Regular support provided by dermatological nurses improves outcomes in patients with psoriasis treated with topical drugs: a randomized controlled trial

Abstract

Background: Patient adherence to topical antipsoriatic drugs is often poor, leading to poor efficacy. Use of long-term support delivered by dermatological nurses to patients treated with topical drugs may improve outcome.

Aim: To evaluate whether regular support from dermatological nurses improves outcome and treatment adherence in patients with psoriasis receiving topical medications.

Methods: We conducted a randomized controlled trial (RCT) (clinicaltrials.gov registration NCT04220554), in which patients received once-daily topical medications (containing corticosteroids and/or calcipotriol) for as long as their psoriasis was visible. The patients were randomly allocated to standard care by the dermatologist either with (n = 51) or without (n = 52) support from dermatological nurses. The nurse support intervention consisted of a structured dermatological consultation at baseline and Week 1, followed by contact with a nurse each month (in the outpatient clinic or by telephone). The primary outcome was severity of psoriasis, which was measured by the Lattice System Physician's Global Assessment (LS-PGA) and assessed by intention-to-treat analyses using linear mixed regression models for longitudinal data. Secondary outcomes were quality of life (measured by the Dermatology Life Quality Index; DLQI) and good adherence (defined as use of ≥ 80% of recommended doses).

Results: In total, 92 patients (89%) completed the 48-week trial period. The intervention group improved more than the nonintervention group from baseline to Week 24 in LS-PGA (2.21 vs. 1.28, P = 0.001) and in DLQI at Week 12 (6.50 vs. 1.55, P < 0.001). Differences between the two groups in favour of the intervention were observed throughout the study period. More participants in the intervention group had good adherence compared with the nonintervention group (36% vs. 14%, P < 0.001).

Conclusion: Regular, continued patient support from dermatological nurses increased the efficacy of psoriasis treatment, improved quality of life and enhanced long-term adherence to topical antipsoriatic drugs. However, there is still room for more improvement.

Conflict of interest statement

MTS and KEA received a grant from the LEO Foundation to conduct the trial. SRF is a speaker for Janssen and Taro; a consultant and speaker for Galderma, Stiefel/GlaxoSmithKline, Abbott Labs, LEO Pharma Inc.; has received grants from Galderma, Janssen, Abbott Labs, Amgen, Stiefel/GlaxoSmithKline, Celgene and Anacor; is a consultant for Amgen, Baxter, Caremark, Gerson Lehrman Group, Guidepoint Global, Hanall Pharmaceutical Co. Ltd, Kikaku, Lilly, Merck & Co. Inc., Merz Pharmaceuticals, Mylan, Novartis Pharmaceuticals, Pfizer Inc. Qurient, Suncare Research and Xenoport; is on an advisory board for Pfizer Inc.; is the founder of and holds stocks in Causa Research and holds stocks in Sensal Health; and receives royalties from UpToDate and Xlibris. The other authors declare that they have no conflict of interest.

© 2022 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Figures

Figure 1

(a–c) Participant flowchart, showing treatment adherence measured by (a) first‐filled prescriptions; (b) weight of consumed medication (calculated by weighing medication at start and end of treatment period; and (c) by patient self‐report on a study‐specific scale. DLQI, Dermatology Life Quality Index; EQ‐5D, European Quality of life 5 Dimensions; LS‐PGA, Lattice System Physician's Global Assessment.

Figure 2

Box plot of Lattice System Physician's Global Assessment (LS‐PGA) measurements. At baseline visit, patients in the nonintervention group had less affected LS‐PGA compared with the intervention group. During treatment with topical corticosteroid‐containing preparations, LS‐PGA decreased for both the nonintervention and intervention groups from baseline to weeks 12, 24, 36 and 48. *Significant differences in favour of the intervention were noted between the nonintervention and intervention groups at weeks 24 (1.28 vs. 2.21, P < 0.001), 36 (1.68 vs. 2.54, P < 0.01) and 48 (1.68 vs. 2.69, P < 0.01). The mean is marked by a + sign. A horizontal line inside the box marks the median values, but as the median in the intervention group at week 36 and in the nonintervention group at week 48 are both equal to the first quartile/lower border of the box, it is not distinguishable as a separate line in those cases. Dots represent outliers.

Figure 3

Effects of nurse consultation, telephone visits and specific nurse on psoriasis outcomes. Coefficients (Spearman ρ with 95% CI from multivariate analysis show the associations between dichotomized data of 10% lower attendance to the dermatological nurse consultations, 10% more use of telephone visits, and different dermatological nurses (nurses 1, 2 or 3) and continuous changes in Lattice System Physician's Global Assessment (LS‐PGA) measurements. Most factors showed nonsignificant associations (i.e. coefficients around 0); however, nurse 2 achieved a greater reduction in LS‐PGA than the other two nurses.

Figure 4

Box plots of Dermatology Life Quality Index (DLQI) measurements. At baseline visit, patients in the nonintervention group reported less affected DLQI compared with the intervention group. During treatment with topical corticosteroid‐containing drugs, DLQI decreased for the nonintervention from baseline to Week 12, then slightly increased at Week 24 and thereafter continued to drop at Weeks 36 and 48. In the intervention group, DLQI dropped from baseline to Weeks 12, 24 and 36, but thereafter slightly increased at Week 48. *Significant improvements in favour of the intervention were noted between the nonintervention and intervention group at Weeks 12 (1.55 vs. 6.50, P < 0.001), 24 (1.12 vs. 7.37, P < 0.001), 36 (1.42 vs. 7.36, P < 0.001) and 48 (2.31 vs. 7.93, P < 0.001). The mean is marked by a + sign. A horizontal line inside the box marks the median values, but as the median in the intervention group at Week 36 and in the nonintervention group at Week 48 are both equal to the first quartile/lower border of the box, it is not distinguishable as a separate line in those cases. Dots represent outliers.