Efficacy and safety of methantheline bromide (Vagantin®) in axillary and palmar hyperhidrosis: results from a multicenter,randomized, placebo‐controlled trial

Background Focal hyperhidrosis can severely affect quality of life. So far, knowledge on the effect of systemic therapy of focal hyperhidrosis is limited. Objective To assess the efficacy and safety of methantheline bromide (MB) in the treatment of axillary and palmar‐axillary hyperhidrosis. Methods A multicenter controlled randomized double‐blind clinical trial was conducted in patients with axillary or palmar‐axillary hyperhidrosis defined by a sweat production >50 mg/5 min. Patients received 3 × 50 mg MB daily or placebo over a period of 28 ± 1 days. Main outcome criterion was the reduction of sweat as measured by gravimetry on day 28 ± 1. Quality of life was assessed by Dermatology Life Quality Index (DLQI) and Hyperhidrosis Disease Severity Score (HDSS). Results A total of 339 patients were randomly assigned to receive MB or placebo. On day 28 ± 1, the mean axillary sweat production was 99 mg for MB and 130 mg for placebo compared with 168 mg and 161 mg respectively at baseline (P = 0.004). Patient′s HDSS score decreased in the MB group from 3.2 to 2.4 compared with 3.2 to 2.7 for placebo (P = 0.002). Similar results could be obtained for the DLQI with 9.7 for MB and 12.2 for placebo, which decreased from 16.4 or 17 respectively (P = 0.003). Tolerability was good for both groups. The most frequent adverse event was dry mouth. Conclusion Fifty milligrams methantheline bromide three times a day is an effective and safe treatment of axillary hyperhidrosis.     

A novel multidisciplinary educational programme for patients with chronic skin diseases: Ghent pilot project and first results

Chronic inflammatory skin disorders have a major impact on the patients’ health related quality of life. Preliminary studies to date have suggested that additional educational and psychological training programmes may be effective in the management of chronic skin diseases, although more rigid methodology is needed. Our purpose was to investigate the effect on quality of life of a novel multidisciplinary educational programme for patients, 18 years or older, with chronic skin diseases. The 12-week intervention encompasses cognitive education on skin and general health issues, and stress-reducing techniques. Quality of life questionnaires were used to assess the participants at baseline and at the end of the program. These comprehend Dermatology Life Quality Index (DLQI), Skindex-29, Psoriasis Disability Index (PDI) and Quality of Life Index for Atopic Dermatitis (QoLIAD). Fifty-five patients participated in six programmes since 2006. Forty-three patients completed the programme. Overall, compared to baseline, DLQI (n = 39) improved by 5.64 points (p < 0.001; SD ±6.09), Skindex-29 (n = 27) by 19.67 points (p < 0.001; SD ±17.37), PDI (n = 9) improved by 7.44 points (p = 0.019; SD ±7.60) and QoLIAD (n = 13) improved by 4.39 points (p = 0.036; SD ±6.69) by the end of the intervention. Preliminary results show that the quality of life of the patients with chronic skin diseases improved significantly after participation to the programme. These positive initial results are stimulating to set up a prospective controlled randomised trial investigating the impact on quality of life, the clinical efficacy and the cost-effectiveness of this educational intervention programme.     

Oxybutynin gel versus nanoemulgel for treating primary palmar hyperhidrosis: A pilot double-blind randomized controlled trial

Introduction

Palmar hyperhidrosis or excessive palmar sweating can reduce one's quality of life as it is associated with significant physical and occupational disabilities. We compared the gel and nanoemulgel of oxybutynin in treating these patients.

