Tofacitinib efficacy, patient‐reported outcomes and safety in patients with psoriasis and a medical history of psoriatic arthritis: Pooled analysis of two Phase <scp>III</scp> studies
Bibliographic record
Abstract
Tofacitinib efficacy, patient-reported outcomes and safety in patients with psoriasis and a medical history of psoriatic arthritis: Pooled analysis of two Phase III studiesDear Editor, Approximately 30% of patients with psoriasis have psoriatic arthritis (PsA). 1 Patients with PsA with joint/skin symptoms have worse disease activity/patient-reported outcomes (PROs) than patients with only joint symptoms.2 Tofacitinib is an oral Janus kinase inhibitor for treatment of PsA.Using pooled data from two global/52-week/Phase III studies, OPT Pivotal 1 and 2 [NCT01276639/NCT01309737], 3 this post hoc analysis examined the efficacy/PROs/safety of tofacitinib in patients with moderate to severe plaque psoriasis and history of PsA, and explored the role of itch/joint pain/morning stiffness in reducing depressive symptoms.In OPT Pivotal 1 and 2, patients were randomized to tofacitinib 5 or 10 mg twice daily (BID) or placebo.At Week 16, placebotreated patients were re-randomized to tofacitinib 5 or 10 mg BID to Week 52.Efficacy outcomes, to Week 52, included proportions of patients achieving Psoriasis Area and Severity Index (PASI)75, PASI90, and those with Itch Severity Item (ISI) score improvement from baseline >2 and Hospital Anxiety and Depression Scale Depression (HADS-D) subscale score <8.Change from baseline in ISI score, joint pain assessment (JPA) score and morning stiffness on JPA score were also measured to Week 52.Mediation modelling examined tofacitinib's effect on depressive symptoms with ISI/JPA/morning stiffness as mediators.Safety outcomes included frequency of adverse events (AEs) and serious AEs (SAEs), frequency and incidence rates of AEs of special interest (AESI), discontinuation due to AEs and deaths.Of 1859 patients with psoriasis, 430 (23.1%) had PsA history.At Week 16, PASI75/PASI90 response rates, ISI score improvement from baseline >2, and change from baseline in ISI/JPA/morning stiffness were greater with tofacitinib 5 and 10 mg BID versus placebo (Figure 1a-f).Altogether, 45.2% and 46.5% of patients receiving tofacitinib 5 and 10 mg BID, respectively, had a HADS-D subscale score <8 at Week 16 (Figure 1g).Efficacy outcomes were generally maintained to Week 52.Mediation modelling analysis
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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 | 0.020 | 0.022 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.024 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".