

08:00: Isoniazid

Solution A: 1 tablet of 300 mg of isoniazid is diluted with 40 cc of 0.9% NaCl.

The resulting concentration is 7.5 mg/mL.

08:00 1 cc solution A----------7.5 mg

08:30 2 cc solution A ---------15 mg

09:00 3 cc solution A----------22.5 mg

09:30 1/8 tablet of isoniazid------37.5 mg

10:00 ¼ tablet of isoniazid -------75 mg

11:00 ½ tablet of isoniazid--------150 mg

DAY 2

08:00:

300 mg of isoniazid

09.00: For rifampicin

Solution B: 2 capsules of 600 mg of rifampicin are diluted with 60 cc of 0.9% NaCl. The resulting concentration is 10 mg/ml.

08:00 1 cc solution B----------10 mg

08:30 2 cc B solution ----------20 mg

09:00 5 cc B solution -----------50 mg

09:30 10 cc B solution ---------100 mg

10:00 20 cc B solution ---------200 mg

11:00 22 cc B solution --------220 mg

DAY 3:

08:00:

isoniazid 300 mg +

rifampicin 600mg

09.00: For ethambutol

Solution C: 1 tablet of 500 mg ethambutol is diluted with 10 cc of 0.9% NaCl. The resulting concentration is 50 mg/ml.

Solution D: It is taken from 2 cc of C solution. It is diluted with 18 cc 0.9% NaCl. The resulting concentration is 5 mg/ml.

08:00 1 cc D solution---------------5 mg

08:30 2cc solution D---------------10 mg

09:00 4cc D solution---------------20 mg

09:30 8 cc D solution---------------40 mg

10:00 2 cc solution C---------------100 mg

10:30 4 cc solution C---------------200 mg

11:00 One tablet ethambutol-----------500 mg

12:00 1 + ¼ tablet ethambutol--------625 mg

DAY 4

08:00:

isoniazid 300 mg +

rifampicin 600mg +

ethambutol 1500 mg

09.00: For pyrazinamide

Solution E: 1 tablet of 500 mg pyrazinamide is diluted with 10 cc of 0.9% NaCl. The resulting concentration is 50 mg/ml.

F solution: It is taken from 3 cc E solution. It is diluted with 27 cc 0.9% NaCl. The resulting concentration is 5 mg/ml.

08:00 2 cc solution F---------------10 mg

08:30 4 cc F solution---------------20 mg

09:00 8 cc F solution---------------40 mg

09:30 16 cc solution F---------------80 mg

10:00 3 cc E solution---------------150 mg

10:30 4 cc solution C---------------200 mg

11:00 One tablet of pyrazinamide -----------500 mg

12:00 2 tablets of pyrazinamide --------1000 mg

DAY 5 : HRZE

DAY 6: HRZE

DAY 7: HRZE

In the statistics of the study; All analyzes were performed using SPSS 22.0. Differences in the mean were evaluated with the Mann-Whitney U test. Relative risk, odd ratios, and 95% confidence intervals were calculated. Chi-square and logistic regression analysis were used for categorical parameters.

Ethics committee approval of the University of Health Sciences, Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital was obtained for this study. (dated 03.06.2021, protocol code: 116.2017.R-225)

The study population consisted of 81 patients who developed hypersensitivity between 01.02.2015 and 01.05.2021. 42 (51.8%) of the cases were women. Mean age (mean ± SD) 50.7 ± 17.69 years; 76 (93.8%) of them are citizens of the Republic of Turkey; all of Asian descent; 58 (71.6%) of them were diagnosed bacteriologically; 65 (80.2%) of them were pulmonary tuberculosis; 4 (4.9%) of them had previously received antituberculosis treatment. (Table 1)

