Convex light appliance and mouldable rings for ostomy patients: who benefits most?

Abstract

Aim The aim of this study was to evaluate the effectiveness of a combined treatment strategy involving the use of a light convex ostomy appliance (Easiflex Confort Convex Light) and a flexible ring (Brava moldable) in reducing the number of leak episodes and improving self-reported satisfaction in patients with digestive ostomies and early effluent leakage.

Methods A multicenter prospective study was conducted across 54 stoma units in Spain, with 257 patients screened and 244 completing the study. Clinical data were collected at baseline (V1) and 2–3 weeks after discharge (V2) by specialist stoma care nurses. The primary outcome was a reduction in the mean number of leak episodes per day. The secondary outcome was a change in self-reported satisfaction on a scale of 0–10. A multivariate analysis was conducted to identify the patient profile that benefited the most from the treatment strategy.

Results The results showed a significant reduction in the mean number of leak episodes from 3.4±5.2 at baseline to 1.3±2.3 at the end of the study (P<0.0001). Additionally, the mean self-reported satisfaction with the device increased from 5.1±2 at baseline to 7.2±1.7 at the end of the study (P<.00001). A predictive model with an area under the curve of 0.74 was developed to identify the patient profile that benefited the most from the treatment strategy.

Conclusions The study confirmed that patients with ostomy and early effluent leakage benefit from convex light ostomy appliances and flexible rings. To improve satisfaction, those with worse outcomes and higher needs should be treated early with the CONAN strategy (convex system and a seal) if they exhibit leakage, longer hospital stays, emergency surgery and previous use of open system and single-piece appliances. This combined treatment strategy can improve outcomes and satisfaction in patients with digestive ostomies and early effluent leakage.

Manuel Bona Sánchez, ET Nurse, Hospital Universitario Fundación Alcorcón , Madrid, Spain; Victoria Alejandra

López Callejón, ET Nurse, Hospital Clínico Universitario de Valencia, Spain; Irene Oto

Puyuelo, ET Nurse, Hospital

Miguel Servet, Zaragoza, Spain;

Mercedes Rubio Vázquez, ET Nurse, Hospital de la Santa Creu i Sant Pau. Barcelona, Spain;

Luisa Vázquez Burrero, ET Nurse, Hospital Juan Ramón

Jiménez, Huelva, Spain;

Eduardo García Blázquez, Market Manager Ostomy Care, Coloplast Productos

Médicos, Madrid, Spain esegb@coloplast.com

Patients who have undergone treatment for colorectal cancers and are subsequently living with an ostomy face numerous challenges (Claessens et al, 2015). These can include the frequency of ostomy pouch seal leakage, which can vary widely and cause significant worry and concern for patients. The consequences of pouch seal leakage can be severe, particularly in the early postoperative period, and can lead to skin damage, postoperative complications and patient distress (Voegeli et al, 2020).

People with an ostomy commonly experience peristomal skin conditions, which can have a significant impact on their quality of life. However, stoma care nurses can play a critical role in improving peristomal skin conditions, thereby reducing the negative impact of skin disorders on quality of life and minimising healthcare costs (Martins et al, 2011). According to a study by Rodríguez-González et al (2021a), reducing the frequency of leakages is a predictive factor for achieving optimal skin status in people with an ostomy.

Significant differences in the occurrence of ostomy pouch seal leakage have been reported across various regions and sanitary environments (Fellows et al, 2017). There is considerable variation in the use of ostomy appliances, which is partly determined by the financial burden associated with variability in reimbursement patterns for ostomy supplies among countries. Access to stoma therapist consultation and training for informal caregivers is particularly important, as they can help moderate the severity of challenges faced by patients, including their self-esteem, coping strategies and personal relationships (Rock et al, 2023). Structured ostomy care training has been shown to have a positive impact on the quality of life and anxiety levels of patients with a permanent ostomy (Khalilzadeh et al, 2019).

