Anti-interleukin-23 for psoriasis in elderly patients: guselkumab, risankizumab and tildrakizumab in real-world practice.

BACKGROUND: Elderly patients (aged ≥ 65 years) represent an increasing proportion of patients with psoriasis and 15% of these have moderate to severe disease. Biologics are being used frequently in this group of patients even though safety and efficacy data are limited. In addition, owing to anti-interleukin (IL)-23 therapies being a relatively recent option, no data have been reported about their use in elderly patients with psoriasis. AIM: To evaluate and compare the safety and efficacy of guselkumab, risankizumab and tildrakizumab in real-world practice in elderly patients. METHODS: This was a single-centre retrospective study that enrolled patients aged ≥ 65 years with moderate to severe plaque psoriasis, treated with guselkumab, risankizumab or tildrakizumab. The length of the study for each group depended on the drug (44 weeks for risankisumab, 40 weeks for guselkumab and 28 weeks for tildrakizumab, owing to its more recent availability in Italy). RESULTS: In total, 34 patients were enrolled (n = 20 on guselkumab; n = 8 on risankizumab; n = 6 on tildrakizumab). At Week 4, 29.4% reached 90% improvement in Psoriasis Area and Severity Index (PASI90) and 8.8% reached 100% improvement in PASI (PASI100); at Week 28, PASI90 and PASI100 was reached by 58.8% and 29.4%, respectively. At the final follow-up (Week 40 or 44, depending on drug), data were available only for the risankizumab (Week 40) and guselkumab (Week 44) and groups, and showed that 71.4% of patients had reached PASI90 and 53.5% had reached PASI100. Four patients (11.7%) discontinued treatment. No significant differences were found between the three groups. The limitations of the study included its retrospective nature of the study, small sample size, and different numbers of patients and follow-up duration for the different groups (highest for guselkumab, lowest for tildrakizumab). CONCLUSION: The three anti-IL-23 therapies assessed are promising, safe and effective options in elderly patients, and there was no significant difference between them. However, more data are needed to confirm our results and to understand their role in the management of this group of patients.

Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial.

BACKGROUND: Psoriasis contributes to unemployment, work impairment, missed workdays and substantial indirect costs due to lost productivity. Combination Cal/BD foam is the only topical that is approved for long-term maintenance treatment of plaque psoriasis for 52 weeks. This is the first known investigation of the effect of topical psoriasis therapy on productivity. OBJECTIVE: To examine the change in work productivity and activity impairment after 4 weeks of treatment with fixed-dose combination calcipotriol 50 µg/g/betamethasone dipropionate 0.5 mg/g (Cal/BD) foam and observe long-term changes after 52 weeks of long-term management (proactive or reactive treatment). METHODS: This is a post-hoc analysis of the PSO-LONG trial - a phase 3, randomized, double-blind, vehicle-controlled, parallel group, international multi-centre trial of treatment with combination Cal/BD foam. Work and activity impairment due to psoriasis were assessed by the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment Psoriasis (WPAI:PSO) questionnaire at baseline, week 4, week 28 and week 56. The improvement in hours of work productivity was translated into monthly and annual indirect cost savings estimates for patients in Italy, Sweden, United Kingdom, Canada and Germany. RESULTS: Using fixed-dose combination Cal/BD foam for four weeks significantly reduced psoriasis-related work presenteeism, total work productivity impairment (TWPI) and total activity impairment (TAI) over 56 weeks, with significant improvements observed as early as 4 weeks after the baseline visit. The proportion of patients reporting impact on work productivity (as measured by presenteeism and TWPI) and activity impairment (as measured by both DLQI-Q7b and TAI) also decreased. CONCLUSION: Fixed-dose combination Cal/BD foam used for long-term management of psoriasis significantly reduces psoriasis-related work productivity and activity impairment which may result in substantial indirect cost savings. Clinical Trial Registration NCT02899962, EudraCT number: 2016-000556-95.

Impact of Covid-19 pandemic on injection-based practice: report from an Italian multicenter and multidisciplinary survey.

Background: There are no papers exploring the impact of COVID-19 pandemic on the injection-based practice in patients affected by different rheumatic diseases, including osteoarthritis. The aim was to investigate the impact of COVID-19 pandemic on injection-based practice trough the Italian country. Study design: A survey-based retrospective cross-sectional study. Methods: An Italian-language questionnaire was developed by a group of senior researchers and distributed by e-mail to some Rheumatology, Orthopedic and Rehabilitation Units from different geographic areas of Italy. The survey included information about the number of injections performed during COVID-19 pandemic (stratified by injected agents and injected joint), in comparison to the pre-pandemic period, and the possible reasons behind an eventual reduction. Responses were collected and descriptive analysis calculated. Results: Eleven centers of the National Health Service completed the survey. The activities of the injections services significantly decreased across the country with a percentage of reduction of 60% compared to the pre-pandemic period. A significant reduction of both intra-articular and peri-articular injections was registered. Among intra-articular. treatments, the most affected ones were the hyaluronic acid injections, when compared to corticosteroids. A significant decrease of the total amount of peri-articular injections was observed. The strict government restrictions and the fear of patients to become infected represented the most limiting factors. Conclusions: The reported decrease of the injection-based practice in our country during the COVID-19 pandemic highlights the detrimental effects of the COVID-19 pandemic on the management of chronic musculoskeletal diseases with possible negative consequences in terms of disability and quality of life.