Materials and Methods

This pilot study was performed as a double-blind controlled randomized clinical trial at Shahid Faghihi Hospital, Shiraz, Iran. In two randomly allocated groups of 15, patients diagnosed with primary palmar hyperhidrosis by an attending dermatologist applied half a fingertip (roughly 0.25 g) of 1% oxybutynin topical gel or 1% oxybutynin nanoemulgel to both palms every 12 h for one month. The Hyperhidrosis Disease Severity Scale (HDSS), Visual Analog Scale (VAS), and Dermatology Life Quality Index (DLQI) were used to assess the patients at the beginning and end of the study. Statistical analysis was performed using SPSS version 25.

Results

The groups were similar in terms of age (p = 0.800), sex (p = 0.096), and baseline HDSS, VAS, and DLQI scores. The mean HDSS scores decreased significantly (p = 0.001) over time in patients receiving the gel (3.00 ± 1.00 vs. 2.33 ± 0.61) or nanoemulgel (2.92 ± 0.82 vs. 2.14 ± 0.53), without a significant difference between the groups. The same was true for the VAS and DLQI scores. Three patients in each group experienced transient, self-limited anticholinergic side effects (p = 0.983).

Conclusion

Oxybutynin gel and nanoemulgel offer equal safety and similar efficacy in reducing the disease severity and increasing the quality of life of patients with palmar hyperhidrosis.     

Botulinum toxin in the treatment of sweat‐worsened foot problems in patients with epidermolysis bullosa simplex and pachyonychia congenita

Background Painful foot blistering is a common problem in patients with epidermolysis bullosa simplex (EBS) and pachyonychia congenita (PC). Hyperhidrosis, a condition which can be effectively blocked by plantar injections of botulinum toxin (Btx), often exacerbates the blistering. Objectives A retrospective evaluation of the effects of Btx injections in 14 patients with EBS and PC with foot blisters and painful callosities. Methods After informed consent, patients with EBS (n = 6) and PC (n = 8), aged 7–66 years, who had received Btx therapy at our centre since 2003, were included. The treatment consisted of multiple plantar injections of Btx A or Btx B after prior regional or general anaesthesia. Patients were interviewed about the treatment effect and were asked to score the improvement from 0 to 5, where 5 is ‘excellent’. One patient with PC with painful callosities was studied by magnetic resonance (MR) spectroscopic microimaging before and after Btx injections to disclose any underlying blisters. Results In total, 76 treatments were evaluated (one to 19 sessions per patient). Thirteen patients (93%) reported reduced plantar blistering and pain; the improvement score was ≥ 4 in four of six patients with EBS and six of eight patients with PC. The mean effect duration was 3 months. No adverse events, apart from mild anticholinergic side‐effects in two patients, were noted. MR spectroscopic microimaging showed disappearance of intraepidermal blistering after Btx therapy. Conclusions Plantar injection of Btx is an efficient, long‐lasting and safe treatment of painful blistering and callosities in EBS and PC that can be given repeatedly without loss of efficacy.     

Quality of life in adults with chronic idiopathic urticaria receiving desloratadine: a randomized, double-blind, multicentre, placebo-controlled study

Objective To assess the effect of desloratadine on quality of life (QoL) in chronic idiopathic urticaria (CIU). Study population Patients with a history of CIU (pruritus and weals lasting = 6 weeks) were included in this multicentre, randomized, double‐blind placebo‐controlled study that took place in dermatology centres throughout France. During the study, patients were randomized to receive desloratadine 5 mg daily or placebo for 42 days. Main outcome measures Variation of the scores of two QoL dermatology‐specific tools between baseline and day 42, the French translation version of the Dermatology Life Quality Index (DLQI) and the VQ‐Dermato (a French‐language scoring instrument). Results The intent‐to‐treat population comprised 137 patients [desloratadine (n = 65) or placebo (n = 72)]. Desloratadine treatment was associated with significantly greater improvements from baseline to day 42 compared with placebo in DLQI overall score (–6 vs. –2.2 points; P < 0.002) and VQ‐Dermato score (18.5 vs. 29.1 points; P = 0.009). Mean scores for sleep disruption and disruption of daily activities were significantly lower in the desloratadine group than in the placebo group from day 1 to the end of the study. Conclusions Desloratadine 5 mg/day was associated with significant improvements in two separate dermatology‐specific measures of QoL in patients with CIU. QoL proved to be a relevant primary outcome measure for therapeutic trials in CIU.     

Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial

Background PHOENIX 1 was a phase III, randomized, double‐blind, placebo‐controlled study that demonstrated the long‐term efficacy and safety of ustekinumab in patients with moderate‐to‐severe psoriasis. Objectives To assess the effect of ustekinumab maintenance therapy on health‐related quality of life (HRQoL) in PHOENIX 1 patients. Patients and methods Patients (n = 766) were randomized to receive ustekinumab 45 mg (n = 255) or 90 mg (n = 256) at weeks 0 and 4 and every 12 weeks thereafter, or placebo (n = 255) at weeks 0 and 4 with crossover to ustekinumab at week 12. Ustekinumab‐randomized patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI) 75 at weeks 28 and 40 were re‐randomized at week 40 to continue ustekinumab or be withdrawn until loss of therapeutic effect. HRQoL was assessed using the SF‐36 and Dermatology Life Quality Index (DLQI). Results At baseline, more than 97% had a DLQI > 1 and the average DLQI was > 10, indicating a significant impact on patients’ HRQoL. Significantly greater proportions of patients receiving ustekinumab 45 and 90 mg achieved a normalized DLQI score (≤ 1) compared with placebo (53·2%, 52·4% and 6·0%, respectively, both P < 0·001) at week 12 and achieved a clinically meaningful improvement (increase of at least five points) in SF‐36 physical (23·1%, 33·7% and 15·6%) and mental (25·5%, 31·3% and 14·8%) component summary scores. At week 12, changes in individual DLQI and SF‐36 domains were significantly better in each ustekinumab group vs. placebo (P < 0·001). The magnitude of improvement across SF‐36 scales was greatest for the bodily pain and social functioning domains. Improvements in HRQoL were sustained with maintenance ustekinumab therapy through at least 1 year. Regression analysis showed that, after adjustment for improvement in PASI or Physician’s Global Assessment (PGA), ustekinumab‐treated patients demonstrated significant improvements in DLQI. Conclusions Ustekinumab improves HRQoL in patients with moderate‐to‐severe psoriasis. Patient‐reported outcomes measured a treatment effect beyond that indicated by clinical measures.     

Consistent responses with guselkumab treatment in Asian and non‐Asian patients with psoriasis: An analysis from VOYAGE 1 and VOYAGE 2

Guselkumab, an interleukin‐23 blocker, was superior to placebo and adalimumab and well‐tolerated in phase 3 psoriasis studies (VOYAGE 1 and VOYAGE 2). This analysis evaluated the consistency of response in the Asian subpopulation in VOYAGE 1 and VOYAGE 2. Study designs were identical through week 24; patients were randomized to guselkumab, placebo, or adalimumab. Investigator's Global Assessment (IGA), Psoriasis Area and Severity Index (PASI), safety, and pharmacokinetic and immunogenicity data from VOYAGE 1 and VOYAGE 2 were pooled and compared by race (Asian, n = 199; non‐Asian, n = 1630). At week 16, treatment differences between guselkumab and placebo were 78.2 (95% confidence interval [CI], 66.9–89.6) and 76.4 (95% CI, 72.7–80.2) percentage points for IGA 0/1 (score of 0 or 1) and 70.1 (95% CI, 60.0–80.1) and 68.5 (95% CI, 64.9–72.2) percentage points for PASI 90 (≥90% improvement) in the Asian and non‐Asian populations, respectively. Treatment differences between guselkumab and adalimumab were 31.1 (95% CI, 17.7–44.6) and 16.1 (95% CI, 11.2–21.0) percentage points for IGA 0/1 and 24.9 (95% CI, 9.4–40.5) and 23.2 (95% CI, 17.7–28.6) percentage points for PASI 90 in the Asian and non‐Asian populations, respectively. Similar results were observed at week 24. Safety was generally similar between populations and among treatment groups. Median serum guselkumab concentrations over time were comparable between the populations. Comparable responses between the Asian and non‐Asian populations in this analysis suggest that the overall efficacy, safety, and the resulting benefit/risk analyses from VOYAGE 1 and VOYAGE 2 are applicable to Asian populations.     

