Secukinumab is effective in the treatment of recalcitrant palmoplantar psoriasis and palmoplantar pustular psoriasis in a daily practice setting

Abstract

To the Editor: Secukinumab (SEC) has been found to be effective in the treatment of palmoplantar psoriasis and palmoplantar pustular psoriasis in clinical trials.1Gottlieb A.B. Kubanov A. van Doorn M. et al.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.Br J Dermatol. 2020; 182: 889-899Crossref PubMed Scopus (11) Google Scholar, 2Gottlieb A. Sullivan J. van Doorn M. et al.Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial.J Am Acad Dermatol. 2017; 76: 70-80Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar, 3Mrowietz U. Bachelez H. Burden A.D. et al.Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: results of the 2PRECISE study.J Am Acad Dermatol. 2019; 80: 1344-1352Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 4Mrowietz U. Bachelez H. Burden A.D. et al.Efficacy and safety of secukinumab in moderate to severe palmoplantar pustular psoriasis over 148 weeks: extension of the 2PRECISE study.J Am Acad Dermatol. 2021; 84: 552-554Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar However, there are few published reports in daily practice (Supplementary Table 1, available via Mendeley at https://data.mendeley.com/datasets/f23v4y62hd/1). Our objective was to assess the result of SEC on effectiveness, quality of life, persistence, and safety of patients with palmoplantar psoriasis and palmoplantar pustular psoriasis in a real clinical practice setting. The study design, data collection, and analysis were approved by the ethics committee of Hospital Universitario de la Princesa (EDT-SIA-2017-01). Individually written informed consents were obtained from patients at the beginning of the study. A retrospective, observational, multicenter, cohort study of adult patients with moderate-to-severe palmoplantar psoriasis and palmoplantar pustular psoriasis (palmoplantar psoriasis 5-point Investigator Global Assessment scale [ppIGA]/palmoplantar pustular psoriasis 5-point Investigator Global Assessment scale [pppIGA] score of ≥3) with at least 1 additional erythematous scaly plaque outside the palms and soles, treated with an initial standard dose regimen of SEC under daily practice conditions, was conducted between January 2014 and July 2020, with a follow-up period of 3 to 24 months. The patients were considered “responders” when a ppIGA/pppIGA score of 0 or 1 or a reduction of at least 2 points on the ppIGA/pppIGA scale from the baseline was achieved. Seventy-two patients were included (Table 1).5Langley R.G.B. Feldman S.R. Nyirady J. et al.The 5-point Investigator’s Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials.J Dermatolog Treat. 2015; 26: 23-31Crossref PubMed Scopus (124) Google Scholar At the 24-month follow-up, 56.36% and 52.94% (last observation carried forward) and 87.50% and 100% (as observed) of patients with palmoplantar psoriasis and palmoplantar pustular psoriasis, respectively, were responders (Fig 1). Notably, we found that, in both groups, approximately 47% of the subjects became responders after only 3 months (last observation carried forward and as observed). At 12 months, a higher effectiveness (ppIGA) in biologic-naïve patients with palmoplantar psoriasis versus those who were biologic-experienced was observed (P < .043). No differences were found when effectiveness was correlated with obesity (body mass index of ≥30 kg/m2) or psoriatic arthritis. The mean therapy duration was 12.7 months (95% CI, 10.5-14.9 months) and 13.4 months (95% CI, 9.5-17.3 months) for patients with palmoplantar psoriasis and palmoplantar pustular psoriasis, respectively. The observed cumulative duration therapy rates at 6, 12, 18, and 24 months were 81.36%, 54.24%, 39.98%, and 27.12%, respectively, in the palmoplantar psoriasis group and 82.35%, 52.94%, 41.18%, and 29.41%, respectively, in the palmoplantar pustular psoriasis group (Supplementary Fig 1A, available via Mendeley at https://data.mendeley.com/datasets/f23v4y62hd/1). Biologic-naïve patients with palmoplantar psoriasis were more likely to continue the treatment than biologic-experienced patients (log rank, P = .005) (Supplementary Fig 1B). Patients with both palmoplantar