Real-life efficacy and safety of secukinumab in elderly patients with psoriasis over a 2-year period.

BACKGROUND: The prevalence of psoriasis is increasing among older people. Elderly patients with psoriasis represent a challenge for dermatologists owing to multiple comorbidities, polypharmacy and immune senescence, which lead to an increased possibility of adverse events (AEs), drug interactions and susceptibility to cancers and infections. Therefore, conventional systemic therapies are often contraindicated, with biologics appearing as the mainstay for moderate-to-severe disease. However, the data on efficacy and safety of biologics in older people are scant. AIM: To evaluate the efficacy and safety of secukinumab in elderly patients with psoriasis over a 2-year period. METHODS: A real-life retrospective observational study was performed on patients aged ≥ 65 years with moderate-to-severe plaque psoriasis who were treated with secukinumab at the Psoriasis Care Unit of the University of Naples Federico II, Italy from June 2016 to June 2019. RESULTS: Mean Psoriasis Area Severity Index (PASI) reduced from 11.4 ± 6.3 at baseline to 2.1 ± 1.7 at week 24 and 1.7 ± 1.9 at week 96 (P < 0.001 for all follow-up visits), with a final mean PASI reduction of 85.1%. A similar trend was noted for body surface area (BSA), with baseline value of 27.5 ± 15.7 decreasing to 6.8 ± 5.0 at week 24, and to 3.3 ± 2.5 at week 96 (P < 0.001 at all follow-up visits), with a final mean BSA score reduction of 88.0%. Registered AEs did not lead to secukinumab discontinuation, except in one patient (3.4%). CONCLUSION: Secukinumab seems to be a safe and effective treatment for elderly patients with psoriasis, who frequently have multiple comorbidities, polypharmacy and multiple failures with previous systemic treatments including biologics.

Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real-world multicentre Italian study.

BACKGROUND: Certolizumab, a pegylated tumour necrosis factor-α inhibitor, reduced disease activity in randomized trials of patients with psoriasis and psoriatic arthritis. Real-life data are missing. OBJECTIVE: To confirm the effectiveness and safety of certolizumab in patients with psoriasis and psoriatic arthritis in routine clinical practice. METHODS: In this retrospective study involving 11 Italian sites, patients with psoriasis and psoriatic arthritis received subcutaneous certolizumab (400 mg loading dose at 0, 2 and 4 weeks, followed by 200 mg every 2 weeks) for up to 52 weeks. Primary outcomes included mean change from baseline in Psoriasis Area and Severity Index (PASI) and modified Nail Psoriasis Severity Index (mNAPSI) scores, and the proportion of patients achieving a 75%, 90% or 100% reduction in PASI score. Other endpoints included Disease Activity Score computed on 44 joints correlated with the erythrocyte sedimentation rate during the first hour (DAS44-ESR), Tender Joint Count (TJC), Swollen Joint Count (SJC), pain [visual analogue scale (VAS) score], inflammatory markers and quality of life (QOL). RESULTS: In the study were enrolled 153 patients (mean age: 55 years). Certolizumab reduced the mean PASI score from baseline by 4.45, 6.30 and 7.58 at weeks 12, 24 and 52, respectively (P < 0.001 for all). At weeks 24 and 52, 69.6% and 83.3% of patients had a PASI score ≤3. DAS44-ESR, TJC, SJC and mNAPSI scores, and pain VAS were also all significantly improved from baseline at each time point. C-reactive protein levels decreased during treatment, being significant at week 24. On multivariate analysis, psoriasis duration, baseline PASI, mNAPSI and pain VAS scores were found to be predictive of the improvement in PASI score at week 12. CONCLUSION: Certolizumab displayed also in the real-life encouraging results in both psoriasis and psoriatic arthritis patients.

