Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema

S. Ardizzone, P. Doldo, T. Ranzi, G. C. Sturniolo, L. A. Giglio, V. Annese, A. D'Arienzo, E. Gaia, S. Gullini, G. Riegler, M. Valentini, P. Massa, M. Del Piano, F. Rossini, C. Sategna Guidetti, A. Pera, R. Greinwald, G. Bianchi Porro, A. Andriulli, G. Lombardi & 23 others S. G. Rotondo, M. T. Fiorentini, G. Caula, S. B. Grosso, M. Pennazio, M. Cavallero, R. Cosintino, C. Prantera, A. Sambataro, M. Gallo, G. Scaglione, R. Bennato, D. Cantarini, M. Orsello, P. A. Bianchi, L. Piodi, M. Fornasarig, T. Parrello, F. Pallone, R. D'Inca, A. Ferronato, F. Morace, M. T. Tartaglione

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background. Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability. Aim. To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk® foam) with mesalazine enema in the treatment of active distal ulcerative colitis. Patients and Methods. A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI ≥ 4) and Endoscopic Index (EI ≥ 6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks. Results. A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with a least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n = 89 foam, n = 96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests. Conclusions. Salofalk® foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.

Original languageEnglish
Pages (from-to)677-684
Number of pages8
JournalItalian Journal of Gastroenterology and Hepatology
Volume31
Issue number8
Publication statusPublished - 1999

Fingerprint

Mesalamine
Enema
Ulcerative Colitis
Therapeutics
Proctocolitis
Proctitis
carboxyamido-triazole
Multicenter Studies

Keywords

  • Mesalazine
  • Rectal foam
  • Topical treatment
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Ardizzone, S., Doldo, P., Ranzi, T., Sturniolo, G. C., Giglio, L. A., Annese, V., ... Tartaglione, M. T. (1999). Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema. Italian Journal of Gastroenterology and Hepatology, 31(8), 677-684.

Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema. / Ardizzone, S.; Doldo, P.; Ranzi, T.; Sturniolo, G. C.; Giglio, L. A.; Annese, V.; D'Arienzo, A.; Gaia, E.; Gullini, S.; Riegler, G.; Valentini, M.; Massa, P.; Del Piano, M.; Rossini, F.; Sategna Guidetti, C.; Pera, A.; Greinwald, R.; Bianchi Porro, G.; Andriulli, A.; Lombardi, G.; Rotondo, S. G.; Fiorentini, M. T.; Caula, G.; Grosso, S. B.; Pennazio, M.; Cavallero, M.; Cosintino, R.; Prantera, C.; Sambataro, A.; Gallo, M.; Scaglione, G.; Bennato, R.; Cantarini, D.; Orsello, M.; Bianchi, P. A.; Piodi, L.; Fornasarig, M.; Parrello, T.; Pallone, F.; D'Inca, R.; Ferronato, A.; Morace, F.; Tartaglione, M. T.

In: Italian Journal of Gastroenterology and Hepatology, Vol. 31, No. 8, 1999, p. 677-684.

Research output: Contribution to journalArticle

Ardizzone, S, Doldo, P, Ranzi, T, Sturniolo, GC, Giglio, LA, Annese, V, D'Arienzo, A, Gaia, E, Gullini, S, Riegler, G, Valentini, M, Massa, P, Del Piano, M, Rossini, F, Sategna Guidetti, C, Pera, A, Greinwald, R, Bianchi Porro, G, Andriulli, A, Lombardi, G, Rotondo, SG, Fiorentini, MT, Caula, G, Grosso, SB, Pennazio, M, Cavallero, M, Cosintino, R, Prantera, C, Sambataro, A, Gallo, M, Scaglione, G, Bennato, R, Cantarini, D, Orsello, M, Bianchi, PA, Piodi, L, Fornasarig, M, Parrello, T, Pallone, F, D'Inca, R, Ferronato, A, Morace, F & Tartaglione, MT 1999, 'Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema', Italian Journal of Gastroenterology and Hepatology, vol. 31, no. 8, pp. 677-684.
Ardizzone, S. ; Doldo, P. ; Ranzi, T. ; Sturniolo, G. C. ; Giglio, L. A. ; Annese, V. ; D'Arienzo, A. ; Gaia, E. ; Gullini, S. ; Riegler, G. ; Valentini, M. ; Massa, P. ; Del Piano, M. ; Rossini, F. ; Sategna Guidetti, C. ; Pera, A. ; Greinwald, R. ; Bianchi Porro, G. ; Andriulli, A. ; Lombardi, G. ; Rotondo, S. G. ; Fiorentini, M. T. ; Caula, G. ; Grosso, S. B. ; Pennazio, M. ; Cavallero, M. ; Cosintino, R. ; Prantera, C. ; Sambataro, A. ; Gallo, M. ; Scaglione, G. ; Bennato, R. ; Cantarini, D. ; Orsello, M. ; Bianchi, P. A. ; Piodi, L. ; Fornasarig, M. ; Parrello, T. ; Pallone, F. ; D'Inca, R. ; Ferronato, A. ; Morace, F. ; Tartaglione, M. T. / Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema. In: Italian Journal of Gastroenterology and Hepatology. 1999 ; Vol. 31, No. 8. pp. 677-684.
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title = "Mesalazine foam (Salofalk{\circledR} foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko{\circledR} enema",
abstract = "Background. Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability. Aim. To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk{\circledR} foam) with mesalazine enema in the treatment of active distal ulcerative colitis. Patients and Methods. A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI ≥ 4) and Endoscopic Index (EI ≥ 6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks. Results. A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41{\%} of patients on enema received such treatment vs only 29{\%} of those on foam. Patients with a least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n = 89 foam, n = 96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54{\%} of patients treated with foam and in 67{\%} of those treated with enema. The 90{\%} confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70{\%} of patients switched to foam were in remission vs 65{\%} to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests. Conclusions. Salofalk{\circledR} foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.",
keywords = "Mesalazine, Rectal foam, Topical treatment, Ulcerative colitis",
author = "S. Ardizzone and P. Doldo and T. Ranzi and Sturniolo, {G. C.} and Giglio, {L. A.} and V. Annese and A. D'Arienzo and E. Gaia and S. Gullini and G. Riegler and M. Valentini and P. Massa and {Del Piano}, M. and F. Rossini and {Sategna Guidetti}, C. and A. Pera and R. Greinwald and {Bianchi Porro}, G. and A. Andriulli and G. Lombardi and Rotondo, {S. G.} and Fiorentini, {M. T.} and G. Caula and Grosso, {S. B.} and M. Pennazio and M. Cavallero and R. Cosintino and C. Prantera and A. Sambataro and M. Gallo and G. Scaglione and R. Bennato and D. Cantarini and M. Orsello and Bianchi, {P. A.} and L. Piodi and M. Fornasarig and T. Parrello and F. Pallone and R. D'Inca and A. Ferronato and F. Morace and Tartaglione, {M. T.}",
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TY - JOUR

T1 - Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema

AU - Ardizzone, S.

AU - Doldo, P.

AU - Ranzi, T.

AU - Sturniolo, G. C.

AU - Giglio, L. A.

AU - Annese, V.

AU - D'Arienzo, A.

AU - Gaia, E.

AU - Gullini, S.

AU - Riegler, G.

AU - Valentini, M.

AU - Massa, P.

AU - Del Piano, M.

AU - Rossini, F.

AU - Sategna Guidetti, C.

AU - Pera, A.

AU - Greinwald, R.

AU - Bianchi Porro, G.

AU - Andriulli, A.

AU - Lombardi, G.

AU - Rotondo, S. G.

AU - Fiorentini, M. T.

AU - Caula, G.

AU - Grosso, S. B.

AU - Pennazio, M.

AU - Cavallero, M.

AU - Cosintino, R.

AU - Prantera, C.

AU - Sambataro, A.

AU - Gallo, M.

AU - Scaglione, G.

AU - Bennato, R.

AU - Cantarini, D.

AU - Orsello, M.

AU - Bianchi, P. A.

AU - Piodi, L.

AU - Fornasarig, M.

AU - Parrello, T.

AU - Pallone, F.

AU - D'Inca, R.

AU - Ferronato, A.

AU - Morace, F.

AU - Tartaglione, M. T.

PY - 1999

Y1 - 1999

N2 - Background. Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability. Aim. To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk® foam) with mesalazine enema in the treatment of active distal ulcerative colitis. Patients and Methods. A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI ≥ 4) and Endoscopic Index (EI ≥ 6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks. Results. A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with a least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n = 89 foam, n = 96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests. Conclusions. Salofalk® foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.

AB - Background. Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability. Aim. To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk® foam) with mesalazine enema in the treatment of active distal ulcerative colitis. Patients and Methods. A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI ≥ 4) and Endoscopic Index (EI ≥ 6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks. Results. A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with a least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n = 89 foam, n = 96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests. Conclusions. Salofalk® foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.

KW - Mesalazine

KW - Rectal foam

KW - Topical treatment

KW - Ulcerative colitis

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