Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

Correr, Cassyano Januário; Rotta, Inajara; Teles, Thaís de Souza; Godoy, Rangel Ray; Riveros, Bruno Salgado; Garcia, Mariana Martins; Gonçalves, Patrícia Rodrigues; Otuki, Michel Fleith

doi:10.1590/0102-311x00157013

Cited by 4 publications

(5 citation statements)

References 85 publications

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“…Ustekinumab is considered to be well tolerated, most adverse events are mild and do not require dosage adjustment or cessation of therapy [ 17 ]. Clinical trial data available so far indicate no increased incidence of severe infections compared to placebo or other biologicals and no specific patterns of infection could be observed [ 9 , 11 – 13 , 17 , 18 ]. The PSOLAR registry included 4134 patients receiving ustekinumab.…”

Section: Discussionmentioning

confidence: 99%

“…Multiple psoriatic lesions were present. Laboratory analysis revealed a leukocytosis of 23 × 10 [ 9 ] cells/L, a reduced platelet count of 66 × 10 [ 9 ] cells/L, a C-reactive protein level of 154 mg/L [<5 mg/L], a procalcitonin of 4.67 ng/mL [<0.5 ng/mL], a blood urea nitrogen of 93 mg/dl, a serum creatinine of 1.16 mg/dl and an INR 1.35. A CT scan on the day of admission showed no signs of arthritis, joint effusion or empyema in the right ankle joint.…”

Section: Case Presentationmentioning

confidence: 99%

“…A pre-treatment tuberculosis screen is recommended. However, in large multicenter trials infection rates were not elevated compared to other biologicals or non-biological immunosuppressive agents [ 9 – 14 ].…”

Section: Introductionmentioning

confidence: 99%

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Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab

et al. 2016

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BackgroundUstekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far.Case presentationHere, we report the case of a 64-year old woman presenting with chills, pain and swelling of her right foot with dark maculae at the sole, and elevated inflammatory markers. She had received a third dose of ustekinumab due to psoriatic arthritis three days before admission. Blood cultures revealed growth of Staphylococcus aureus and imaging showed a thickening of the aortic wall ventral the bifurcation above the right internal iliac artery, resembling an acute bacterial endarteritis. Without the evidence of aneurysms and in absence of foreign bodies, the decision for conservative management was made. The patient received four weeks of antibiotic therapy with intravenous flucloxacillin, followed by an oral regime with levofloxacin and rifampicin for an additional four weeks. Inflammatory markers resolved promptly and the patient was discharged in good health.ConclusionTo our knowledge, this is the first report of a severe S. aureus infection in a patient receiving ustekinumab. Albeit ustekinumab is generally regarded as a safe drug, severe bacterial infections should always be included in the differential diagnosis of elevated inflammatory markers in patients receiving biologicals as these might present with nonspecific symptoms and fever might be absent. Any effort to detect deep-seated or metastatic infections should be made to prevent complications and to secure appropriate treatment. Although other risk factors for an invasive staphylococcal infection like psoriasis, recent corticosteroid injection, or prior hospitalisations were present, and therefore a directive causative link between the S. aureus bacteraemia and ustekinumab can not be drawn, we considered the reporting of this case worthwhile to alert clinicians as we believe that ongoing pharmacovigilance to detect increased risks for rare but severe infections beyond phase II and phase III trials in patients treated with biologicals is essential.

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Section: Discussionmentioning

confidence: 99%

Section: Case Presentationmentioning

confidence: 99%

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Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab

et al. 2016

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“…This pharmacoeconomic study is part of a broader project that involved systematic reviews of clinical efficacy and safety [17] and patient-related outcomes. Moreover, a mixed treatment comparison for these three outcomes and a benefit-risk multicriteria decision analysis were carried out.…”

Section: Methodsmentioning

confidence: 99%

Cost-Effectiveness of Biologic Agents in the Treatment of Moderate-to-Severe Psoriasis: A Brazilian Public Health Service Perspective

Riveros

Ziegelmann

Correr

2014

Value in Health Regional Issues

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From the pharmacoeconomics point of view, adalimumab 80 mg at week 0 followed by a maintenance dose of 40 mg at week 1 and then every other week should be the first-line therapy for patients with plaque psoriasis concomitant or not to psoriatic arthritis or nail psoriasis. This study does not have the potential to evaluate the impact of incorporating a specific biologic agent on the final budget. Its goal is to point out which of the technologies is the most efficient, that is, the one that adds more value to the financial resource invested.

