PMID- 18782316 OWN - NLM STAT- MEDLINE DCOM- 20090206 LR - 20131121 IS - 1365-2133 (Electronic) IS - 0007-0963 (Linking) VI - 159 IP - 6 DP - 2008 Dec TI - Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. PG - 1322-30 LID - 10.1111/j.1365-2133.2008.08807.x [doi] AB - BACKGROUND: Rational health care decision-making based on outcomes and economic evidence is essential to provide the best possible care for individual patients with atopic dermatitis (AD). OBJECTIVES: To describe treatment outcomes and to evaluate resource utilization and associated cost of maintenance use of tacrolimus ointment (MU) vs. standard use of tacrolimus ointment (SU) in adults with AD. METHODS: A pan-European, phase III multicentre randomized clinical trial was conducted. Patients with mild to severe AD were randomized to tacrolimus 0.1% ointment (MU) or vehicle (SU) twice per week for 12 months. Disease exacerbations were treated by using open-label tacrolimus 0.1% ointment twice daily. Resource utilization data were collected prospectively alongside the clinical trial. Costs of pooled resource data were determined using German unit cost data. Direct and indirect costs were considered from third party payer, patient and societal perspectives. RESULTS: All patients with moderate and severe AD were included in a subanalysis, 75 patients in the MU arm (57% moderately affected) and 59 patients in the SU arm (59% moderately affected). In patients with moderate AD, the number of disease exacerbations in the MU arm was 2.4 vs. 5.5 in the SU arm (P<0.001); in patients with severe AD corresponding figures were 2.3 vs. 7.4 (P<0.001), respectively. Mean+/-SD total annual cost per patient was euro1525+/-1081 (MU) vs. euro1729+/-1209 (SU) in patients with moderate AD and euro2045+/-2013 (MU) vs. euro2904+/-1510 (SU) in patients with severe AD. CONCLUSIONS: Maintenance treatment with 0.1% tacrolimus ointment is more effective and leads to cost savings and improved health-related quality of life in comparison with standard use of 0.1% tacrolimus ointment, especially in patients with severe AD. FAU - Wollenberg, A AU - Wollenberg A AD - Klinik und Poliklinik fur Dermatologie und Allergologie, Ludwig-Maximilians Universitat, Munich, Germany. FAU - Sidhu, M K AU - Sidhu MK FAU - Odeyemi, I AU - Odeyemi I FAU - Dorsch, B AU - Dorsch B FAU - Koehne-Volland, R AU - Koehne-Volland R FAU - Schaff, M AU - Schaff M FAU - Ehlken, B AU - Ehlken B FAU - Berger, K AU - Berger K LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20080906 PL - England TA - Br J Dermatol JT - The British journal of dermatology JID - 0004041 RN - 0 (Immunosuppressive Agents) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Adult MH - Cost-Benefit Analysis MH - Dermatitis, Atopic/*drug therapy/economics MH - Drug Administration Schedule MH - Female MH - Health Care Costs MH - Health Status MH - Humans MH - Immunosuppressive Agents/*economics/therapeutic use MH - Male MH - Quality of Life MH - Tacrolimus/*economics/therapeutic use MH - Young Adult EDAT- 2008/09/11 09:00 MHDA- 2009/02/07 09:00 CRDT- 2008/09/11 09:00 PHST- 2008/09/11 09:00 [pubmed] PHST- 2009/02/07 09:00 [medline] PHST- 2008/09/11 09:00 [entrez] AID - BJD8807 [pii] AID - 10.1111/j.1365-2133.2008.08807.x [doi] PST - ppublish SO - Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.