Another strategy to reduce effluent leakage is to switch to a new ostomy appliance, with consideration given to the use of a convex base plate to facilitate the protrusion of the stoma. Convex products are preferred for managing flat or retracted stomas and compensating for irregular peristomal planes, such as creases or folds (Hoeflok et al, 2017). Several studies have confirmed the benefits of flexible convex appliances in reducing leakage, providing security and improving comfort in ostomates with leakage (Kruse and Størling, 2015; Rat et al, 2018; Rodríguez-González et al, 2021b). Specifically, the ECOS (Convex in ostomy) study demonstrated that the efficacy and safety of using a convex light appliance are maintained long term (Rodríguez-González et al, 2021b).

A recent study has shown that in patients experiencing effluent leakage during the early postoperative period following an ostomy, changing to a light convex ostomy appliance combined with the use of a moldable ring is an effective strategy for improving peristomal skin condition and nursing assessment (NANDA-I) on specific domains (Lado Teso et al, 2022). This combination of strategies is designed to avoid the use of a hard convexity during the early postoperative period, which could potentially lead to stoma complications. However, not all patients may require this combined strategy of using a soft convexity and seal as an adjuvant measure. To identify the patient profile that would benefit the most from this combined strategy, the authors conducted a post-hoc analysis of the CONAN study, using a simple patient-reported outcome measurement.

Methods

The CONAN (convex light appliance and adaptable rings in ostomy) study is a prospective observational multicenter study that was conducted between January 2020 and July 2021 on patients who suffered from effluent leakage in the early postoperative period of a digestive ostomy in Spain. The study aimed to evaluate a representative sample from 54 participant institutions nationwide. The study’s required sample size was determined to be 250 cases, factoring in a precision of +/- 6.2% for the estimation of the 95% confidence interval for proportions. This calculation was based on the worst-case scenario of p=q=50% and a projected loss percentage of 2%.

The inclusion criteria selected patients who were able to perform a self-assessed evaluation of global wellbeing who were in the early postoperative period of an ostomy and suffered or were at risk of effluent leakage, and patients who gave signed informed consent to participate. Pregnancy or lactation and simultaneous participation in other studies were exclusion criteria, but previous or concomitant radiotherapy or chemotherapy were not.

The treatment involved changing the reference appliance to Easiflex Confort Convex Light (Coloplast A/S, Humlebæk, Denmark) combined with Brava (Coloplast A/S, Humlebæk, Denmark) moldable rings during the hospital admission. There were no exclusion criteria regarding the type and commercial design of the reference appliance system, but no patient included in the study had used a seal previously. Patients without a reference appliance, but considered by the investigator as patients at high risk of leakage, were also included. The main reasons for this included ostomy performed at emergency surgery without preoperative stoma siting, obesity and other morphological circumstances such as flat or retracted stomas and irregular peristomal planes with folds.

A total of 257 patients were screened, and 244 fulfilled the inclusion criteria and completed the evaluation. Patients who met the inclusion criteria were enrolled in the study in consecutive order and in a competitive manner across participating institutions. Treatment outcomes were evaluated during hospital admission at the time of inclusion (V1) and 2–3 weeks after discharge (V2). Patient-reported outcomes regarding satisfaction with reference to the appliance baseline and the CONAN treatment at the end of the study were evaluated using

Key words „

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Table 1. Baseline characteristics of the patients included (n=244)

were determinants of the best self-reported satisfaction with the light convex appliance and moldable ring. Odds ratios (OR) with 95% confidence intervals (CI) were defined for each independent predictor, and the area under the curve for the model was calculated. The statistical analysis was developed using SAS 9.4 (2002-2010, SAS Institute Inc, Cary, NC, US).

Results

Table 1 presents the demographic and baseline clinical characteristics of the 244 patients included in the study. All participants were patients in the early postoperative period of an ostomy. A total of 32 patients (13%) had no previous appliance and directly received a light convex one with a moldable ring because they were considered at high risk of leakage immediately following surgery. However, 212 (87%) suffered from effluent leakage with their previous reference appliance that was used for a mean of 6.5 ± 6.2 (range 1–60) days. Regarding the reference appliance, it was convex in 59 (28%) and flat in 153 (72%); the system was closed in 51 (24%) and open in 161 (76%) and the number of pieces was one in 37 (17%) and two in 175 (83%). In 27 patients, the two-piece ostomy pouch system also had mechanical coupling.

a 0–10 Likert scale. The number of effluent leakages per day were assessed numerically. The signed-rank t-test was used to compare changes in the number of leakage episodes per day and self-reported satisfaction between the initial (V1) and final (V2) visits, and also to compare quantitative variables. The Chi squared test test was used for comparison between categorical variables. The significance level considered was P<0.05.

