Down-Titration of Infliximab:The Real-Life Use in Psoriatic Patients
December 2016 | Volume 15 | Issue 12 | Editorials | 1584 | Copyright © December 2016
Federico Bardazzi MD,a Camilla Loi MD,a Francesca Prignano MD,b Federica Ricceri MD,b Ferdinando Giordano PhD,c Annalisa Patrizi MD,a and Michela Magnano MDa
aDepartment of Specialized, Clinical and Experimental Medicine, Division of Dermatology, University of Bologna, Italy bDepartment of Medical-Surgical Critical Area, Section of Clinical, Preventive and Oncological Dermatology, University of Florence, Italy cDepartment of Physics, University of Catania and INFN, Italy
Recently, the down-titration of the anti-tumor necrosis factor (anti-TNF) agents has become common for the patients with a low disease activity, particularly in rheumatology. However, in dermatology, this practice has not been investigated, even if it is already used by several Psoriasis Centres in Italy. We reviewed the charts of patients treated with in iximab at two Italian Referral Psoriasis Centres. Our study considered a total of 32 patients, whose 20 received in iximab at longer intervals (10 weeks) and 12 at the standard intervals (8 weeks). The group who received the treatment every 10 weeks showed a higher percentage (25%) of relapses, while in the second group, only 2 patients had a worsening of psoriasis (17%). However, the P-value was 0.28, which cannot be considered statistically significant. Our results demonstrated that in iximab could be down-titrated without a significant increase risk
of relapses.The main advantage of this administration method may be the improving of the patient’s quality of life. So, for patients with a low disease activity, it may be suitable prolonging the dose intervals. Limitations of our study included the retrospective non- interventional nature and the absence of a control group with the same patient characteristics.J Drugs Dermatol. 2016;15(12):1584-1586.
The anti-tumor necrosis factor (anti-TNF) drugs have allowed a complete and rapid remission in patients with moderate to severe psoriasis, but these drugs are often associated to dose-dependent adverse effects and high costs.1 For this reason, the down-titration (dose reduction, discontinuation and disease activity guided dose tapering) of the available anti-TNF agents has become recently more and more common for the patients with a low disease activity, particularly in rheumatology.1 Although in dermatology this practice has not been investigated yet, it is already used by several Psoriasis Centres in Italy. Infliximab, one of the most used anti-TNF agents, is a monoclonal antibody that is administered intravenously at a dose of 5 mg/kg at the baseline, then after 2 and 6 weeks and nally every 8 weeks. Due to its administration methods, requiring a frequent hospitalization, infliximab may have a high impact on patient’s quality of life and important overall costs.1 Thus, the down-titration of infliximab, particularly prolonging the dose intervals (10 weeks instead of 8 weeks), has already been performed for several years in clinical practice. Therefore, we decided to perform a retrospective study, aiming to establish if the elongation of dose intervals is associated with a higher rate of psoriasis relapses and could be considered a valid treatment method. We reviewed the clinical charts of patients treated with infliximab at the outpatient services of two Italian referral Psoriasis Centres (Division of Dermatology, University of Bologna, Italy and Division of Preventive and Oncological Dermatology, University of Florence, Italy). We included in this retrospective observational study all the patients affected by moderate-severe psoriasis treated with infliximab since May 2005. We divided the patients in two different groups: a group represented by subjects with stable remission of psoriasis (Psoriasis Area and Severity Index score, PASI=0) for at least 12 months at the standard dose (5 mg/kg every 8 weeks), who then received the treatment at prolonged dose intervals (5 mg/kg ev- ery 10 weeks) and the other group including the patients who have reached an improvement of the 90% of their initial PASI (PASI90) and continued the standard administration intervals (5 mg/kg every 8 weeks). For each group, we considered the percentage of relapses, defining a relapse the worsening of the 50% of the initial PASI, along with the duration of the disease, the beginning of the therapy, the PASI before the beginning of the therapy and the main comorbidities (smoking habits, diabetes, psoriatic arthritis). We also calculated the total annual savings, based on the cost of infliximab in Italy at 5mg/kg for an average patient of 70 kg, with the prolonged interval administration. The statistical test between the two groups, as de ned above, was performed using the Welch’s t-test (that assumes unequal sample sizes as well as unequal variances). We therefore used a standard