Certolizumab Pegol in the Treatment of Psoriasis and Psoriatic Arthritis: Preliminary Real-Life Data

Dattola, Annunziata; Cannizzaro, Maria Vittoria; Mazzeo, Mauro; Bianchi, Luca

doi:10.1007/s13555-017-0208-z

Cited by 21 publications

(16 citation statements)

References 13 publications

(14 reference statements)

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“…Certolizumab was generally well tolerated, with infections being the most common AEs (after exclusion of worsening of disease), although none were considered serious. A previous observational study (n = 44) in psoriatic arthritis patients also found no serious infections, 18 and certolizumab phase II-III clinical trials also reported the majority of AEs to be of mild-tomoderate severity. [13][14][15][16] The profile of the most common AEs in this study was slightly different to that of the latter trials, where nasopharyngitis, upper respiratory tract infections and headache were generally the most common AEs.…”

Section: Discussionmentioning

confidence: 65%

“…25 Evidence from two realworld studies further supports the effectiveness of certolizumab for the joint involvement of psoriatic arthritis and the skin component of those with skin involvement/psoriasis. 17,18 Approximately one-third of the certolizumab recipients in the certolizumab phase III clinical trials had previously received biologic therapy. 14,15 It is interesting to note that in this study, a larger proportion of patients [105/153 (69%)] had previously received biologics.…”

Section: Discussionmentioning

confidence: 99%

“…[14][15][16] These clinical trial results are supported by preliminary data from real-world studies, in which certolizumab was associated with rapid and significant improvements in joint and skin involvement, as well as improvements in nail psoriasis, and was well tolerated. [17][18][19] The aim of our study was to confirm the effectiveness and safety of certolizumab in patients with psoriatic arthritis and psoriasis receiving treatment in a routine clinical practice setting in Italy.…”

Section: Introductionmentioning

confidence: 99%

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

Dattola

Balato

Megna

et al. 2020

Acad Dermatol Venereol

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Background Certolizumab, a pegylated tumour necrosis factor-a 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.

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Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Dattola

Balato

Megna

et al. 2020

Acad Dermatol Venereol

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“…These features of CZP may be attributable to the PEGylation and the smaller molecular weight, as compared with IFX and ADA. A recent study also additionally showed that CZP monotherapy was an effective and well-tolerated therapeutic alternative for the treatment of psoriasis and psoriatic arthritis, although this study did not discuss the ophthalmic complications [11]. Llorenç et al [12] examined 7 patients with refractory uveitis, 2 of whom had psoriatic arthritis.…”

Section: Discussionmentioning

confidence: 99%

Successful Certolizumab Pegol Treatment of Chronic Anterior Uveitis Associated with Psoriasis Vulgaris

Yamaguchi

Hayashi

Takahashi

et al. 2018

Case Rep Ophthalmol

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This report presents details on a 45-year-old male Japanese patient with chronic and refractory anterior uveitis associated with psoriasis vulgaris who was administered certolizumab pegol (CZP), which is an anti-tumor necrosis factor alpha (TNF-α) monoclonal antibody. Although CZP has only been formally approved for rheumatoid arthritis treatment in Japan, a clinical trial allowed us to assess CZP effectiveness in this patient. The grade 3+ anterior chamber inflammation (for both the cells and flare) observed at baseline improved to grade 0 at 3 months post-treatment. Dermatologically, the psoriasis area severity index (PASI) score was 25.4, while the body surface area (BSA) was 88% at baseline. At 3 months after treatment, the scores improved to 2.8 for PASI and less than 1% for BSA. After the treatment, remission has lasted for at least 9 months. No adverse events were seen during the CZP treatment. These findings suggest that CZP could be an effective therapeutic alternative in some refractory anterior uveitis patients with psoriasis vulgaris.

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“…In precedent studies finalized to evaluate CZP efficacy on PsA, our group noticed that the drug was effective also on cutaneous involvement 5 …”

Section: Introductionmentioning

confidence: 99%

Clinical efficacy and safety of certolizumab pegol in cutaneous symptoms on psoriasis in patients with psoriatic arthritis: A retrospective analysis in real life

Dattola

Mazzeo

Stefano

et al. 2020

Dermatologic Therapy

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We present the results on retrospective analysis about the efficacy of Certolizumab pegol (CZP), an antitumor necrosis factor‐alpha agent, as monotherapy on skin psoriasis (PsO) in patients affect both by psoriatic arthritis (PsA) and mild‐severe PsO. To date, the CZP is authorized for the treatment of PsA, PsO beyond that rheumatoid arthritis, axial spondyloarthritis/ankylosing spondylitis, and Crohn's. Assessments included an evaluation of the Psoriasis Area and Severity Index (PASI). Twelve patients (9M and 3F mean age 57.8 ± 8 years) were enrolled in our study. Nine patients had been previously treated with others biologic agents, three patients were naïve. Clinical and laboratory evaluations including PASI, erythrosedimentation rate, and C‐reactive protein were performed at baseline (BL), at Week 12 (W12), Week 24 (W24), and Week 52 (W52) of treatment. Although the combination between methotrexate and CZP is allowed, we included, in our study, patients treated only with CZP. In such a way as to be as specific as possible, topical corticosteroids, vitamin D derivatives, retinoid creams, anthralin derivatives as well as p‐UVA or UV‐B have been forbidden to enrolled patients. With the same purpose, all the patients used the identical moisturizing cream two times a day. Mean PASI score decreased from 18 (BL) to 0 (W52) as follows: 18 at BL, 4 at W12, 0 at W24, and 0 at W52. Severe adverse events were not reported. Safety evaluations were performed every 3 months: liver and renal functions were monitored in all patients during the treatment, and no patient presented abnormal values. To the best of our knowledge, this is the first report that highlights the efficacy of CZP as monotherapy in psoriasis with mild to severe cutaneous involvement. Although to date the drug is authorized only for PsA, our results demonstrate that CZP is safe and effective on both cutaneous and joint components representing, therefore, an effective option in the treatment of cutaneous symptoms of PsO. Limitations of our study are presented by the relatively short observation time (W52) and by numeric small study group. Long‐term data with a larger number of enrolled patients are necessary in order to confirm our preliminary observations.

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Certolizumab Pegol in the Treatment of Psoriasis and Psoriatic Arthritis: Preliminary Real-Life Data

Cited by 21 publications

References 13 publications

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

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

Successful Certolizumab Pegol Treatment of Chronic Anterior Uveitis Associated with Psoriasis Vulgaris

Clinical efficacy and safety of certolizumab pegol in cutaneous symptoms on psoriasis in patients with psoriatic arthritis: A retrospective analysis in real life

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