Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey

E Wedgeworth; M Glover; A D Irvine; I Neri; E Baselga; T H Clayton; P E Beattie; J V Bjerre; N P Burrows; R Foelster-Holst; L Hedelund; A Hernandez-Martin; H Audrain; K Bhate; S J Brown; S Baryschpolec; S Darne; A Durack; V Dvorakova; J Gach; N Goldstraw; H Goodyear; S Grabczynska; D Greenblatt; J Halpern; R M R Hearn; S Hoey; B Hughes; R Jayaraj; E K Johansson; M Lam; S Leech; G M O'Regan; D Morrison; W Porter; R Ramesh; T Schill; L Shaw; A E M Taylor; R Taylor; J Thomson; P Tiffin; M Tsakok; S R Janmohamed; B Laguda; T McPherson; A P Oranje; A Patrizi; J C Ravenscroft; H Shahidullah; L Solman; A Svensson; C F Wahlgren; P H Hoeger; C Flohr

doi:10.1111/bjd.14233

Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey

E Wedgeworth, M Glover, A D Irvine, I Neri, E Baselga, T H Clayton, P E Beattie, J V Bjerre, N P Burrows, R Foelster-Holst, L Hedelund, A Hernandez-Martin, H Audrain, K Bhate, S J Brown, S Baryschpolec, S Darne, A Durack, V Dvorakova, J GachN Goldstraw, H Goodyear, S Grabczynska, D Greenblatt, J Halpern, R M R Hearn, S Hoey, B Hughes, R Jayaraj, E K Johansson, M Lam, S Leech, G M O'Regan, D Morrison, W Porter, R Ramesh, T Schill, L Shaw, A E M Taylor, R Taylor, J Thomson, P Tiffin, M Tsakok, S R Janmohamed, B Laguda, T McPherson, A P Oranje, A Patrizi, J C Ravenscroft, H Shahidullah, L Solman, A Svensson, C F Wahlgren, P H Hoeger, C Flohr (Lead / Corresponding author)

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Abstract

BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres.

OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs.

METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool.

RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001.

CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.

Original language	English
Pages (from-to)	594-601
Number of pages	8
Journal	British Journal of Dermatology
Volume	174
Issue number	3
Early online date	16 Oct 2015
DOIs	https://doi.org/10.1111/bjd.14233
Publication status	Published - Mar 2016

Keywords

Administration, Oral
Antineoplastic agents
Dose-response relationship, Drug
Female
Hemangioma
Humans
Infant
Male
Propranolol
Skin neoplasms
treatment outcome
Journal article
Multicenter study
Observational study
Research support, Non-U.S. Gov't

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Wedgeworth, E., Glover, M., Irvine, A. D., Neri, I., Baselga, E., Clayton, T. H., Beattie, P. E., Bjerre, J. V., Burrows, N. P., Foelster-Holst, R., Hedelund, L., Hernandez-Martin, A., Audrain, H., Bhate, K., Brown, S. J., Baryschpolec, S., Darne, S., Durack, A., Dvorakova, V., ... Flohr, C. (2016). Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey. British Journal of Dermatology, 174(3), 594-601. https://doi.org/10.1111/bjd.14233

@article{3dd7ef08e504462da1e7adfaec9dd563,

title = "Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey",

abstract = "BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres.OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs.METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool.RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001.CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.",

keywords = "Administration, Oral, Antineoplastic agents, Dose-response relationship, Drug, Female, Hemangioma, Humans, Infant, Male, Propranolol, Skin neoplasms, treatment outcome, Journal article, Multicenter study, Observational study, Research support, Non-U.S. Gov't",

author = "E Wedgeworth and M Glover and Irvine, {A D} and I Neri and E Baselga and Clayton, {T H} and Beattie, {P E} and Bjerre, {J V} and Burrows, {N P} and R Foelster-Holst and L Hedelund and A Hernandez-Martin and H Audrain and K Bhate and Brown, {S J} and S Baryschpolec and S Darne and A Durack and V Dvorakova and J Gach and N Goldstraw and H Goodyear and S Grabczynska and D Greenblatt and J Halpern and Hearn, {R M R} and S Hoey and B Hughes and R Jayaraj and Johansson, {E K} and M Lam and S Leech and O'Regan, {G M} and D Morrison and W Porter and R Ramesh and T Schill and L Shaw and Taylor, {A E M} and R Taylor and J Thomson and P Tiffin and M Tsakok and Janmohamed, {S R} and B Laguda and T McPherson and Oranje, {A P} and A Patrizi and Ravenscroft, {J C} and H Shahidullah and L Solman and A Svensson and Wahlgren, {C F} and Hoeger, {P H} and C Flohr",