Logistic regression analysis was used to identify the variables predictive of self-reported satisfaction ≥8. A multivariate analysis was performed using a stepwise model with a threshold entry of P=0.15 and a stay criterion of P=0.1 to evaluate variables that

The mean self-reported satisfaction changed from 5.1±2 in V1 to 7.2±1.7 in V2 with the light convex appliance plus moldable ring (t-test, P<.0001). The mean number of leakage episodes increased from 3.4±5.2 to 1.3 ± 2.3 (t-test, P<.0001). A correlation between self-reported satisfaction and the number of leakages, both baseline (Spearman coefficient: -0.35; P<0.0001) and at the end of the study (Spearman coefficient -0.38; P<0.0001) was confirmed.

The distribution of self-reported satisfaction during the study is shown in Figure 1 A total of 26 patients (11%) scored satisfaction ≥8 baseline, and 114 (47%) did so at the end of the study. High self-reported satisfaction (≥8 over 10) at the end of the study was associated with a shorter hospital admission (P=0.003) (Figure 2), lower body mass index (BMI) evaluated at V1 (P=0.04), lower number of leakages at V1 (P=0.04), the ability to change the appliance without the need of a caregiver

(P=0.03) and sealing system (P=0.005); but not to patient age (P=0.55), sex (P=0.96), type of ostomy (P=0.56), duration of ostomy (P=0.94), preoperative stoma siting (P=0.47) and type of reference appliance (p=0.29). The association between self-reported satisfaction with the type of surgery (P=0.08) and type of closure (P=0.06) approached statistical significance (Table 2).

A multivariate analysis was conducted to identify patient characteristics that may benefit more from the use of the study intervention. The analysis revealed that high self-reported satisfaction (≥8 out of 10) was associated with the length of hospital stay at the time of inclusion (OR=0.96 per day; 95% CI 0.92–0.99), programmed surgery compared to emergency surgery (OR=2.04; 95% CI 1.03–4.04), closed type ostomy appliance compared to an open one (OR=0.36; 95% CI 0.17–0.75) and number of pieces in the ostomy appliance system (OR=0.11; 95% CI 0.03–0.39) for two-piece systems with mechanical coupling compared to a single piece and (OR=0.27; 95% CI 0.11–0.69) for two-piece systems compared to a single piece. Table 3 and Figure 3 provide more details on the results. The area under the curve for this predictive model was 0.74, which represents the probability that the model correctly predicts future results.

Discussion

Ostomates often experience problems with their stoma, including leakage of effluent, which can cause irritation to the peristomal skin and pain (Lado Teso et al, 2019). The early postoperative period after an ostomy is a delicate time, and discharge concerns can severely impact adaptation to the stoma, leading to a reduction in social and recreational activities (Pieper and Mikols, 1996).

Several factors can contribute to pouch leakage, such as pouching skills, body habitus, risk of creases and irregular folds, preoperative stoma siting, inappropriate selection of products and incomplete patient or caregiver training. Early access to a consultation with a stoma therapist can help facilitate the adaptation process, as early recognition and prompt intervention in the case of complications are desirable (Richbourg et al, 2007; Butler, 2009 ).

More technically sophisticated stoma products, such as ostomy appliances with a convex baseplate, are now widely available. These appliances are increasingly used for all stoma types to facilitate maintenance of an active lifestyle in ostomates (McPhail et al, 2014). There is a strong consensus that convex ostomy appliances help to prevent

Hospital stay, as per day

leakage and skin irritation, as they create a secure seal for a stoma that does not protrude above the peristomal skin plane or when the peristomal skin has creases and folds (Hoeflok et al, 2017; McNichol et al, 2021; Perrin et al, 2021). Additionally, the use of convexity can be durable and secure in the long term, with a very manageable stoma-related complication rate (Rodríguez-González et al, 2021b).

Moldable skin barriers also appear effective in preventing and healing peristomal skin complications (Hoeflok et al, 2009; Szewcyk et al, 2014; Liu et al, 2017).