Table 1

Demographic and clinical characteristics of the patients
VARIABLE				N (%)
GENDER		FEMALE		42 (%51.8)
GENDER		MAN		39 (%48.2)
AGE		(MEAN ± SD)		50.7 ± 17.69
NATIONALITY		TURKEY		76 (%93.8)
			UZBEKİSTAN	1 (%1.2)
			TURKMENISTAN	1 (%1.2)
			KYRGIZSTAN	1 (%1.1)
			SYRIA	2 (%2.5)
			GEORGIA	1 (%1.2)
WHO COUNTRY CLASSIFICATION			ASIA	81 (%100)
DIAGNOSIS			SPUTUM POSITIVE	39 (%48.1)
			CULTURE POSITIVE	19 (%23.5)
			MOLECULAR TEST POSITIVE	2 (%2.5)
			HISTOPATHOLOGICAL	17 (%21)
			CLINICAL- RADIOLOGICAL	4 (%4.9)
ORGAN APPLICATION	PULMONARY			65 (%80.2)
	EXTRAPULMONARY		LYMPH NODE	7 (%8.6)
			PLEURA	8 (%9.9)
			KIDNEY	1 (%1.2)
PRIOR TREATMENT	NO			77 (%95.1)
PRIOR TREATMENT	YES			4 (%4.9)

Table 2

Clinical features of type 1 hypersensitivity under treatment
Table 2	FEMALE N (%)	MALE N (%)	TOTAL N (%)
PRURITIS	9 (%10.2)	12 (%15.7)	21 (%25.9)
URTICARIA	30 (%35.8)	19 (%24.7)	49 (%60.5)
ANGIOEDEMA	3 (%3.7)	4 (%4.8)	7 (%8.5)
URTICARIA + ANGIOEDEMA	2 (%2.5)	2 (%2.5)	4 (%5)

The most common skin finding was urticaria in 49 (60.5%) cases.Pruritis was observed in 21 (25.9%) cases, angioedema in 7 (8.5%) cases, and urticaria and angioedema in 4 (5%) cases. Anaphylaxis was not observed in any case. (Table 2) The development time (mean ± SD) of the reaction in patients who developed a reaction was 5.28 ± 15.24 days.

In the event of a reaction, discontinuation of the current treatment regimen was considered sufficient in 26 (32.1%) cases; In 36 (44.4%) cases, treatment was discontinued and antihistamine was administered; Antihistamine and oral/parenteral steroids were given together in 19 (23.5%) subjects. Anaphylaxis requiring adrenaline and oxygen support was not observed in any patient.

Table 3

Drugs responsible for hypersensitivity
RESPONSIBLE DRUG	FEMALE	MALE	TOTAL
ISONIAZIDE	6	1	7
RIFAMPICINE	8	--	8
ETAMBUTOL	2	1	4
PYAZINAMIDE	10	7	17
STREPTOMYCIN	--	--	--
PAS	--	1	1
PROTIONAMİDE	--	1	1
LINEZOLIDE	1	--	1
TOTAL	27	11	38

Of the 81 patients who developed a hypersensitivity reaction, 38 responsible drugs could be identified. The drug responsible for the most common reaction was pyrazinamide in 17 cases. Subsequently, rifampicin, isoniazid and ethambutol were found to be responsible. Among all patients, more than one drug was determined as the responsible agent in 7 (8.6%) cases. (Table 3)

Diagnostic test in patients who develop type 1 hypersensitivity reaction is skin prick test with drugs used in treatment and early reading of intradermal test. Skin prick test was performed in 9 cases. Among these cases, the isoniazid prick test was positive in one case. Intradermal tests with rifampicin ampoule at a concentration of 1/30,000 (0.002 mg/ml) were negative. Isoniazid, rifampicin, ethambutol and pyrazinamide treatment were given with successful desensitization in the patient with a positive prick test. The treatment processes of the patients who underwent diagnostic tests are as indicated in the table below. (Table 4)

Table 4

Characteristics of patients undergoing diagnostic tests
Case	Skin Finding	First Treatment	Prick Test Positive	Rıfampıcıne IDT Positive	Long time treatment	Hypersensitivity Responsible Drug
1	Angioedema	HRZE	No	No	HRZE	Could not be determined.
2	Urtıcarıa				Isonıazıde Rıfampıcıne Etambutol Levofloxacin	Pirazinamid
3	Urtıcarıa				HRZE	Could not be determined.
4	Urtıcarıa				Rıfampıcıne Streptomycın Pyazınamıde Moxifloxacın Cyloserıne	Isonıazıde Etambutol
5	Urtıcarıa		Isonıazıde		HRZE	Rıfampıcıne
6	Angioedema		No		HRZE	Isonıazıde
7	Angioedema				HRZE	Could not be determined.
8	Urtıcarıa				HRZE
9	Angioedema				HRZE

