P1, N=76, Recruiting, Daewoong Pharmaceutical Co. LTD.

P3, N=315, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Active, not recruiting | N=210 --> 315 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025

Anti-MDA5-positive DM was diagnosed, and she was treated with triple therapy combined with tofacitinib because poor prognostic factors existed...Subsequent antibiotic therapy resolved both the cutaneous and pulmonary lesions. This case highlights the importance of considering bacteremia and performing blood cultures when DM-related skin ulcers resist conventional treatments, even without fever during immunosuppressive therapy.

P3, N=438, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Jun 2025

P1, N=32, Completed, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Completed | Trial completion date: Oct 2024 --> Jun 2024

P2, N=91, Completed, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Active, not recruiting --> Completed

Regardless of baseline BMI category, efficacy was greater with tofacitinib versus placebo in patients with AS, and no treatment effect differences between categories were observed, with exceptions for BMI ≥ 30 kg/m2 (more active/treatment-refractory disease and a smaller sample size). Overall, tofacitinib safety was generally comparable across categories; however, AE/SAE rates with tofacitinib were higher in the BMI < 25 kg/m2 category (which had more current smokers). This post hoc analysis demonstrates that tofacitinib can be considered as a treatment option for AS, regardless of baseline BMI category; however, interpretation was limited by small sample sizes and differences in sample sizes and baseline characteristics across categories.

In turn, the results indicate that the anti-asthmatic action induced by the studied agents is not mediated by the generation of forkhead box protein 3-expressing CD4+ regulatory T cells. Clinical implication of the the results suggest that MMF and TFB may exert anti-asthmatic action, and thus they may be considered therapeutic options for the treatment of allergic asthma cases resistant to conventional/existing treatment.

P4, N=104, Recruiting, Charite University, Berlin, Germany | Not yet recruiting --> Recruiting | Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Nov 2025 --> Mar 2025

P2, N=2, Terminated, Khashayar Esfahani | N=10 --> 2 | Trial completion date: Sep 2025 --> Jan 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Jan 2024; sponsor decision, due to low recruitment rate

P2, N=20, Not yet recruiting, M.D. Anderson Cancer Center

Furthermore, significantly lower tumor necrosis factor-α (TNFα), IL-6, and IL-1β levels (P < 0.05) were detected by enzyme-linked immunosorbent assay (ELISA) in homogenates of the joints treated with MDTs than in untreated arthritic joints. In conclusion, this study proposed effective MDTs that could deliver tofacitinib directly to inflamed joints possibly by targeting the macrophages circulating in the proximity of the site of inflammation.

Of these, 29% did not have features consistent with anti-MDA5 disease. However, when present, MDA5 disease is severe with a high mortality.

P1, N=12, Not yet recruiting, Beijing Tiantan Hospital

P3, N=600, Recruiting, Pfizer | Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2025 --> Apr 2026

P=N/A, N=10, Not yet recruiting, Peking University Hospital of Stomatology; Peking University Hospital of Stomatology

In concordance with studies of background risk, AEs were more common in patients with CV risk enrichment, particularly those aged ≥ 65 years. Tofacitinib effectiveness/persistence were generally similar regardless of CV risk enrichment. These findings support individualised treatment benefit-risk assessment, including CV assessment/management, to optimise RA outcomes.

Our findings suggest that tofacitinib may reduce the risk of all-cause mortality in patients with anti-MDA5 antibody-positive DM-ILD without an increased risk of additional infections. PROSPERO: CRD42023445427; https://www.crd.york.ac.uk/prospero/.

P3, N=843, Completed, Astellas Pharma Inc | Phase classification: P2b --> P3

Furthermore, the elevated production of inflammatory cytokines observed in 3CK-treated hiPSC-COs was attenuated by treatment with tofacitinib. Our UC model will be an essential tool to understand its pathologic mechanisms and identify effective therapeutic approaches.

