AIM: To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZ ASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis. METHODS: QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months. RESULTS: Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points. CONCLUSIONS: The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.
RCT Entities:
AIM: To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis. METHODS: QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months. RESULTS: Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points. CONCLUSIONS: The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.
Authors: Stephanie J Lax; Jane Harvey; Emma Axon; Laura Howells; Miriam Santer; Matthew J Ridd; Sandra Lawton; Sinéad Langan; Amanda Roberts; Amina Ahmed; Ingrid Muller; Long Chiau Ming; Saumya Panda; Pavel Chernyshov; Ben Carter; Hywel C Williams; Kim S Thomas; Joanne R Chalmers Journal: Cochrane Database Syst Rev Date: 2022-03-11
Authors: Thomas Luger; Mark Boguniewicz; Warner Carr; Michael Cork; Mette Deleuran; Lawrence Eichenfield; Philippe Eigenmann; Regina Fölster-Holst; Carlo Gelmetti; Harald Gollnick; Eckard Hamelmann; Adelaide A Hebert; Antonella Muraro; Arnold P Oranje; Amy S Paller; Carle Paul; Luis Puig; Johannes Ring; Elaine Siegfried; Jonathan M Spergel; Georg Stingl; Alain Taieb; Antonio Torrelo; Thomas Werfel; Ulrich Wahn Journal: Pediatr Allergy Immunol Date: 2015-04-13 Impact factor: 6.377
Authors: Alice Heaney; Jeanette Wilburn; Matthew Rouse; Shannon Langmead; Jaishri O Blakeley; Susan Huson; Stephen P McKenna Journal: Mol Genet Genomic Med Date: 2020-10-21 Impact factor: 2.183