Results of the long-term observational noninterventional prospective study BODYGUARD in psoriasis patients

Cover Page

Cite item


Introduction. Currently there is insufficient data regarding routine use of various topical treatments for plaque psoriasis outside from randomized clinical trials, their efficacy, cost-effectiveness and perception by dermatologists and patients. The primary rationale for this study was local data generation for the long-term (up to 52 weeks) treatment of body psoriasis in Russian patients’ population with fixed-dose combination of calcipotriol and betamethasone dipropionate in the formulation of gel to evaluate patient’s adherence to the therapy and their satisfaction level.

Materials and methods. Primary study objectives were evaluation of the long-term (up to 52 weeks) treatment success of body psoriasis with fixed-dose combination of calcipotriol and betamethasone dipropionate gel by Physician (Physician Psoriasis Global Assessment (PsGA, 5-point scale)) and by patient (Patient’s Global Psoriasis Assessment (PaGA, 5-point scale) and overall patient’s satisfaction using 4-point scale), patient’s satisfaction with the treatment via Patient Preference Questionnaire (PPQ), patients’ adherence to the treatment using Questionnaire of Adherence, impact of treatment on patients’ quality of life using DLQI questionnaire, and patients’ readiness to buy topical therapy product out of pocket based on consumption of the study medication during follow up period. Patients received treatment with topical calcipotriol/betamethasone gel which was prescribed as a routine medication without connection to the study purposes for up to 8 weeks. After the treatment patients were followed up for up to 52 weeks; during this period they were allowed to continue treatment with either maintenance or intermittent schedule. 128 dermatologists participated in the study, 612 patients with body plaque psoriasis (mean age 42.0 ± 13.30 years) were included; from this sample 544 (88.7 %) patients underwent follow up.

Results. All 612 included patients received initial therapy with calcipotriol/betamethasone gel; during follow-up period 410 (76.1 %) patients received treatment by any schedule (out of 539 assessed). Overall treatment success based on average PsGA score: initially 3.0 ± 0.54, after appr.8 weeks — 1.3 ± 0.80 and after appr.52 week 1.1 ± 0.96; based on average PaGA score — initially 3.0 ± 0.54, after appr.8 weeks — 1.5 ± 0.88 and after appr.52 week 1.1 ± 0.99. The proportion of patients which described their overall satisfaction with the treatment as “satisfied” or “absolutely satisfied” equaled 92.3 % at visit at the end of active treatment and 93.1 % at visit up to 52 weeks afterwards. Also at visit at the end of active treatment 93.8 % of patients considered their current treatment as “more effective” than previous topical treatment they received. Patients’ adherence to the therapy was satisfactory — average application rate of calcipotriol/betamethasone (should be applied daily) gel at the last 7 days of treatment at visit at the end of active treatment comprised 5.6 ± 2.6 days, which means that 6 out of 7 days of the treatment were not missed. Initial DLQI score was 13.6 ± 5.95 and it reduced down to 3.89 ± 5.95 at visit at the end of active treatment (p < 0.001) reflecting positive impact of successful therapy on patients’ psychosocial wellbeing.

Discussion. Results of this study provides additional information regarding routine topical therapy in patients with plaque psoriasis. These findings demonstrate that the therapy of body plaque psoriasis with calcipotriol/betamethasone gel is effective both in short and long term according to the evaluation by dermatologists and by patients themselves. This therapy provides good rate of adherence and patients’ satisfaction as well as affects positively at patients’ psychosocial wellbeing assessed by DLQI score. 

About the authors

A. L. Bakulev

Saratov State Medical University named after V. I. Razumovsky, Ministry of Health of the Russian Federation

Author for correspondence.

Dr. Sci. (Med.), Prof., Head of the Department of Dermatovenerology and Cosmetology,