P1, N=15, Completed, Astellas Pharma Inc | Phase classification: P1b --> P1

P2, N=281, Completed, Astellas Pharma Inc | Phase classification: P2b --> P2

P2, N=289, Completed, Astellas Pharma Global Development, Inc. | Phase classification: P2b --> P2

P2, N=379, Completed, Astellas Pharma Inc | Phase classification: P2b --> P2

P2, N=124, Completed, Astellas Pharma Inc | Phase classification: P2a --> P2

P=N/A, N=850, Recruiting, Pfizer | N=450 --> 850

P1, N=13, Completed, TWi Biotechnology, Inc. | Recruiting --> Completed

P=N/A, N=39, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=850 --> 39

P=N/A, N=116, Completed, Pfizer | Recruiting --> Completed | N=500 --> 116

P=N/A, N=20000, Active, not recruiting, Pfizer | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024

She was treated with rituximab along with oral glucocorticoid and other supportive treatment to which she didn't respond adequately. So, we added tofacitinib as adjuvant therapy in our patient. Post-six months of commencement of adjuvant tofacitinib, patient experienced remarkable improvement in cutaneous features as well as in pulmonary fibrosis.

P4, N=75, Not yet recruiting, Post Graduate Institute of Medical Education and Research, Chandigarh

P=N/A, N=18, Terminated, Pfizer | N=60 --> 18 | Trial completion date: Oct 2024 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Apr 2024; Study was terminated due to difficulty in enrolling targeted number of participants. There were no safety and/or efficacy concerns in the decision to stop enrollment.

P=N/A, N=150, Recruiting, Pfizer | N=280 --> 150

Moreover, peficitinib decreased renal protein levels and gene expression of the pro-inflammatory cytokines; interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α) and interferon gamma (IFN-γ). These findings suggest that peficitinib is helpful in halting AKI progression into chronic kidney disease through modulating JAK/STAT3 dependent inflammatory pathways and growth factors involved in normal glomerular function.

To our knowledge, this is the first report of MDA5-DM complicated by breast cancer, as well as the first case of JAK inhibitor use for MDA5-DM with cancer. For curative treatment of MD5-DM with RP-ILD, if comorbid cancers are found, collaboration with oncologists to balance the efficacy and adverse events of MDA5-DM with RP-ILD therapy is essential in determining the appropriate type and timing of treatment, which could lead to a favorable outcome.

P2, N=15, Recruiting, Aclaris Therapeutics, Inc.

P1, N=12, Completed, Pfizer | Active, not recruiting --> Completed

Subsequent development led to the creation of nine potent molecules, with derivatives 43 and 46 showing exceptional affinity upon evaluation through molecular dynamics simulation and MM/GBSA calculations over 300 nanoseconds, comparable to tofacitinib, an approved RA drug. However, compounds L21 and L46 demonstrated stable performance, suggesting their effectiveness in treating rheumatoid arthritis and other autoimmune conditions associated with JAK3 inhibition.

T-C@HP also alleviates colitis by regulating the colonic inflammatory microenvironment through multiple processes, including the modulation of apoptosis, macrophage polarization, tight junction, mucus layer, and intestinal flora. Complemented by satisfactory anti-inflammatory and biosafety results, this nanoplatform represents a promising, effective, and safe treatment option for colitis patients.

In this study, novel pyrimidine compounds, BY4003 and BY4008, were synthesized to target the JAK3/STAT3 signaling pathway, and their therapeutic efficacy and mechanisms of action were evaluated and compared with Tofacitinib in U251, A172, LN428 and patient-derived glioblastoma cells...Results showed decreased expression of STAT3-associated proteins, including p-STAT3, CyclinD1, and Bcl-2, and increased expression of Bax, a pro-apoptotic protein, as well as significant down-regulation of STAT3 and STAT3-related genes. These findings suggested that BY4003 and BY4008 could inhibit GBM growth by suppressing the JAK3/STAT3 signaling pathway, providing valuable insights into the therapeutic development of GBM.

P=N/A, N=450, Recruiting, Pfizer | Not yet recruiting --> Recruiting