Rapid onset of action of calcipotriol/betamethasone dipropionate cutaneous foam in psoriasis, even in patients with more severe disease
A.E. Pink A. Jalili P. Berg P.G. Calzavara‐Pinton P. de la Cueva Dobao D. Thaçi M. Torpet K.L. Jensen S. Segaert
First published: 27 March 2019 https://doi.org/10.1111/jdv.15398
Conflicts of interest Andrew Pink has served as an advisor, steering group member or lectured for Almirall, LEO Pharma, Lilly, Sanofi, Novartis and La Roche‐Posay. Ahmad Jalili has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, GSK, LEO Pharma, Janssen‐Cilag, MSD, Novartis and Sanofi. Peter Berg has been a consultant and advisor, and/or received speaking fees, and/or served as an investigator in clinical trials for the following companies: AbbVie, A‐Derma, Almirall, Amgen, Astra Zeneca, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, Johnson/Johnson, Merck Serono, MSD, Novartis, Pfizer and UCB. Piergiacomo Calzavara‐Pinton has served as an advisory board member or lectured for Galderma, Almirall, LEO Pharma, Sanofi, Meda and AbbVie. Pablo de la Cueva Dobao has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Almirall, Astellas, Biogen, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and UCB. Diamant Thaçi has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Dignity, Dermavant, Eli Lilly, Galapagos, Galderma, GSK, LEO Pharma, Janssen‐Cilag, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. Mathias Torpet and Katrine Jensen are employees of LEO Pharma A/S. Siegfried Segaert has been a paid speaker or consultant for Abbott, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galderma, Glenmark, Janssen, LEO Pharma, Lilly, Merck Serono, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sun Pharma and UCB.
Funding source This study was sponsored by LEO Pharma.
This manuscript contains original unpublished work and has not been submitted for publication elsewhere. Some of these data have previously been presented in poster format at the 27th European Academy of Dermatology and Venereology Congress 2018 P1852.
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Abstract
Background
The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health‐related quality of life (HRQoL) are important influencers of adherence.
Methods
This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed‐dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild‐to‐severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets.
Results
A greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006).
Conclusion
We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness.
A.E. Pink A. Jalili P. Berg P.G. Calzavara‐Pinton P. de la Cueva Dobao D. Thaçi M. Torpet K.L. Jensen S. Segaert
First published: 27 March 2019 https://doi.org/10.1111/jdv.15398
Conflicts of interest Andrew Pink has served as an advisor, steering group member or lectured for Almirall, LEO Pharma, Lilly, Sanofi, Novartis and La Roche‐Posay. Ahmad Jalili has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, GSK, LEO Pharma, Janssen‐Cilag, MSD, Novartis and Sanofi. Peter Berg has been a consultant and advisor, and/or received speaking fees, and/or served as an investigator in clinical trials for the following companies: AbbVie, A‐Derma, Almirall, Amgen, Astra Zeneca, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, Johnson/Johnson, Merck Serono, MSD, Novartis, Pfizer and UCB. Piergiacomo Calzavara‐Pinton has served as an advisory board member or lectured for Galderma, Almirall, LEO Pharma, Sanofi, Meda and AbbVie. Pablo de la Cueva Dobao has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Almirall, Astellas, Biogen, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and UCB. Diamant Thaçi has been a consultant and advisor, and/or received speaking fees and/or grants, and/or served as an investigator in clinical trials for the following companies: AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Dignity, Dermavant, Eli Lilly, Galapagos, Galderma, GSK, LEO Pharma, Janssen‐Cilag, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB. Mathias Torpet and Katrine Jensen are employees of LEO Pharma A/S. Siegfried Segaert has been a paid speaker or consultant for Abbott, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galderma, Glenmark, Janssen, LEO Pharma, Lilly, Merck Serono, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sun Pharma and UCB.
Funding source This study was sponsored by LEO Pharma.
This manuscript contains original unpublished work and has not been submitted for publication elsewhere. Some of these data have previously been presented in poster format at the 27th European Academy of Dermatology and Venereology Congress 2018 P1852.
Read the full text
ePDFPDFTOOLS SHARE
Abstract
Background
The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health‐related quality of life (HRQoL) are important influencers of adherence.
Methods
This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed‐dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild‐to‐severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets.
Results
A greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006).
Conclusion
We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness.
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