Impact of ustekinumab on health‐related quality of life and sexual difficulties associated with psoriasis: results from two phase III clinical trials

Background Ustekinumab, a human anti‐interleukin‐12/23 monoclonal antibody, has been shown to effectively treat moderate‐to‐severe psoriasis which significantly affects health‐related quality of life (HRQoL), including patients’ sexual lives. Objectives The aim of this study was to determine if sexual difficulties associated with psoriasis are related to disease severity and whether sexual difficulties improve with skin disease during ustekinumab treatment. Methods  In phase III PHOENIX 1 and 2 trials, psoriasis patients were randomized to ustekinumab (n = 1334) at weeks 0 and 4 and q12 weeks thereafter or placebo (n = 662) at weeks 0 and 4 with crossover to ustekinumab at week 12. Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were used to assess psoriasis severity and patient‐reported HRQoL respectively. Based on DLQI Question #9, impaired sexual function was defined as ‘very much’ or ‘a lot’ of sexual difficulties. Results At baseline, mean DLQI was 12.0, indicating a very large negative effect on patients’ lives. Impaired sexual function was reported by 22.6% (women = 27.1%; men = 20.8%) and was significantly associated with increased psoriasis severity. At week 12, ustekinumab‐treated patients had a greater mean improvement in DLQI (?9.13 vs. ?0.53 with placebo, P < 0.001) and the proportion of patients with impaired sexual function decreased from 22.4% to 2.7% compared with no change with placebo (P < 0.001). Patients with greater PASI improvement experienced a greater reduction of sexual difficulties due to psoriasis. A similar pattern of improved sexual function was observed at weeks 24–28 in placebo crossover patients. Conclusions Ustekinumab treatment is associated with significant improvement in HRQoL and sexual difficulties due to psoriasis.     

Long‐Term Efficacy of Oxybutynin for Palmar and Plantar Hyperhidrosis in Children Younger than 14 Years

Oxybutynin for treating hyperhidrosis in children has been evaluated only in short‐term studies. We aimed to investigate the long‐term effects of oxybutynin in treating children with palmar and plantar hyperhidrosis who had not undergone surgery and who were monitored for at least 6 months (median 19.6 mos). A cohort of 97 patients was evaluated retrospectively, with particular attention to 59 children (ages 4–14 yrs) who were treated for longer than 6 months. Their quality of life (QOL) was evaluated using a validated clinical questionnaire before and after 6 weeks of pharmacologic therapy. A self‐assessment of hyperhidrosis was performed after 6 weeks and after the last consultation. By their final office visit, more than 91% of the children with hyperhidrosis treated with oxybutynin experienced moderate or great improvement in their level of sweating and 94.9% experienced improvement in QOL. More than 90% of children reported improvement of hyperhidrosis at other sites. Dry mouth was the most common side effect. Oxybutynin appears to be an effective treatment option for children with hyperhidrosis, and positive results are maintained over the long term (median 19.6 mos).     

Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial

Background Psoriasis is a chronic disease that significantly diminishes the health‐related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor α monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis. Objectives The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis. Methods In this double‐blind, placebo‐controlled trial, 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg^?1 of infliximab or placebo and were treated at weeks 0, 2 and 6. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. Results Infliximab induction therapy resulted in a substantial improvement in HRQOL. At week 10, patients in the infliximab 3‐ and 5‐mg kg^?1 groups showed a median percentage improvement in DLQI scores of 84·0% and 91·0%, respectively, compared with 0% in the placebo group (P < 0·001). The median decrease from baseline in DLQI score at week 10 was 8·0 and 10·0 for the 3 and 5 mg kg^?1 infliximab groups, respectively, compared with 0 in the placebo group (P < 0·001). Thirty‐three per cent and 40% of patients in the 3 and 5 mg kg^?1 infliximab groups, respectively, had a DLQI score of 0 at week 10, compared with 2% in the placebo group (P < 0·001). There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index (PASI) scores and the percentage change in DLQI scores during the same period (Spearman's correlation, 0·61, P < 0·001). When the infliximab and placebo treatment groups were combined, patients with at least 75% improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores (81%) than those with 50–75% improvement in PASI during the same period (60%). Conclusions Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis.     

The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque‐type psoriasis: a single‐blinded randomized controlled trial

Recently, thiazolidinediones have shown to be efficacious with a favorable safety profile when used in the treatment of chronic plaque‐type psoriasis. The aim of this study was to evaluate and compare the efficacy and safety of a combination of methotrexate plus pioglitazone and methotrexate alone in plaque‐type psoriasis. A total of 44 adult patients with plaque‐type psoriasis were included in the study. Patients were randomized to treatment with methotrexate alone (group A) or methotrexate plus pioglitazone (group B) for 16 weeks. The primary efficacy outcome measure was psoriasis area and severity index (PASI) score change between the study groups at week 16 relative to baseline. The secondary efficacy outcome measure was dermatology life quality index (DLQI) score change between the two groups at week 16 relative to baseline. The PASI 75 score was also measured. After 16 weeks of therapy, the percentage of reduction in the mean PASI score was 70.3% in group B and 60.2% in group A. PASI 75 was achieved in 14 patients (63.6%) in group B compared with two patients (9.1%) in group A within 16 weeks, which was significant (P < 0.001). At 16 weeks from the baseline, a 63.6% decrease in the mean DLQI score of group B was seen, while the decrease for group A was 56.9%. Pioglitazone enhances the therapeutic effect of methotrexate in plaque‐type psoriasis, as demonstrated by a reduction in the mean PASI scores. In terms of DLQI, there was no extra benefit by the addition of pioglitazone to methotrexate therapy.     

Trends in the prognosis of metastatic melanoma in the era of targeted therapy and immunotherapy: A single‐institution survey in Japan

Advances in anticancer therapy, including the development of targeted therapy and immunotherapy, have drastically changed treatment options for metastatic melanoma. However, to date, only a few studies have been published that directly compare overall survival (OS) before and after introduction of these new therapeutic options in Japan. We retrospectively surveyed patients with metastatic melanoma treated in our hospital between 1989 and 2019 to investigate the OS benefit of the new therapies. A total of 115 patients with metastatic melanoma (cutaneous origin, 92; mucosal, 14; uveal, two) were included in the study. Kaplan–Meier analysis showed that the patient group receiving targeted therapy/immunotherapy (TT/IT) (n = 47) had a median OS of 19.0 months, which was longer than that in patients receiving conventional chemotherapy (n = 42, 8.0 months) or no treatment (n = 26, 6.0 months) (P < 0.001). In the subgroup analysis performed for the TT/IT group, patients of younger age and with the BRAF mutation had significantly improved OS. As the number of treatment lines increased, the median OS tended to become longer. Our real‐world data confirmed an improvement of median OS upon the introduction of the new therapies for metastatic melanoma. However, the long‐term OS benefit was limited, possibly because of racial differences in some of the clinical characteristics. To improve the overall melanoma prognosis, the entire treatment strategy, including perioperative therapy needs strengthening.     

Quality of Life and Social Isolation in Greek Adolescents with Primary Focal Hyperhidrosis Treated with Botulinum Toxin Type A: A Case Series

Primary hyperhidrosis, although extensively documented in adults, typically has onset that dates back to early childhood. It is an unpleasant and socially disabling problem for the affected child, but little attention has been paid to the disease in adolescents. The objective of the current study was to evaluate the effectiveness of botulinum toxin type A (BTXA) in adolescents with primary palmar and axillary hyperhidrosis and to determine its effect on quality of life and social isolation. Thirty‐five individuals (17 girls, 18 boys) with moderate to severe palmar and axillary hyperhidrosis were treated with BTXA (onabotulinum). Patients were examined at baseline and 6 months after treatment. The Hyperhidrosis Disease Severity Scale (HDSS) was used to evaluate disease severity and the Children's Dermatology Life Quality Index (CDLQI) was used to assess quality of life. The University of California at Los Angeles loneliness scale (UCLA version 3) was used to assess personal perception of loneliness and social isolation. The median age of the participants was 14 years, and 48.6% were female. Twenty‐one had palmar hyperhidrosis, and 14 had axillary hyperhidrosis. Total CDLQI and social isolation scores decreased significantly after treatment with BTXA (both p < 0.001). There was a significant difference between pre‐ and post‐treatment levels of severity of hyperhidrosis. No statistically significant difference was documented for CDLQI and UCLA scores between boys and girls. Treatment of hyperhidrosis with BTXA resulted in improvement in quality of life, social skills, and activities.     

Pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for treatment of axillary hyperhidrosis

BACKGROUND: Botulinum toxin type B (BTX-B, Myobloc, San Francisco, CA, USA) was FDA-approved for the treatment of cervical dystonia in December 2000. It has since been used off-label for the treatment of axillary hyperhidrosis. However, there are sparse data in the medical literature evaluating the safety and efficacy of Myobloc (botulinum toxin type B) for this indication. OBJECTIVE: To assess the safety, efficacy and duration of action of Myobloc (botulinum toxin type B) in the treatment of bilateral axillary hyperhidrosis. METHODS: This study was a double-blinded, randomized, pilot study conducted in an outpatient office setting at a private academic medical center beginning in November 2001. Twenty-three male and female volunteers between the ages of 18 and 80 were screened for participation; 20 participants with primary axillary hyperhidrosis were enrolled. Participants were injected subcutaneously with either Myobloc (botulinum toxin type B) (2500 U, or 0.5 ml, per axilla) or 0.5 ml vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/ml human albumin) into bilateral axillae. Participants who received placebo were rolled over and received Myobloc (botulinum toxin type B) at subsequent visits. All participants were followed until sweating returned to baseline levels. This trial was initially conceived as a placebo-controlled study; however, owing to the insufficient size of the placebo group, the placebo arm of this trial was dropped during data analysis. The main outcome measures were safety, efficacy, and duration of effect. RESULTS: According to participant assessment of axillary hyperhidrosis improvement (A-HI) and quality of life (A-HQOL) scores and the physician assessment scores, a significant difference was observed in treatment response at Day 30 in the participants receiving Myobloc (botulinum toxin type B) injections. Duration of action ranged from 2.2 to 8.1 months (mean 5.0 months). The adverse event profile included bruising, flu-like symptoms, and dry eyes. CONCLUSION: Myobloc (botulinum toxin type B) proved to be safe and efficacious for the treatment of bilateral axillary hyperhidrosis. More studies are needed to assess the duration of response using different doses of Myobloc (botulinum toxin type B).     

Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized,placebo‐controlled phase 3 trial

Tofacitinib is an oral Janus kinase inhibitor. These post‐hoc analyses assessed tofacitinib efficacy and safety in Japanese patients with psoriasis enrolled in a 52‐week global phase 3 study. Patients received tofacitinib 5 mg, tofacitinib 10 mg or placebo twice daily (b.i.d.); placebo‐treated patients advanced to tofacitinib at week 16. Primary efficacy end‐points were the proportions of patients with 75% or more reduction from baseline Psoriasis Area and Severity Index (PASI‐75) and Physician's Global Assessment (PGA) of “clear” or “almost clear” (PGA response) at week 16. Other end‐points included: Itch Severity Item (ISI), Dermatology Life Quality Index (DLQI) score and Nail Psoriasis Severity Index (NAPSI). Adverse events (AEs) were recorded throughout the study. Overall, 58 Japanese patients were included in this analysis (tofacitinib 5 mg b.i.d., n = 22; 10 mg b.i.d., n = 24; placebo, n = 12); 29 completed the study. At week 16, significantly more patients receiving tofacitinib 5 and 10 mg b.i.d. versus placebo achieved PASI‐75 (50% and 75% vs 0%, P < 0.01) and PGA response (59% and 75% vs 0%, P < 0.001). Substantial improvements in ISI, DLQI and NAPSI score were observed with both tofacitinib doses. Over 52 weeks, similar rates of AEs were reported across treatment groups; one serious AE occurred with tofacitinib 10 mg b.i.d. Herpes zoster occurred in three patients receiving tofacitinib 10 mg b.i.d. No deaths, serious infections, malignancies or gastrointestinal perforations were reported. Results were generally consistent with global analysis, suggesting sustained efficacy and a manageable safety profile, with increased herpes zoster incidence, of tofacitinib in Japanese patients with psoriasis.     

Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial

Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively inhibits interleukin‐23, a key cytokine in the pathogenesis of psoriasis, by binding to its p19 subunit. In SustaIMM (ClinicalTrials.gov/NCT03000075), a phase 2/3, double‐blinded, placebo‐controlled study, Japanese patients with moderate to severe plaque psoriasis (n = 171) were stratified by bodyweight and concomitant psoriatic arthritis and randomized 2:2:1:1 to 75 mg risankizumab, 150 mg risankizumab, placebo with cross‐over to 75 mg risankizumab and placebo with cross‐over to 150 mg risankizumab. Dosing was at weeks 0, 4, 16, 28 and 40, with placebo cross‐over to risankizumab at week 16. The primary end‐point was 90% or more improvement from baseline in Psoriasis Area and Severity Index (PASI‐90) at week 16 for risankizumab versus placebo. Missing data were imputed as non‐response. All primary and psoriasis‐related secondary end‐points were met for both risankizumab doses (P < 0.001). At week 16, PASI‐90 responses were significantly higher in patients receiving 75 mg (76%) or 150 mg (75%) risankizumab versus placebo (2%). Corresponding response rates were 86%, 93% and 10% for static Physician Global Assessment (sPGA) score of clear/almost clear; 90%, 95% and 9% for PASI‐75; and 22%, 33% and 0% for PASI‐100, with significantly higher responses for both risankizumab doses versus placebo. Through week 52, PASI and sPGA responses increased or were maintained and treatment‐emergent adverse events were comparable across treatment groups. Both doses of risankizumab were superior to placebo in treating patients with moderate to severe plaque psoriasis. The safety profile was consistent with previous risankizumab trials, with no new or unexpected safety findings.     

A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa

Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single‐center, single‐dose, open‐label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C‐reactive protein (CRP) levels were also measured. Forty‐three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified.     

Efficacy of injecting hybrid cooperative complexes of hyaluronic acid for the treatment of vulvar lichen sclerosus: A preliminary study

Background

Lichen sclerosus is a chronic relapsing inflammatory skin disease, which involves most commonly the anogenital region. The gold standard in treatment is ultra-potent topical steroids (clobetasol propionate): it aims at controlling the symptoms, stopping further scarring and distortion, and reducing the risk of cancer.

Objectives

The aim of this preliminary study is to evaluate the efficacy of injecting Hybrid Cooperative Complexes of Hyaluronic Acid (HCC) for the treatment of vulvar lichen sclerosus (VLS).

Methods

Twenty female adult patients (range: 21–78 years), aged over 18, with histopathological diagnosis of lichen sclerosus and good general conditions were enrolled. Patients underwent HCC infiltration every month, for 3 times. Patients were evaluated at baseline (T0) and after one (T1) and six months (T2) after treatment. During every visit, each patient was studied clinically and with videothermography. Itching, burning sensation, pain, and dyspareunia were reported by patients at T0, T1, and T2. The effectiveness of the treatment on patients’ quality of life and sexual function was evaluated using the Dermatology Life Quality Index (DLQI) and the Female Sexual Function Index (FSFI) at T0 and at T2.

Results

The results of this preliminary study are very promising, in fact, all patients had a significant reduction in most symptoms after 1 and 6 months of HCC treatment. The reduction of patients with itching (p value ≤ 0.001), pain (p value = 0.031), and burning sensation (p = 0.004) at 6 months is significant. The analysis of DLQI scores revealed a significant improvement in patients’ quality of life. At baseline, the average score of DLQI (±SD) was 5.89 ± 3.68 while at follow-up it was 3.42 ± 2.36 (p = 0.002).

Conclusions

Our preliminary study has demonstrated the validity and tolerability of HCC infiltrations in patients with VLS, and the effectiveness of HCC in reducing symptoms and, thus, to improve sexuality and patient quality of life.     

PASI90 response: the new standard in therapeutic efficacy for psoriasis

In a non‐life‐threatening disease such as psoriasis, treatment goals should be referred to the improvement in severity and extent of the disease and their impact on patients’ perceived health‐related quality of life (HRQoL), usually measured by the Dermatology Life Quality Index (DLQI). The ultimate goal of therapy is blanching, and an improvement of 90% or better (PASI90 response) with respect to baseline Psoriasis Area and Severity Index (PASI) is considered as treatment success by the European Medicines Agency. PASI75 response has become accepted as a less stringent reasonable therapeutic goal, but absolute PASI values might provide a better benchmark, irrespective of baseline PASI. Anyway, objective measures of psoriasis involvement are clinically meaningful only if they correlate with significant improvements in DLQI, and especially with the achievement of a DLQI = 0–1 status, corresponding to lack of effect of the disease on patient's HRQoL. Even though PASI75 response meets therapeutic expectations in most patients, PASI90 response or better has a significantly higher impact on DLQI improvement and is associated with significantly higher DLQI = 0–1 response rates. The introduction of anti‐IL17 drugs in clinical practice bears the promise of achieving PASI90 response or better in the majority of patients, and initial data suggest that the PASI90 benchmark provides better discriminatory value as regards achievement of DLQI = 0–1 response. Further research is required to confirm the value of absolute PASI cut‐offs as a measure of therapeutic success independent of baseline and duration of treatment, and to develop newer, more practical and more accurate measures of psoriasis severity.     

Plantar focal idiopathic hyperhidrosis and botulinum toxin: a pilot study

Botulinum toxin is a safe and effective treatment for idiopatic focal axillary and palmar hyperhidrosis, but very few data are reported in the literature on its effect on plantar idiopatic hyperhidrosis. The current study was undertaken to investigate the impact of BTX-A administration on sweat production and quality of life in patients suffering from plantar hyperhidrosis. Ten patients with idiopathic, recalcitrant plantar hyperhidrosis were included in a pilot study and underwent intradermal injections with 100 MU of BTX-A in the plantar skin, bilaterally. All the patients were followed for 16 weeks after treatment with objective (Minor's test) and subjective (DLQI test) evaluation. Patients experienced an improvement of symptoms with a significant decrease of Minor's test and DLQI levels for 12 weeks. No significant side effects occurred in any treated patient. BTX-A seems to be a promising treatment for plantar hyperhidrosis. However, clinical trials on larger patient series are needed in order to evaluate its safety and effectiveness for this application.