Although there is a strong consensus that patients with a flush retracted stoma benefit from convex appliances to prevent leaks, there are concerns that continuous, unmonitored strong convexity in the early postoperative period could lead to increased peristomal pressure, resulting in doubledepth skin trauma and a prolapsed stoma (Hanley and Hanley, 2013).

The CONAN study aimed to assess the effectiveness and safety of using a combination of tools – an appliance system with smooth convexity and a moldable ring – during the early postoperative period for patients with an ostomy experiencing leakage or at high risk of effluent leak. At a short follow-up of 2–3 weeks, this strategy not only reduced the number of leakages but also improved peristomal skin status and stoma morphology. Patients also reported improved quality of life and increased satisfaction (Lado Teso et al, 2022).

However, it is important to note that using the CONAN strategy of mild convexity and a seal right from the start of the postoperative period may not benefit all patients. It could increase the time and cost of care, changing the patient’s routine. Therefore, it is crucial to identify the patient population that would benefit the most from this therapeutic strategy, even before hospital discharge.

To address this need, the authors conducted a post-hoc evaluation of the CONAN study to describe the patient profile that benefits the most from this therapeutic strategy. Multivariate analysis of patient-reported outcome measurements revealed that high self-reported satisfaction (≥8 out of 10) was linked to the length of hospital stay at the time of inclusion in the study, whether the surgery was elective or an emergency, and the type of appliance used before study initiation (open system vs single-piece appliances). In other words, patients with worse reported outcome measures using the CONAN strategy were those with longer hospital stays, emergency surgeries, and open system or single-piece appliances. Therefore, this combined approach appears especially indicated in the early postoperative period of patients at higher risk of leakage and postoperative problems. According to the present study’s results, stoma nurses should consider the use of mild convexity and a seal in patients with longer hospital stays and effluent leakage, as well as those who had emergency surgeries without previous stoma siting, especially when irregular peristomal planes with creases and folds or retracted stomas are identified early after ostomy.

Emergency surgery is often associated with an inability to locate the stoma preoperatively, resulting in increased peristomal skin complications (Bueno Cruz et al, 2021). Shifting from a flat to a convex stoma appliance reduces effluent leakage (Rodríguez-González et al, 2021a) and the frequency of leakage determines peristomal skin status (Rodríguez González et al, 2021b). The regression analysis conducted confirmed that two-piece ostomy appliances (either with or without mechanical

Table 2. Variables associated with high self-reported satisfaction at V2

Table 3. Multivariate model for optimal self-reported satisfaction

CPD reflective questions

„ When consulting with a patient suffering frequent effluent leakage in the early postoperative period of an ostomy, what are the treatment options?

„ In this situation, would you consider the simultaneous use of a light convex appliance and moldable ring?

„ Is it possible to define a patient profile that benefits more of this combined strategy?

coupling) perform better than a single-piece reference. Baseline patients with two-piece systems and closed appliances experience higher satisfaction with the change to soft convexity and seal. In summary, the combined use of a convex light appliance and adaptable ring improves the circumstances creating a risk of effluent in terms of self-reported satisfaction. The authors also confirmed that this therapeutic strategy reduces the number of days of hospital admission and, at least in part, counteracts the negative factors that increase the risk of effluent leakage (obesity, stoma morphology and emergency surgery). Of course, the experience of the stoma care nurse is important in determining the optimal patient for this combined strategy.

Limitations

The main limitations of the present study are the absence of a control group and the short follow-up period. Another evident limitation is the absence of single treatment arms. While the authors confirmed that the combination of mild convexity with a seal is effective, further studies should be conducted to confirm whether the combination is better than one or the other measure alone. Future large-scale multicenter studies are needed to answer this question. On the other hand, the strengths of this study include its multicenter nature, the uniformity of the investigated intervention and the simplicity of the patient-reported outcome measurement used (self-reported satisfaction on a 0 to 10 VAS scale). The use of patient-reported outcome measures as endpoints is another strength of this study.

In Spain, the number of hospitals with specialised ostomy consultations has increased, offering early specialised attention and health education, thus providing psychological support from the first moment of an ostomy (Lado Teso et al, 2019). One way to improve education in the medical field is to expand the practice of marking stoma sites in a more generalised way. However, since a significant number of patients, over 40%, do not have a marked stoma site, personalised treatment and structured ostomy care training are still the key foundations of good medical practice in this area.