Bolshaya Kazachya str., 112, Saratov, 410012

Russian Federation

D. D. Petrunin

LEO Pharmaceutical Products, LLC


Cand. Sci. (Med.), Medical & Scientific Affairs Manager,

Leningradsky prospect, 72, korpus 2, Moscow, 125315

Russian Federation


  1. Кубанова А. А., Кубанов А. А., Знаменская Л. Ф., Чикин В.В., Бакулев А. Л., Хобейш М. М. и др. Псориаз. В кн.: Федеральные клинические рекомендации. Дерматовенерология, 2015: Болезни кожи. Инфекции, передаваемые половым путем. 5-е изд., перераб. и доп. М.: Деловой экспресс, 2016. С. 415–470.
  2. Langley R. G. Exploring new concepts in the successful management of psoriasis. J Eur Acad Dermatol Venereol. 2012 Mar;26(Suppl 2):1–2.
  3. Mrowietz U. Implementing treatment goals for successful longterm management of psoriasis. J Eur Acad Dermatol Venereol. 2012 Mar;26(Suppl 2):12–20.
  4. Armstrong A. W., Siegel M. P., Bagel J. et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. Published online Nov. 28, 2016. doi: 10.1016/j.jaad.2016.10.017
  5. Nast A., Jacobs A., Rosumeck S., Werner R. Methods Report: European S3. Guidelines on the systemic treatment of psoriasis vulgaris — update 2015 — EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29:e1–e22. doi: 10.1111/jdv.13353
  6. Smith C. H. T., Jabbar-Lopez Z. K., MacMahon E. et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017;177:628–636. doi: 10.1111/bjd.15665
  7. Kaufmann R., Bibby A. J., Bissonnette R., Cambazard F., Chu A. C., Decroix J. et al. A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology. 2002;205(4):389–393.
  8. Douglas W. S., Poulin Y., Decroix J., Ortonne J. P., Mrowietz U., Gulliver W. et al. A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris. Acta Derm Venereol. 2002;82(2):131–135.
  9. Mason A. R., Mason J., Cork M., Dooley G., Hancock H. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD005028.
  10. Norris D. A. A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris. J Am Acad Dermatol. 2005 Jul;53(1. Suppl 1):S17–25.
  11. Segaert S., Ropke M. The biological rationale for use of vitamin d analogs in combination with corticosteroids for the topical treatment of plaque psoriasis. J Drugs Dermatol. 2013 Aug;12(8):e129–e137.
  12. Lange K., Kleuser B., Gysler A., Bader M., Maia C., Scheidereit C. et al. Cutaneous inflammation and proliferation in vitro: differential effects and mode of action of topical glucocorticoids. Skin Pharmacol Appl Skin Physiol. 2000 Mar-Apr;13(2):93–103.
  13. Bikle D. D. 1,25(OH)2D3-regulated human keratinocyte proliferation and differentiation: basic studies and their clinical application. J Nutr. 1995 Jun;125(6 Suppl):1709S–1714S.
  14. Nast A., Gisondi P., Ormerod A. D., Saiag P., Smith C., Spuls P. I. et al. European S3-Guidelines on the systemic treatmen of psoriasis vulgaris. Update 2015. Short version. EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2277–2294.
  15. American Academy of Dermatology Work Group, Menter A., Korman N. J., Elmets C. A., Feldman S. R., Gelfand J. M. et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137–174.
  16. Kogan N., Raimondo N., Gusis S. E., Izcovich A., Abarca Duran J. A., Barahona-Torres L. et al. Latin American Clinical Practice Guidelines on the Systemic Treatment of Psoriasis SOLAPSO — Sociedad Latinoamericana de Psoriasis (Latin American Psoriasis Society). Int J Dermatol. 2019 Aug;58(Suppl 1):4–28.
  17. van de Kerkhof P. C., Cambazard F., Hutchinson P. E., Haneke E., Wong E., Souteyrand P. et al. The effect of addition of calcipotriol ointment (50 micrograms/g) to acitretin therapy in psoriasis. Br J Dermatol. 1998 Jan;138(1):84–89.
  18. Grossman R. M., Thivolet J., Claudy A., Souteyrand P., Guilhou J. J., Thomas P. et al. A novel therapeutic approach to psoriasis with combination calcipotriol ointment and very low-dose cyclosporine: results of a multicenter placebo-controlled study. J Am Acad Dermatol. 1994 Jul;31(1):68–74.
  19. Ramsay C. A., Schwartz B. E., Lowson D., Papp K., Bolduc A., Gilbert M. Calcipotriol cream combined with twice weekly broad-band UVB phototherapy: a safe, effective and UVB-sparing antipsoriatric combination treatment. The Canadian Calcipotriol and UVB Study Group. Dermatology. 2000;200(1):17–24.
  20. Frappaz A., Thivolet J. Calcipotriol in combination with PUVA: A randomized double-blind placebo study in severe psoriasis. Eur J Dermatol. 1993;3:351–354.
  21. Kragballe K., Austad J., Barnes L., Bibby A., de la Brassinne M., Cambazard F. et al. Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(4):319–326.
  22. Luger T. A., Cambazard F., Larsen F. G., Bourcier M., Gupta G., Clonier F. et al. A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis. Dermatology. 2008;217(4):321–328.
  23. Ortonne J. P., Ganslandt C., Tan J., Nordin P., Kragballe K., Segaert S. Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial. J Eur Acad Dermatol Venereol. 2009 Aug;23(8):919–926.

Copyright (c) 2019 Bakulev A.L., Petrunin D.D.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 60448 от 30.12.2014.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies