Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study.

BACKGROUND: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, a cornerstone cytokine in psoriasis, has shown long-lasting efficacy and safety in the complete spectrum of psoriasis manifestations. OBJECTIVES: To report the long-term (2·5-year) efficacy and safety of secukinumab in nail psoriasis. METHODS: TRANSFIGURE, a double-blind, randomized, placebo-controlled, parallel-group, multicentre phase IIIb study in 198 patients, investigated secukinumab 150 mg and 300 mg in patients with moderate-to-severe nail psoriasis. RESULTS: At week 16, the primary endpoint Nail Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of -73·3% and -63·6% with secukinumab 300 mg and 150 mg, respectively. At 2·5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) quality-of-life (QoL) scores of -52·4% and -18·1%, and 70% and 71% of patients achieved a weighted NAPPA Patient Benefit Index global score of ≥ 2 with secukinumab 300 mg and 150 mg, respectively. Patients showed considerable improvements in the EuroQol 5-Dimension health status questionnaire at 2·5 years, reporting a decrease in pain and discomfort. No new safety findings were observed. CONCLUSIONS: Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2·5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.

Sustained efficacy of secukinumab in patients with moderate-to-severe palmoplantar psoriasis: 2·5-year results from GESTURE, a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Secukinumab has shown sustained efficacy and safety in several manifestations of psoriasis. OBJECTIVES: GESTURE investigated the long-term (2·5-year) safety and efficacy of 150 mg and 300 mg subcutaneous secukinumab in 205 patients with moderate-to-severe palmoplantar psoriasis. METHODS: GESTURE was a randomized, double-blind, placebo-controlled, multicentre, phase IIIb trial conducted across 15 countries. The study was 140 weeks long and consisted of four periods: screening (up to 4 weeks), treatment period 1 (16 weeks), treatment period 2 (116 weeks) and post-treatment follow-up (8 weeks). Eligible patients were aged ≥ 18 years with moderate-to-severe palmoplantar psoriasis and at least one plaque outside of the palms and soles. Efficacy was assessed via a palmoplantar Investigator's Global Assessment (ppIGA) and the palmoplantar Psoriasis Area and Severity Index (PASI). RESULTS: The primary end point, a ppIGA score of 0 or 1, was met at week 16. The effect was sustained over 2·5 years with 59% [95% confidence interval (CI) 43·5-74·1] and 53% (95% CI 35·1-69·6) of patients in the secukinumab 300 mg and 150 mg groups, respectively, achieving clear or almost clear palms and soles (ppIGA 0 or 1). At 2·5 years, the mean palmoplantar PASI percentage was reduced in both the secukinumab 300 mg group (-74·7%) and the secukinumab 150 mg group (-61·6%). A total of 17% (secukinumab 300 mg group) and 18% (secukinumab 150 mg group) of patients experienced no difficulty in hands and feet functionality, as indicated by the palmoplantar quality of life instrument overall scores. The safety profile was favourable. CONCLUSIONS: GESTURE revealed that secukinumab provides a strong and sustained response over 2·5 years in challenging-to-treat palmoplantar psoriasis.

Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial.

BACKGROUND: Nail psoriasis is associated with functional impairment, pain and reduced quality of life. OBJECTIVES: To demonstrate the superiority of secukinumab over placebo in clearing nail psoriasis as assessed by the Nail Psoriasis Severity Index (NAPSI) at week 16 and over time up to week 132. Presented here is the week 32 interim analysis. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires. METHODS: TRANSFIGURE is a double-blind, randomized, placebo-controlled study in patients with moderate-to-severe plaque and nail psoriasis. RESULTS: The primary objective of this study was met: both doses of secukinumab were superior to placebo at week 16 (NAPSI improvements of -45·3%, -37·9% and -10·8% for secukinumab 300 mg and 150 mg and placebo, respectively, P < 0·001). Significant improvements were seen in patients' quality of life: the NAPPA-Quality of Life total score median decreases at week 16 were 60·9%, 49·9% and 15·8% for secukinumab 300 mg and 150 mg and placebo, respectively (P < 0·001). Improvement in nail psoriasis continued to week 32: NAPSI percentage change reached -63·2% and -52·6% for secukinumab 300 mg and 150 mg, respectively. Skin clearance measured by ≥ 90% improvement in Psoriasis Area and Severity Index was significant (rates of 72·5%, 54·0% and 1·7% for secukinumab 300 mg and 150 mg and placebo at week 16, respectively, P < 0·001) and was sustained to week 32. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections. CONCLUSIONS: Secukinumab demonstrated significant and clinically meaningful efficacy and quality-of-life improvements for patients with nail psoriasis up to week 32. What's already known about this topic? Nail psoriasis is understudied and there is a lack of effective treatment options. Nail psoriasis is correlated with more severe psoriatic disease and the development of psoriatic arthritis. What does this study add? TRANSFIGURE is one of the few prospective placebo-controlled trials specifically in nail psoriasis and includes nail-specific quality-of-life measures such as Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)-Quality of Life and NAPPA-Patient Benefit Index. In this trial, secukinumab demonstrates significant efficacy and quality-of-life improvements in this difficult-to-treat population.