Among all patients, in 49 (60.5%) cases, the sensitive regimen and drugs were administered with desensitization in accordance with the scheme, and it was successful. Although there was drug sensitivity, 7 cases were switched to an alternative scheme due to hepatotoxicity. Responsible agents were determined as PAS and protinamide in one case among those who developed hepatotoxicity. However, because desensitization was not successful, it was excluded from the treatment. (Table 5) Although desensitization was started with the sensitive regimen in 25 patients, the regimen was changed when hypersensitivity developed.

Table 5

Characteristics of patients who developed hepatotoxicity
Case	Age Gender	Reaction Day	Skin Sign	First Treatment	Hypersensıtıvıty Developing Treatment	Desensitization Applied Regime	Responsible Agent
1	40,F	0	Pruritis	HRZE	Isonıazıde Etambutol Moxifloxacın Cyloserıne AmIkasIn	Isonıazıde Etambutol Moxifloxacın Cyloserıne AmIkasIn
2	73,M	1	Urtıcarıa		Etambutol Moxifloxacın Cyloserıne Streptomycın	Etambutol Moxifloxacın Cyloserıne Streptomycın
3	18, M	1	Pruritis		Isonıazıde Rıfampıcıne Etambutol Moxifloxacın	Isonıazıde Rıfampıcıne Etambutol Moxifloxacın
4	41, F	0	Pruritis		Isonıazıde Etambutol Pyazınamıde Moxifloxacın Cyloserıne	Isonıazıde Etambutol Pyazınamıde Moxifloxacın Cyloserıne
5	63, M	2	Pruritis		Isonıazıde Etambutol Pyazınamıde Cyloserıne Protionamid PAS	Isonıazıde Etambutol Moxifloxacın Linezolid	PAS Protionamid
6	37, M	1	Pruritis		Isonıazıde Rıfampıcıne Etambutol Moxifloxacın	Isonıazıde Rıfampıcıne Etambutol Moxifloxacın
7	56, M	1	Pruritis		Isonıazıde Rıfampıcıne Moxifloxacın	Isonıazıde Rıfampıcıne Moxifloxacın

The duration of treatment was 7.91 ± 2.5 months (6–18 months). When evaluated in terms of treatment results, 68 (84%) patients successfully completed the treatment; 1 (1.2%) patient was excluded from follow-up; 3 (3.7%) patients died during the treatment process, and 9 (11.1%) patients are still under treatment.

This study consists of the largest series of patients with drug-sensitive tuberculosis who developed type 1 IgE-mediated drug hypersensitivity while receiving treatment.

In addition to studies reporting that type 1, IgE-mediated hypersensitivity due to antituberculosis treatment is associated with female gender (4, 13, 14); There are also studies stating that hypersensitivity reactions are not affected by gender. (15) In our study, there was no difference between male and female genders.

The most common skin finding was urticaria; In the literature, the most common skin finding in type 1 IgE-mediated hypersensitivity is stated as urticaria. (16, 17)

Our hospital is one of the major centers for tuberculosis in Turkey and is located in Turkey's largest metropolis, such as Istanbul. All of our patients are citizens of the Republic of Turkey; He was of Asian descent by nationality. Looking at the literature, female gender, Asian origin, advanced age and HIV infection are associated with adverse reactions in antituberculosis treatment. (18) We think that this predisposition in those of Asian descent may be related to genetic predisposition, HLA.

In the patient who develops hypersensitivity, all drugs are stopped and the current situation is treated, and then giving the drugs one by one by desensitization is the approach we recommend. The most common agent found to be responsible for hypersensitivity was pyrazinamide in our study. In this case, we think that the last addition to desensitization would be more appropriate.