Age and gender influence on HIDRAdisk outcomes in adalimumab-treated hidradenitis suppurativa patients.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic relapsing inflammatory skin disease characterized by a significant impairment of patients' quality of life (QoL). It has been recently found that clinical severity of HS does not correlate well with QoL. Therefore, it is important to enhance the evaluation of severity considering the disease burden on QoL. Recently, a new graphical tool able to better describe HS burden, the so-called HIDRAdisk, has been introduced. OBJECTIVE: To investigate the utility of HIDRAdisk in clinical practice before and after treatment and to analyse whether specific factors such as age and gender may influence the outcomes in patients with moderate-to-severe HS. METHODS: A single-centre retrospective study on 24 patients (13F/11M, mean age 38 ± 15 years) with moderate-to-severe HS was performed. Clinical data (disease severity and quality of life) were collected at baseline and after 12 weeks of adalimumab. RESULTS: HIDRAdisk showed significantly better improvements in males (69.8 ± 6.2-49.6 ± 10.8) compared to females (80.7 ± 6.0-72.3 ± 6.7), P <0.001. A significant correlation was found in the total population between HS severity values measured through the modified Sartorius score (mSS) and QoL measured through HIDRAdisk. As regards the relationship between disease outcomes and age, a trend for better HIDRAdisk outcomes in younger patients (<40 years) compared to older ones was observed. CONCLUSIONS: HIDRAdisk appears as a complete and informative tool which can easily measure the global burden of HS, guiding treatment choice and evaluating its efficacy.

Psoriasis and skin pain: real-life effectiveness of calcipotriol plus betamethasone dipropionate in aerosol foam formulation.

BACKGROUND/OBJECTIVE: Although 40% of psoriasis patients reported skin pain, this symptom is often underestimated. A new formula of calcipotriol plus betamethasone dipropionate (Cal/BD) has been recently approved for psoriasis treatment. Therefore, we aimed to evaluate the efficacy of Cal/BD aerosol foam on skin pain of patients with plaque psoriasis. METHODS: A real-life 4-week prospective, open study on Cal/BD aerosol foam (not compared to vehicle or emollient cream) was performed in adult psoriasis patients attending three Dermatology units located in Campania region, Italy, between March and October 2018. Inclusion criteria were a history of skin pain over the last week and psoriatic involvement of the palmar area. Before (t0) and after a course of once daily application of Cal/BD aerosol foam for 4 weeks (t1), the following items were evaluated: Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) index of target plaque on palmar region, subjective skin pain features through Pain Qualities Assessment Scale questionnaire and skin pain threshold measured by pressure digital algometer at palmar psoriatic plaques. RESULTS: Seventy-five patients (43 male, mean age of 43.2 years) were enrolled. After 4 weeks of therapy with Cal/BD aerosol foam, a significant improvement in both PASI (mean: 6.5 ± 2.1 at t0 vs. 2.3 ± 1.6 at t1) and palmar plaques PGA (mean: 3.6 at t0 vs. 1.7 at t1) was observed (P < 0.001). The mean intensity score of skin pain decreased from 7.6 to 1.3 (P < 0.001); among skin pain qualities, intense, sensible, aching and unpleasant showed the highest rate of reduction (t0-t1: 6.3, 6.3, 6.1 and 5.8, respectively). Pain threshold of palmar skin lesions increased at t1. CONCLUSIONS: Our real-life study suggested that Cal/BD aerosol foam may represent a valid topical anti-psoriatic treatment, not only improving skin lesions, but also relieving cutaneous pain, thus contributing to ameliorate patients' quality of life.

The effect of smartphone addiction on hand joints in psoriatic patients: an ultrasound-based study.

BACKGROUND: Distal interphalangeal (DIP) arthritis is a frequent form of psoriatic arthritis being often linked to nail psoriasis. Modern society is characterized by overuse of smartphones. Indeed, literature has recently focalized on research into smartphone addiction and health-related problems. OBJECTIVES: As smartphone addiction is able to determine overuse and repeated movements of DIP joints and nails, the aim of this study was to evaluate the impact of smartphone use on hand joints of young psoriatic patients. METHODS: An observational study involving four different groups such as non-smartphone-addicted (SA) psoriatic patients, SA psoriatic patients, non-SA controls and SA controls was performed. Each subject underwent an ultrasound examination of both hands by three independent and blinded to group assignment radiologists. A specific score was used to evaluate the inflammatory state of the analysed joints. RESULTS: The total ultrasound score was statistically significantly higher in SA controls respect to non-SA controls (3.4 vs. 1.4; P < 0.05) as well as in SA psoriasis patients compared to non-SA psoriatic subjects (15.2 vs. 6.7; P < 0.01). Higher mean of ultrasound score was found for left hand in controls (both SA or not) and for right hand in psoriatic subjects (both SA or not), however without reaching statistical significance. CONCLUSIONS: Smartphone overuse was found to be linked with higher signs of inflammation of musculoskeletal structures of hands joints in both psoriasis and controls through ultrasound examination. Therefore, smartphone overuse may be a factor which facilitate or speed up the possible development of psoriatic arthritis.