Breast ptosis. Definition and treatment.

A definition of ptosis of the breast is given which permits differentiation of several kinds of defects to be made: pseudoptosis, partial ptosis, and true ptosis. In case of true ptosis, three degrees are described according to the nipple relation to the submammary fold and skin brassiere. An association with hypoplasia is described. The corrective techniques chosen are different according to the various types of ptosis and their possible association with various types of hypoplasia. The subpectoralis augmentation is used to insert the prosthesis in all cases.

Secondary thigh-buttock deformities after classical techniques. Prevention and treatment.

Secondary high-buttock corrections pose difficult problems because of the poor vascularization of certain areas, the limited mobilization of the soft tissue, and the tendency toward poor scar formation. These factors limit the surgical techniques available. The tendency for the deformity to recur may necessitate several corrective procedures. The authors discuss correction of supratrochanteric depressions, trochanteric bulges, scars, contour irregularities, perineal bands, and flat buttocks.

The minus-plus mastopexy.

The minus-plus mastopexy technique is designed for correction of moderate or major breast ptosis where breast volume is adequate but located in the lower quadrants and increased fullness in the upper quadrants is desired. The advantages of this procedure are absence of a medial scar, excellent projection, ensured nipple viability, speed, and flexibility.

Breast reduction: B technique.

The B breast reduction remains an excellent technique. It gives a small scar, well located, and a natural looking breast with good projection (Figs. 5, 6, and 7). In comparison to most classical techniques, the breast has less tendency to become flat with time, and the nipple-areola complex does not migrate up while the breast tissue sags down, but follows, like a nonoperated breast. It certainly is the method of choice in all kinds of mastopexies where it is useless to make long scars when short ones give a more aesthetic result.

Partially submuscular breast augmentation.

The partially submuscular implantation has not permanently impaired normal arm or shoulder movements. As the lower and medial origins are severed only as far superiorly as the 3rd rib, just a small portion of the whole muscle is affected. The breast looks natural because the prosthesis remains separated from the skin by the muscle in the upper portions. The contour of the gland, soft tissues, and implant creates a pleasing outline in the lower part. A palpable capsular formation has developed in only 6 percent of our cases, when examined after one year.

Abdominoplasty by the W technique.

The W abdominoplasty is an excellent esthetic operation (Figs. 7-12), based on several important principles. 1. The drawing of the W with its 3 angles gives 3 good landmarks for a symmetrical result. The mid-angle may be cut off by one to two cm at the time of closure, if it seems too sharp. 2. By making the incision inside the hairline, there is no increase in the height of the pubic hair. 3. By removing more tissues laterally than in the midline the traction on the flap is equalized, thus giving a nice draping on the hips. 4. The operation equalizes the wound edges and avoids producing skin folds. 5. Complete removal of the skin and fat between the umbilicus and the pubis is always possible if the operating table is put in a proper position for closure. No vertical scar has ever been necessary in our series. 6. The direction of the final scar, although different from the primary incision due to the traction, remains low-just above the inguinal fold and approximately in the same direction, in the area concealed by small bathing suits. 7. The maximum stretching of the abdominal skin favors a lasting result.

The Skoog rhinoplasty: a modified technique.

This study is a 6-year experience with 305 cases in which the technique was used for large noses. The techniques described is based on the Skoog rhinoplasty principle: autografting the osteocartilagineous nasal dorsum after its reduction to the best suitable shape and size, so that the osseous part of the graft lies on the remaining nasal bones. The authors have conjointly used the intracartilaginous approach, which leaves a unique scar away from the graft, and the extramucosal dissection, which keeps the graft separated from the nasal cavity by an intact mucosal lining. They also used the internal lateral osteotomy, which reduces postoperative swelling. The technique is described with all details. The cases shown demonstrate that this type of rhinoplasty prevents the middle third retraction because of the osteocartilaginous graft and most of the common secondary deformities. The analysis of results obtained in this series show 89 percent excellent (patient and surgeon pleased). Secondary correction had to be done in eight cases, by reducing or removing the graft.