scholarly journals Safety and Impact of Anti-COVID-19 Vaccines in Psoriatic Patients Treated with Biologics: A Real Life Experience

2021 ◽  
Vol 10 (15) ◽  
pp. 3355
Author(s):  
Nevena Skroza ◽  
Nicoletta Bernardini ◽  
Ersilia Tolino ◽  
Ilaria Proietti ◽  
Alessandra Mambrin ◽  
...  

Since all clinical trials conducted during the development of anti-COVID-19 vaccines have adopted among the exclusion criteria the presence of immunodepression or immunomodulating therapy, to date, the effects of vaccination against the new coronavirus 2 in people under such conditions have yet to be clearly defined. The primary objective of the study is to assess the safety of treatment with biotechnological drugs in patients suffering from moderate–severe psoriasis and subjected to the prophylactic vaccination against SARS-Cov-2. Additionally, the secondary objective of the research is to investigate the existence of a possible impact of anti-COVID-19 vaccination on the natural chronic-relapsing course and the severity of the psoriatic disease. The study included 436 patients with moderate–severe psoriasis, both male and female, in treatment with biologics. The data were collected using the direct interview method. A reduction of 74.13% of average Psoriasis Area Severity Index (PASI )compared to baseline (T0) was found in all subjects; this does not differ significantly from the group that underwent vaccination (73.4%). Moreover; at the end of the study, neither mild nor severe adverse events (ADR) were observed among them. In conclusion, biotechnological drugs used in the management of patients with moderate–severe psoriasis demonstrate a high safety profile also in subjects immunized against SARS-Cov-2.

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e032552 ◽  
Author(s):  
Bernd Schweikert ◽  
Chiara Malmberg ◽  
Mercedes Núñez ◽  
Tatiana Dilla ◽  
Christophe Sapin ◽  
...  

ObjectiveTo conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab.DesignA Markov model with a lifetime horizon and monthly cycles was developed based on the York model. Four health states were included: a biological disease-modifying antirheumatic drug (bDMARD) induction period of 12 or 16 weeks, maintenance therapy, best supportive care (BSC) and death. Treatment response was assessed based on both Psoriatic Arthritis Response Criteria (PsARC) and ≥90% improvement in the Psoriasis Area Severity Index score (PASI90). At the end of the induction period, responders transitioned to maintenance therapy. Non-responders and patients who discontinued maintenance therapy transitioned to BSC. Clinical efficacy data were derived from a network meta-analysis. Health utilities were generated by applying a regression analysis to Psoriasis Area Severity Index and Health Assessment Questionnaire‒Disability Index scores collected in the ixekizumab SPIRIT studies. Results were subject to extensive sensitivity and scenario analysis.SettingSpanish NHS.ParticipantsA hypothetical cohort of bDMARD-naïve patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis was modelled.InterventionsIxekizumab and secukinumab.ResultsIxekizumab performed favourably over secukinumab in the base-case analysis, although cost savings and quality-adjusted life-year (QALY) gains were modest. Total costs were €153 901 compared with €156 559 for secukinumab (difference −€2658). Total QALYs were 9.175 vs 9.082 (difference 0.093). Base-case results were most sensitive to the annual bDMARD discontinuation rate and the modification of PsARC and PASI90 response to ixekizumab or secukinumab.ConclusionIxekizumab provided more QALYs at a lower cost than secukinumab, with differences being on a relatively small scale. Sensitivity analysis showed that base-case results were generally robust to changes in most input parameters.Trial registration numberSPIRIT-P1: NCT01695239; Post-results, SPIRIT-P2: NCT02349295; Post-results.


2019 ◽  
Vol 7 ◽  
pp. 2050313X1984519 ◽  
Author(s):  
Misha Zarbafian ◽  
Benoit Cote ◽  
Vincent Richer

Treatment of moderate-to-severe psoriasis in patients with HIV infection is a clinical challenge. We present the case of a patient with a longstanding history of well-controlled HIV. He had failed topical management, and his hypertriglyceridemia made use of acitretin potentially unsafe. He was unable to regularly attend a phototherapy unit. Physical examination revealed 12% total body surface area involvement with a Psoriasis Area Severity Index (PASI) of 10.2. His Dermatology Quality of Life Index (DLQI) was 20. After 3 months of apremilast treatment, his PASI decreased to 4.1. After 7 months, his PASI decreased to 2.7 and his DLQI to 1. Two years later, his PASI score was 2.4, with a stable CD4 count of 1200 cells/mm3 and an undetectable viral load. There were no serious opportunistic infections or laboratory abnormalities. To our knowledge, this represents the second reported case of psoriasis treatment with apremilast in a patient with HIV.


Author(s):  
R. Rajasudhakar

Background: Sulcus vocalis is a structural deformity of the vocal ligament. It is the focal invagination of the epithelium deeply attaching to the vocal ligament. There is a dearth of literature on the outcome of voice therapy in sulcus vocalis condition.Objective: The primary objective of this study was to document voice characteristics of sulcus vocalis and the secondary objective was to establish the efficacy of voice therapy in a patient with sulcus vocalis.Method: A trial of voice therapy was given to the client who was diagnosed as having sulcus vocalis. Boon’s facilitation techniques were used in voice therapy along with other techniques such as breath holding and push and pull approach prior to surgery. Acoustic, aerodynamic, perceptual, quantitative measures of voice quality and self-rating measurements were performed before and after voice therapy.Results: Improvement was noticed in 10/10 acoustic, 4/4 aerodynamic, perceptual, dysphonia severity index and voice handicap index scores, which hinted that voice therapy can be an option critically for clients with sulcus vocalis in the initial stage.Conclusion: Voice therapy showed promising improvement in the study and it must be recommended as the initial treatment option before any surgical management.


