Ustekinumab in the treatment of psoriasis
Bibliographic record
Abstract
Psoriasis treatment is often challenging, requiring long-term pharmacotherapeutic regimens that should be tailored to patients’ specific expectations rather than to the extent of their disease. Classic approaches provided varying degrees of efficacy in the management of psoriasis. A significant therapeutic improvement has been obtained with the introduction of biologics, which have been suggested to have a more favorable safety profile and efficacy, compared to conventional therapies. Ustekinumab binds with high affinity and specificity to the p40 protein subunit of IL-12 and IL-23. By this, it prevents IL-12 and IL-23 contributions to immune cell activation, such as intracellular signaling and cytokines’ secretion, which are relevant to psoriasis pathology. Ustekinumab was approved by the FDA for moderate-to-severe psoriatic patients in September 2009. Subsequently, it received approval in Canada and Europe for the same indication. In addition, on September 2013, the FDA and the European Commission have approved the use of ustekinumab for the treatment of psoriatic arthritis. Efficacy and safety of ustekinumab on patients with moderate-to-severe psoriasis were evaluated in four randomized clinical trials: a phase II placebo-controlled study, two phase III studies (PHOENIX 1 and 2), and a phase III comparator-controlled study (ACCEPT). Ustekinumab was evaluated in patients with psoriatic arthritis initially in a 36-week randomized, placebo-controlled, crossover trial and the results was confirmed in two randomized, placebo-controlled Phase III trials, PSUMMIT1 and PSUMMIT2. These trials led to the approval and post-trial use of ustekinumab, as an available therapeutic option of the daily clinical practice. Keywords: ustekinumab; psoriasis; psoriatic arthritis; tumor necrosis factor-α inhibitor; clinical trials. Received: June 5, 2014; Accepted: October 9, 2014; Published: January 19, 2015 Corresponding Author: Marina Talamonti, MD, Department of Dermatology, University of Rome Tor Vergata, Viale Oxford, 81, 00133 Rome, Italy. E-mail: marinatalamonti@libero.it .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".