psoriasis and palmoplantar pustular psoriasis showed a consistent reduction in Dermatology Life Quality Index (decrease of around 10 points) (Supplementary Fig 2, available via Mendeley at https://data.mendeley.com/datasets/f23v4y62hd/1). SEC was overall well-tolerated, with only 7 (9.7%) nonfatal serious adverse events.Table IBaseline sociodemographic and clinical characteristics of patientsBaseline characteristicsPalmoplantar psoriasis (N = 55)Palmoplantar pustular psoriasis (N = 17)Male sex, n (%)28 (50.9)6 (35.3)Age (y), mean ± SD54.04 ± 12.1352.47 ± 13.26Weight (kg), mean ± SD75.19 ± 14.1473.36 ± 12.93Body mass index (kg/m2), mean ± SD28.52 ± 4.6128.56 ± 4.73Time since palmoplantar psoriasis diagnosis (y), mean ± SD10.12 ± 8.8412.84 ± 11.40ppIGA/pppIGA score,∗The ppIGA/pppIGA were based on the modified version of the Investigator Global Assessment scale specifically applied to the palms and soles.5 n (%) 3 (moderate)28 (50.9)4 (23.5) 4 (severe)27 (49.1)13 (76.5)Dermatology Life Quality Index, median1214Psoriatic arthritis, n (%)15 (27.3)7 (41.2)Combination therapy, n (%)1 (1.8)3 (17.7)Methotrexate, n (%)0 (0)2 (11.8)Acitretin, n (%)1 (1.8)0 (0)Corticosteroids, n (%)0 (0)1 (5.9)Previous exposure to nonbiologic systemic therapy, n (%)52 (94.5)17 (100) 1 nonbiologic systemic therapy15 (27.3)7 (41.2) 2 nonbiologic systemic therapies15 (27.3)4 (23.5) ≥3 nonbiologic systemic therapies22 (40)6 (35.2) Methotrexate, n (%)36 (65.5)12 (70.6) Ciclosporine A, n (%)22 (40.7)10 (58.8) Acitretin, n (%)41 (74.5)10 (58.8) Alitretinoin, n (%)0 (0)1 (5.9) PUVA/narrowband UV-B therapy, n (%)17 (30.9)3 (17.6)Previous exposure to apremilast, n (%)16 (29.1)4 (23.5)Previous exposure and failure to biologic therapies, n (%)26 (48.1)8 (47.1) 1 biologic16 (29.6)0 (0) 2 biologics5 (9.3)4 (23.5) ≥3 biologics5 (9.3)4 (23.6) Efalizumab, n (%)1 (1.8)0 (0) Infliximab, n (%)5 (9.3)1 (5.9) Adalimumab, n (%)18 (33.3)7 (41.2) Etanercept, n (%)12 (22.2)2 (11.8) Ustekinumab, n (%)7 (13.5)4 (23.5)ppIGA, Palmoplantar psoriasis 5-point Investigator Global Assessment scale; pppIGA, palmoplantar pustular psoriasis 5-point Investigator Global Assessment scale; PUVA, psoralen plus UV-A.∗ The ppIGA/pppIGA were based on the modified version of the Investigator Global Assessment scale specifically applied to the palms and soles.5Langley R.G.B. Feldman S.R. Nyirady J. et al.The 5-point Investigator’s Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials.J Dermatolog Treat. 2015; 26: 23-31Crossref PubMed Scopus (124) Google Scholar Open table in a new tab ppIGA, Palmoplantar psoriasis 5-point Investigator Global Assessment scale; pppIGA, palmoplantar pustular psoriasis 5-point Investigator Global Assessment scale; PUVA, psoralen plus UV-A. Comparing our results with those from the clinical trials GESTURE/PRECISE, we found a faster and more effective response in the short-term (ppIGA 0/1 in 47.27% of the patients at week 12 versus 33.3% at week 161Gottlieb A.B. Kubanov A. van Doorn M. et al.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.Br J Dermatol. 2020; 182: 889-899Crossref PubMed Scopus (11) Google Scholar,2Gottlieb A. Sullivan J. van Doorn M. et al.Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial.J Am Acad Dermatol. 2017; 76: 70-80Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar and pppIGA 0/1 in 47.06% of the patients at week 12 versus 26.6% achieved PPPASI75 at week 163Mrowietz U. Bachelez H. Burden A.D. et al.Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: results of the 2PRECISE study.J Am Acad Dermatol. 2019; 80: 1344-1352Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar,4Mrowietz U. Bachelez H. Burden A.D. et al.Efficacy and safety of secukinumab in moderate to severe palmoplantar pustular psoriasis over 148 weeks: extension of the 2PRECISE study.J Am Acad Dermatol. 2021; 84: 552-554Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar). However, in the long term, the results seemed to be very similar for palmoplantar psoriasis group (ppIGA 0/1 in 59% of the patients at 2.5 years in the GESTURE trial1Gottlieb A.B. Kubanov A. van Doorn M. et al.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.Br J Dermatol. 