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“…The statistical heterogeneity among studies was evaluated by Cochran's Q test ( P < .05 indicates significant heterogeneity) and I 2 statistics. If I 2 = 0%‐25%, the compared studies do not have heterogeneity; if I 2 = 25%‐50%, the compared studies have mild heterogeneity; if I 2 = 75%‐100%, the compared studies have severe heterogeneity 20 . We also conducted a sensitivity analysis of studies with high heterogeneity in pair‐wise comparisons to assess their stability.…”

Section: Evidence Quality Assessmentmentioning

confidence: 99%

A network meta‐analysis for the comparison of efficacy and safety of interleukin ( IL )‐23 targeted drugs in the treatment of moderate to severe psoriasis

Jian-zhen

Chen

2020

Dermatologic Therapy

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A variety of interleukin‐23 targeted drugs have been used to treat moderate to severe psoriasis, but it is not clear which is most effective. This network meta‐analysis compared and summarized the short‐term efficacy and safety of interleukin‐23 (IL‐23) targeted drugs in the treatment of moderate to severe psoriasis. PubMed, Embase, Web of Science, and Cochrane Library were used to search randomized controlled trials (RCTs) about the treatment of moderate to severe psoriasis with ustekinumab (Ust), guselkumab (Gus), tildrakizumab (Til), and risankizumab (Ris). Bayesian Network Meta‐analysis (NMA) was used to calculate Psoriasis Area and Severity Index 75%, 90%; Physician Global Assessment score of 0 or 1 (PGA 0/1); Dermatology Life Quality Index of 0 or 1 (DLQI 0/1), and safety (adverse events [AEs]) effect estimates (odds ratio OR) and 95% confidence intervals. Direct, indirect, and network meta‐analysis estimates were calculated using a random‐effects model. The GRADE method was used to assess the quality of evidence for each pair‐wise comparison. In addition, the surface under the cumulative ranking curve (SUCRA) analysis was used to rank the treatment level for each outcome indicator. This network meta‐analysis included 14 RCTs with 8402 patients. The results indicate that the curative effect of the IL‐23 targeted drugs is better than that of a placebo. Network meta‐analysis showed that Ris90 mg and Ris180 mg were significantly more effective than Til (5, 25, 100, and 200 mg), Ust (45 mg, 90 mg, body weight‐based administration), Gus 100 mg and Ris (75 and 150 mg). Regarding safety, there is no significant difference in the risk of adverse events between drugs targeting IL‐23 and placebo. In addition, according to the ranking of SUCRA, Ris 90 mg has the best efficacy index for PASI 75 and PGA 0/1, with SUCRA values of 97.6% and 97.1%, respectively. Ris 180 mg ranked first in PASI 90 (91.1%), while Ris 75 mg performed best in DLQI 0/1 (73.7%). In this network meta‐analysis, risankizumab showed the best curative effect in the short‐term treatment of moderate to severe psoriasis, and the risk of adverse events was not significantly different from placebo. However, more research data are needed for further study in the field of cost to evaluate which drug strikes the most favorable balance among efficacy, safety, and cost of access.

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Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

Cited by 4 publications

References 85 publications

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab

Cost-Effectiveness of Biologic Agents in the Treatment of Moderate-to-Severe Psoriasis: A Brazilian Public Health Service Perspective

A network meta‐analysis for the comparison of efficacy and safety of interleukin ( IL )‐23 targeted drugs in the treatment of moderate to severe psoriasis

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