note = "This study had no specific funding. C.F. holds a U.K. National Institute for Health Research (NIHR) Career Development Fellowship (CDF-2014-07-037). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR or the U.K. Department of Health. S.J.B. holds a Wellcome Trust Intermediate Clinical Fellowship (086398/Z/08/Z).",

year = "2016",

month = mar,

doi = "10.1111/bjd.14233",

language = "English",

volume = "174",

pages = "594--601",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Oxford University Press",

number = "3",

}

Wedgeworth, E, Glover, M, Irvine, AD, Neri, I, Baselga, E, Clayton, TH, Beattie, PE, Bjerre, JV, Burrows, NP, Foelster-Holst, R, Hedelund, L, Hernandez-Martin, A, Audrain, H, Bhate, K, Brown, SJ, Baryschpolec, S, Darne, S, Durack, A, Dvorakova, V, Gach, J, Goldstraw, N, Goodyear, H, Grabczynska, S, Greenblatt, D, Halpern, J, Hearn, RMR, Hoey, S, Hughes, B, Jayaraj, R, Johansson, EK, Lam, M, Leech, S, O'Regan, GM, Morrison, D, Porter, W, Ramesh, R, Schill, T, Shaw, L, Taylor, AEM, Taylor, R, Thomson, J, Tiffin, P, Tsakok, M, Janmohamed, SR, Laguda, B, McPherson, T, Oranje, AP, Patrizi, A, Ravenscroft, JC, Shahidullah, H, Solman, L, Svensson, A, Wahlgren, CF, Hoeger, PH & Flohr, C 2016, 'Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey', British Journal of Dermatology, vol. 174, no. 3, pp. 594-601. https://doi.org/10.1111/bjd.14233

TY - JOUR

T1 - Propranolol in the treatment of infantile haemangiomas

T2 - lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey

AU - Wedgeworth, E

AU - Glover, M

AU - Irvine, A D

AU - Neri, I

AU - Baselga, E

AU - Clayton, T H

AU - Beattie, P E

AU - Bjerre, J V

AU - Burrows, N P

AU - Foelster-Holst, R

AU - Hedelund, L

AU - Hernandez-Martin, A

AU - Audrain, H

AU - Bhate, K

AU - Brown, S J

AU - Baryschpolec, S

AU - Darne, S

AU - Durack, A

AU - Dvorakova, V

AU - Gach, J

AU - Goldstraw, N

AU - Goodyear, H

AU - Grabczynska, S

AU - Greenblatt, D

AU - Halpern, J

AU - Hearn, R M R

AU - Hoey, S

AU - Hughes, B

AU - Jayaraj, R

AU - Johansson, E K

AU - Lam, M

AU - Leech, S

AU - O'Regan, G M

AU - Morrison, D

AU - Porter, W

AU - Ramesh, R

AU - Schill, T

AU - Shaw, L

AU - Taylor, A E M

AU - Taylor, R

AU - Thomson, J

AU - Tiffin, P

AU - Tsakok, M

AU - Janmohamed, S R

AU - Laguda, B

AU - McPherson, T

AU - Oranje, A P

AU - Patrizi, A

AU - Ravenscroft, J C

AU - Shahidullah, H

AU - Solman, L

AU - Svensson, A

AU - Wahlgren, C F

AU - Hoeger, P H

AU - Flohr, C

N1 - This study had no specific funding. C.F. holds a U.K. National Institute for Health Research (NIHR) Career Development Fellowship (CDF-2014-07-037). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR or the U.K. Department of Health. S.J.B. holds a Wellcome Trust Intermediate Clinical Fellowship (086398/Z/08/Z).

PY - 2016/3

Y1 - 2016/3

N2 - BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres.OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs.METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool.RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001.CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.

AB - BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres.OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs.METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool.RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001.CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.

KW - Administration, Oral

KW - Antineoplastic agents

KW - Dose-response relationship, Drug

KW - Female

KW - Hemangioma

KW - Humans

KW - Infant

KW - Male

KW - Propranolol

KW - Skin neoplasms

KW - treatment outcome

KW - Journal article

KW - Multicenter study

KW - Observational study

KW - Research support, Non-U.S. Gov't

U2 - 10.1111/bjd.14233

DO - 10.1111/bjd.14233

M3 - Article

C2 - 26473312

SN - 0007-0963

VL - 174

SP - 594

EP - 601

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 3

ER -

Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce survey

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