Conclusions

Patients who experience effluent leakage after undergoing ostomy surgery can benefit from using a light convex ostomy appliance and flexible rings in the early postoperative period. Certain individual factors such as length of hospital admission, emergency surgery and type of previous appliance used can predict which patients will have the best patient-reported outcomes with this therapeutic strategy (known as the CONAN strategy). Identifying these patients can help healthcare providers improve their care in the early postoperative period and reduce anxiety and fear experienced by patients after hospital discharge. More research with longer follow-up periods is needed to better understand how patient satisfaction with the use of soft convexity evolves over time after surgery. Patients with an ostomy need to receive care from a team of experts, including stoma therapy nurses, surgeons, psychologists, nutrition experts and other specialists. GN Declaration of interest: None. The study was performed on Coloplast’s request, who assumed the total cost of the study.

Ethical considerations: The research obtained ethical approval from the Ethics Committee of Clinical Investigation in Burgos and Soria (Burgos, Spain).

Financial disclosure: The CONAN study was supported by Coloplast Productos Médicos, S.A. (Madrid, Spain). The authors received economical support from Coloplast for specialist formation and have also participated in remunerated education initiatives as speakers. Contract research organisation, statistical analysis and medical writing were performed by PeRTICA statistical solutions.

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ACPN Annual Meeting, Manchester

3-4 July 2023

Monday 3 July 2023

Low Anterior Resection Syndrome: where are we now?

Chairs: Gabrielle Thorpe (Norwich), Jay Bradbury (Oxford)

◊An overview of the context of LARS - Nicola Fearnhead (Cambridge)

◊POLARIS research -Julie Cornish (Cardiff)

◊PhD research - Jennie Burch (London)

◊Patient perspective - Robin Johnston

◊Physio interventions - Kate Walsh (The Wirral)

Tuesday 4 July 2023

Annual General Meeting Short Paper Presentations

Mentoring Workshop

Michelle Crossland, Director Intuition Discovery and Development Ltd

This session will be a highly participative session designed to introduce you to the benefits of Mentoring as a means of supporting others in achieving personal and professional effectiveness and success. We will help you to understand what Mentoring is and what it isn’t.

You will be introduced to the essential skills and a mentoring model to support a mentoring conversation and given an opportunity to practice with your peers gasn.2015.13.5.18

Fellows J, Forest Lalande L, Martins L et al. Differences in ostomy pouch seal leakage occurrences between north American and European residents. J Wound Ostomy Continence Nurs. 2017;44(2):155–159. https://doi. org/10.1097/WON.0000000000000312

Khalilzadeh Ganjalikhani M, Tirgari B et al. Studying the effect of structured ostomy care training on quality of life and anxiety of patients with permanent ostomy. Int Wound J. 2019;16(6):1383–1390. https://doi. org/10.1111/iwj.13201

Hanley J. Convex stoma appliances: are we getting it right? Br J Nurs. 2013;22(Sup16):S3. https://doi.org/10.12968/ bjon.2013.22.Sup16.S3

Hoeflok J, Guy D, Allen S, St-Cyr D. A prospective multicenter evaluation of a moldable stoma skin barrier. Ostomy Wound Manage. 2009;55(5):62–69

Hoeflok J, Salvadalena G, Pridham S et al. Use of convexity in ostomy care. J Wound Ostomy Continence Nurs. 2017;44(1):55–62. https://doi.org/10.1097/ WON.0000000000000291

Kruse TM, Størling ZM. Considering the benefits of a new stoma appliance: a clinical trial. Br J Nurs. 2015;24(22):S12–S18. https://doi.org/10.12968/ bjon.2015.24.Sup22.S12

Lado Teso A, Fabeiro Mouriño MJ et al. Usos y actitudes de los pacientes ostomizados en España (Estudio U&A en Ostomía). Metas Enferm. 2019;22(4):19–27. https://doi. org/10.35667/MetasEnf.2019.22.1003081409

Lado Teso A, Del Pino C et al. Studying the effect of light convex appliance and adaptable rings in the early postoperative period of an intestinal ostomy with effluent leakage. Gastrointest Nurs. 2022. Forthcoming