2020 ◽  
Vol 9 (7) ◽  
pp. 2170 ◽  
Author(s):  
Marco Galluzzo ◽  
Lorenzo Tofani ◽  
Paolo Lombardo ◽  
Alessandra Petruzzellis ◽  
Dionisio Silvaggio ◽  
...  

Little information is available from real-life studies evaluating the efficacy of guselkumab in moderate-to-severe psoriasis. In this real-life study, we retrospectively examined a database of 52 patients with moderate-to-severe psoriasis treated with guselkumab (100 mg, s.c.) and followed for 1 year. Disease severity and treatment response was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 4, 12, 20, 28, 36, 44, and 52 weeks. Predictors of a PASI response were evaluated by univariate and multivariate regression. After 12 months, 84.2% of patients (mean age 51.3 ± 14.1 years) treated with guselkumab achieved a PASI score of <3. Furthermore, PASI score decreased from 20 ± 13.3 at baseline to 4.4 ± 4.7 and 2.7 ± 3.9 at 12 and 20 weeks, and PASI 75, 90, and 100 response was achieved in 84.2%, 78.9%, and 63.2% of patients respectively at 12 months. Stepwise multivariate regression analysis revealed that previous biological treatment and the presence of comorbidities were associated with poorer response between 28–44 weeks, however the presence of obesity per se was not associated with poorer response. Difficult-to-treat areas were also improved as early as 12 weeks following guselkumab. Guselkumab was observed to be effective and safe in patients with moderate-severe chronic psoriasis in a real world-setting.


Author(s):  
Matteo Megna ◽  
Gabriella Fabbrocini ◽  
Eleonora Cinelli ◽  
Elisa Camela ◽  
Angelo Ruggiero

2017 ◽  
Vol 29 (5) ◽  
pp. 481-486 ◽  
Author(s):  
Carlo Giovanni Carrera ◽  
Paolo Dapavo ◽  
Piergiorgio Malagoli ◽  
Luigi Naldi ◽  
Luisa Arancio ◽  
...  

2019 ◽  
Vol 32 (3) ◽  
pp. 214 ◽  
Author(s):  
Inês Raposo ◽  
Andreia Bettencourt ◽  
Luiz Leite ◽  
Manuela Selores ◽  
Tiago Torres

Introduction: Ustekinumab is a monoclonal antibody directed against the p40 subunit common to both IL-12 and IL-23 cytokines. Although the evidence of ustekinumab efficacy and safety in clinical trials is extensively recognized, data on its use in clinical practice is limited. Our objective is to report on the real-life experience of two Portuguese dermatology departments with ustekinumab in patients with moderate to severe psoriasis, and to identify the clinical characteristics associated with a weaker clinical response.Material and Methods: Clinical, demographic, and therapeutic response data was retrospectively collected in 116 patients with moderate to severe psoriasis treated with ustekinumab between November 2009 and December 2015.Results: A PASI75 therapeutic response was observed in 67.2%, 85.3%, 89.6% and 88.7% of patients at weeks 4, 12, 24 and 52, respectively. Ustekinumab was discontinued in seven patients (three due to primary failure, three due to secondary treatment failure, and one due to adverse events). Neither cardiovascular events nor cases of reactivation of previous infections (tuberculosis, hepatitis B) were observed during follow-up. In nine patients methotrexate was used as adjuvant therapy, and fourteen patients required ustekinumab dosage optimization. No side effects were observed in the two latter groups. The therapeutic response was higher in patients naïve to biologic therapies as compared to non-naïve patients.Discussion and Conclusion: A trend towards lower clinical response was observed in patients weighing between 90-100 kg, and dosage optimization in this group of patients may be of value prior to considering biologic switch.


Author(s):  
Niken Kusumaningrum ◽  
Danar Wicaksono ◽  
Dwi Retno Adi Winarni ◽  
Yohanes Widodo Wirohadidjojo ◽  
Sunardi Radiono

Methotrexate is the drug of choice used on moderate to severe psoriasis. The limited availability of oral tablet methotrexate stimulates the initiation of the protocol therapy 50 mg intramuscular methotrexate weekly in six consecutive weeks for severe psoriasis cases. There were 30 cases treated using this treatment modality. Twenty-six cases (86%) showed a good response and achieved PASI-90(Psoriasis Area Severity Index-90), four cases (13%) showed a slow response and did not achieve PASI-90. This case report collected slow response cases and identified their risk factor of slow responsiveness with this treatment modality. The comorbidity condition like metabolic syndrome, drugs induced psoriasis, continuous trauma, the side effect of methotrexate administration (ulceration), or the possibility of allergic or irritant contact dermatitis from occupation are suspected to be the risk factor for slow responders in this treatment modality.


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