Considering 9 patients who underwent diagnostic testing, the prick test was positive in isoniazid in one patient. This patient was able to tolerate isoniazid with desensitization without any problems. In the same patient, urticaria developed when rifampicin was first added to the treatment with desensitization, but all drugs could be started again with desensitization for the second time. In yet another patient, the prick test and intradermal test performed with drugs were found to be negative; When drugs were started with desensitization, urticaria developed with isoniazid in the first desensitization, and urticaria with ethambutol developed in the second desensitization, and isoniazid-ethambutol was removed from the regimen and an alternative regimen was started. In this case, it is seen that there is a need for validation in diagnostic tests performed with antituberculosis drugs. Data on basophil activation test used in Type1 IgE-mediated reactions are limited. Despite limited data with lymphocyte transformation test, it can talk about low sensitivity and high specificity. (19) However, the use of these tests is also limited due to their cost.

The gold standard for finding the drug responsible for drug hypersensitivity is drug provocation. Even if diagnostic skin tests cannot be performed, when the drugs are re-administered, finding the responsible agent and removing it from the treatment is compatible with better treatment results. (20) Restarting the treatment with desensitization, not removing strong drugs such as isoniazid and rifampicin from the regimen provides a shorter treatment time and treatment success (1, 2) The duration of treatment with secondary antituberculosis drugs without first generation agents can be up to a minimum of 18 months. (21) It is a more effective method to give the primary drugs by desensitization instead of immediately replacing them with secondary drugs. (22) We also recommend that primary antituberculosis drugs be administered by desensitization and, if unsuccessful, regimen changes are made.

In tuberculosis, while it is necessary to stop the drugs due to the developing hypersensitivity reaction, it is necessary to start the maintenance treatment quickly due to the risk of drug resistance and reactivation. (23) Bermingham et al. suggested that in type 1 IgE-mediated reactions, while the drugs will be restarted, several different pathways can be followed. One of them is that all drugs can be given with rapid drug desensitization and this decision should be made for the patient. (24) We also recommend performing diagnostic tests, if possible, and administering all drugs by desensitization, leaving the positive agent for the last. If a diagnostic test cannot be performed, we think that it is appropriate to administer the drugs isoniazid, rifampicin, ethambutol and pyrazinamide, respectively. Because adverse drug reactions related to antituberculosis treatment can cause treatment failure, morbidity and mortality. This situation leads to increased economic results with more frequent hospital admissions, hospitalizations and more examinations. (25) We believe that the right management will bring success.

When we look at the treatment results, 84% of the patients successfully completed the treatment after desensitization. No treatment failure was observed. Although there are different schemes recommended for desensitization (26, 27, 28, 29), we can say that our scheme is usable when we look at our treatment results.

In conclusion, our study is the largest series of patients in which the demographic and clinical characteristics of type 1 IgE-mediated hypersensitivity developed under antituberculosis treatment were examined. An applicable, understandable and successful diagnostic process roadmap and desensitization scheme that can be used in this situation are presented.

WHO

World Health Organization

HRZE

Isonıazıde + Rıfampıcıne + Etambutol + Pirazinamid

PAS

Paraamino salicylic acid

Written informed consent to participate and publish was obtained from all individual participants included in the study.

The authors have no conflicts of interest to declare.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data available on request from the authors.

All authors take part of Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Validation; Visualization; Writing-original draft.

I would like to express my special thanks of gratitude to my daugther, Defne; my family and all authors studying with me. I am really thankful to them.

This study was ethically approved by the ethics committee of the University of Health Sciences, Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital (dated 03.06.2021, protocol code: 116.2017.R-225)

Zeynep Yegin Katran, [email protected], ORCID: 0000-0002-6858-6824

İsmet Bulut , [email protected], Orcıd: 0000-0002-8111-6149

Aylin Babalık, [email protected], Orcıd: 0000-0002-4872-1558

Metin Keren, [email protected], Orcıd: 0000-0003-1047-6149

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Management of type 1 hypersensitivity reactions to antituberculosis drug: Succesful Desensitization

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