Liu G, Chen Y, Luo J et al. The application of a moldable skin barrier in the self-care of elderly ostomy patients. Gastroenterol Nurs. 2017;40(2):117–120. https://doi. org/10.1097/SGA.0000000000000143

Martins L, Samai O, Fernández A et al. Maintaining healthy skin around an ostomy: peristomal skin disorders and self-assessment. Gastrointestinal Nurs. 2011; 9(Sup2):9–

13. https://doi.org/10.12968/gasn.2011.9.Sup2.9

McNichol L, Cobb T, Depaifve Y et al. Characteristics of convex skin barriers and clinical application. J Wound Ostomy Continence Nurs. 2021;48(6):524–532. https:// doi.org/10.1097/WON.0000000000000831

McPhail J, Nichols T, Menier M. A convex urostomy pouch with adhesive border: a patient survey. Br J Nurs. 2014;23(22):1182–1186. https://doi.org/10.12968/ bjon.2014.23.22.1182

Perrin A, White M, Burch J. Convexity in stoma care: developing a new ASCN UK guideline on the appropriate use of convex products. Br J Nurs. 2021;30(16):S12–S20. https://doi.org/10.12968/bjon.2021.30.16.S12

Pieper B, Mikols C. Predischarge and postdischarge concerns of persons with an ostomy. J Wound Ostomy Continence Nurs. 1996;23(2):105–109

Rat P, Robert N, Fernandes I et al. Evaluation of a one-piece soft convex ostomy appliance: a prospective, multicentre, open-label pilot study. Br J Nurs. 2018;27(16):S20–S28. https://doi.org/10.12968/bjon.2018.27.16.S20

Richbourg L, Thorpe JM, Rapp CG. Difficulties experienced by the ostomate after hospital discharge. J Wound Ostomy Continence Nurs. 2007;34(1):70–79. https://doi. org/10.1097/00152192-200701000-00011

Rodriguez-González E, Zurita CDP, Caballero GA. Factors predictive of optimal peristomal skin status in patients with an ostomy: a secondary analysis. Br J Community Nurs. 2021a;26(Sup12):S24–S34. https://doi. org/10.12968/bjcn.2021.26.Sup12.S24

Rodriguez-González E, del Pino Zurita C et al. Impact of convex ostomy appliances on leakage frequency, peristomal skin health and stomal protrusion. Gastrointest Nurs. 2021b;19(Sup9):S30–S37. https://doi. org/10.12968/gasn.2021.19.Sup9.S30

Rock M, Kieserman JM, Sun V et al. Clinical and demographic differences among cancer survivors with ostomies with and without informal caregivers. J Cancer Educ. 2023;38(2):455–461. https://doi.org/10.1007/ s13187-022-02139-x

Szewczyk MT, Majewska G, Cabral MV, Hölzel-Piontek K. The effects of using a moldable skin barrier on peristomal skin condition in persons with an ostomy: results of a prospective, observational, multinational study. Ostomy Wound Manage. 2014;60(12):16–26

Voegeli D, Karlsmark T, Eddes EH et al. Factors influencing the incidence of peristomal skin complications: evidence from a multinational survey on living with a stoma. Gastrointest Nurs. 2020;18(Sup4) S4:S31–S38. https://doi.org/10.12968/gasn.2020.18.Sup4.S31

INDICATED IN:

Autoimmune Hepatitis

For induction and maintenance of remission

Budesonide, the Dr Falk way

3mg Capsules

CROHN’S DISEASE

For induction of remission of mild to moderate active ileo-caecal Crohn’s disease

Microscopic Colitis

For induction and maintenance of remission

Prescribing Information (Refer to full SPC before prescribing)

Presentation: Budenofalk® gastro-resistant capsules, each containing 3mg budesonide, 240mg sucrose and 12mg lactose monohydrate. Budenofalk® gastro-resistant granules, each sachet contains 9mg budesonide, 828mg sucrose, 36mg lactose monohydrate and 900mg sorbitol. Indications: Capsules: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Microscopic colitis. Autoimmune hepatitis. Granules: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission in patients with active microscopic colitis in adults aged ≥ 18 years. Dosage: All - take with a glass of water half an hour before meals. Take once-daily doses in the morning.