2020; 182: 889-899Crossref PubMed Scopus (11) Google Scholar versus 56.36% of responders in our study at 2 years) and better results in the PRECISE trial (78.3% of patients achieved PPPASI75 at 2.5 years4Mrowietz U. Bachelez H. Burden A.D. et al.Efficacy and safety of secukinumab in moderate to severe palmoplantar pustular psoriasis over 148 weeks: extension of the 2PRECISE study.J Am Acad Dermatol. 2021; 84: 552-554Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar versus 52.94% of responders in our study at 2 years). In summary, in our experience, SEC is a fast and effective alternative for the treatment of a number of patients with refractory palmoplantar psoriasis and palmoplantar pustular psoriasis. Dr Reolid has participated in clinical trials of and received honoraria for speaking from Almirall, Janssen, LEO Pharma, Lilly, and Novartis, not related with the submitted work. Dr Armesto has received honoraria for speaking from AbbVie/Abbott, Almirall, Amgen, Janssen-Cilag, LEO Pharma, Novartis, and Lilly. Dr Sahuquillo-Torralba has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Dr Torres has received honoraria for acting as a consultant and/or as a speaker from AbbVie, Almirall, Amgen, Arena Pharmaceuticals, Biocad, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, MSD, Novartis, Pfizer, Samsung-Bioepis, Sandoz, and Sanofi. Dr Feltes has participated in clinical trials for drug development of Novartis, Lilly, UCB, Jannsen-Cilag, Almirall, Pfizer, LEO Pharma, and AbbVie. Dr Vilarrasa is an advisory board member for; consultant for; receives honoraria for speaking from; and has participated in clinical trials of AbbVie/Abbott, Almirall, Amgen, Celgene, Janssen-Cilag, LEO Pharma, Lilly, MSD-Schering-Plough, Novartis, Pfizer, and UCB. Dr Belinchón is a consultant and/or speaker for and/or has participated in clinical trials sponsored by Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Amgen, LEO Pharma, Pfizer-Wyeth, UCB, and MSD. Dr de la Cueva is an advisory board member for; consultant for; receives honoraria for speaking from; and has participated in clinical trials of AbbVie, Almirall, Astellas, Biogen, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, not related with the submitted work. Dr Rodríguez has served as a consultant and speaker for AbbVie, Janssen Pharmaceuticals Inc, MSD, Pfizer-Wyeth, Novartis, Celgene, Almirall SA, Lilly, and LEO Pharma. Dr Romero-Maté has participated in advisory boards, acted as consultant, participated in clinical trials, and has received honoraria for speaking from Pfizer, Celgene, Novartis, UCB, LEO Pharma, Almirall, and Lilly. Dr Vidal is a consultant and investigator for AbbVie, Janssen, Novartis, Celgene, Lilly, and LEO Pharma. Dr Coto-Segura has participated in advisory boards or received grants, research support, and honoraria for speaking from AbbVie, Janssen-Cilag, Novartis, Pfizer, Celgene, Lilly, and UCB. Dr Herrera-Acosta is an advisory board member for; consultant for; receives grants, research support, and honoraria for speaking from; and has participated in clinical trials of AbbVie/Abbott, Almirall, Amgen, Janssen-Cilag, LEO Pharma, Novartis, Celgene, Lilly, and UCB. Dr Riera-Monroig has served as a consultant and/or paid speaker for and/or participated in clinical trials of Janssen, Novartis, UCB, Lilly, AbbVie, and LEO Pharma. Dr Salgado is an advisory board member for; consultant for; receives grants, research support, and honoraria for speaking from; and has participated in clinical trials of AbbVie, Almirall, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, MSD-Schering-Plough, Celgene, Lilly, and UCB. Dr Llamas-Velasco is an advisory board member for; consultant for; receives research support and honoraria for speaking from; and has participated in clinical trials of AbbVie, Almirall, Amgen, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, Novartis, and UCB, not related with the submitted work. Dr Dauden is an advisory board member for; consultant for; receives grants, research support, and honoraria for speaking from; and has participated in clinical trials of AbbVie/Abbott, Almirall, Amgen, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, MSD-Schering-Plough, Celgene, Lilly, and UCB. The authors thank Andrés Mejia and Manuel Gómez Gutierrez for their valuable comments on this manuscript.