Adults: Capsules: Crohn’s disease: 9mg once daily or 3mg three times a day. Microscopic colitis: Induction of remission: 9mg once daily. Maintenance: lowest effective dose - 6mg once daily or 6mg once daily alternating with 3mg once daily. Autoimmune hepatitis: induction of remission: 3mg three times a day. Maintenance: 3mg twice a day. Increase back to 9mg daily if ALAT &/or ASAT increase. Granules: Crohn’s disease and induction of remission in microscopic colitis: 9mg once daily in the morning.

Duration of treatment: Induction: Crohn’s disease, microscopic colitis: 8 weeks. Autoimmune hepatitis - until remission is achieved then maintenance for at least 24 months. Do not stop any treatment abruptly but taper gradually. Contra-indications: hypersensitivity to any constituent. Hepatic cirrhosis. Warnings/Precautions: Change from other steroids may result in symptoms due to reduced systemic steroids. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes or any condition in which glucocorticosteroids may have undesirable effects. Not appropriate for upper GI Crohn’s or extraintestinal symptoms. Prolonged, high dose use may result in glucocorticosteroid systemic effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. Clinical presentation of infections may be atypical and presentation of serious infections may be masked. Chickenpox and herpes zoster are of particular concern. Passive immunisation needed within 10 days in exposed non-immune patients taking systemic glucocorticosteroids. Urgent specialist care required on confirmed chickenpox. Give normal immunoglobulin immediately after measles exposure. Do not give live vaccines to those with chronic glucocorticosteroid use. Antibody response to other vaccines may be diminished. With severe liver function disorders: increased systemic bioavailability expected. Central serous chorioretinopathy or other causes may result in blurred vision/visual disturbances. Consider referral to ophthalmologist. Suppression of the HPA axis and reduced stress response: supplementary systemic glucocorticoid treatment may be needed. Avoid concomitant treatment with CYP3A4 inhibitors. Do not use in patients with galactose or fructose intolerance, glucose –galactose malabsorption, sucrase – isomaltase insufficiency or total lactase deficiency or congenital lactase deficiency. In autoimmune hepatitis evaluate transaminase levels every 2 weeks for the first month and then every 3 months. Interactions: Co-treatment with CYP3A inhibitors including cobicistat containing products may increase side effects and should be avoided where possible. Beware concomitant administration of cardiac glycosides and saluretics. CYP3A4 inducers: may reduce systemic and local exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates: may compete with budesonide increasing plasma concentrations depending on relative affinities. Small, non-significant effect of cimetidine on budesonide kinetic effects. Oestrogens/oral contraceptives (not oral low dose combination contraceptives) may elevate plasma concentrations and enhance corticosteroid effects. Steroid-binding compounds and antacids may reduce budesonide efficacy; administer at least 2 hours apart. Because adrenal function may be supressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Avoid use in pregnancy unless essential. Do not breastfeed during Budenofalk treatment. Undesirable effects: Cushing’s syndrome, growth retardation in children, glaucoma, cataracts, blurred vision, dyspepsia, abdominal pain, constipation, gastric or duodenal ulcers, pancreatitis, increase in risk of infections, muscle and joint pain and weakness and twitching, osteoporosis, osteonecrosis, headache, pseudotumor cerebri (including papilloedema) in adolescents, depression, irritability and euphoria, psychomotor hyperactivity, anxiety, aggression, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing, increased risk of thrombosis, vasculitis (after withdrawal from long-term treatment), fatigue, malaise. Side effects characteristic of systemic glucocorticosteroid therapy may occur. Exacerbation or reappearance of extraintestinal manifestations when switching from

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For localised e cacy and minimised steroid-speci c side e ects1-5 systemically acting glucocorticosteroids may occur. Frequency is likely to be lower than with equivalent dosage of prednisolone. Legal category: POM.

Costs: UK NHS: 60 sachets £135; 100 capsules £75.05. Ireland (PtW): 60 sachets: €145.84; 100 capsules: €78.50. Licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Licence numbers: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules) PL08637/0002 (UK) PA573/2/1 (IE).

Prepared: January 2023

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References:

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2. Miehlke S et al. Gastroenterology 2014; 146(5): 1222-30.

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Abbreviation:

GI: gastrointestinal

Date of preparation: March 2023 UI--2300069