Effects of ritlecitinib: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Key Findings

Ritlecitinib is a novel JAK3/TEC inhibitor that has shown promise in treating various autoimmune conditions. 4 , 12 , 16

In patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate, ritlecitinib demonstrated efficacy and safety compared to placebo. 4

Ritlecitinib has shown potential in treating alopecia areata (AA), with several clinical trials and smaller studies demonstrating hair regrowth and remission. 12 , 7

Ritlecitinib is a small molecule that covalently and irreversibly inhibits Janus kinase 3 (JAK3) and the TEC family of kinases. In a Phase 1 study, ritlecitinib demonstrated target occupancy and functional inhibition of JAK3 and TEC family kinases. 5

Ritlecitinib has shown promise in treating active nonsegmental vitiligo in a randomized phase 2b clinical trial. 16

Benefits and Risks

Benefit Summary

Ritlecitinib has shown potential as a treatment for various autoimmune diseases, including rheumatoid arthritis, alopecia areata, and vitiligo. 4 , 12 , 16

Ritlecitinib may be particularly effective in treating rheumatoid arthritis patients who have not responded well to methotrexate. 4

Ritlecitinib has shown promise in inducing hair regrowth and remission in patients with alopecia areata, even those who have not responded to conventional treatments. 12

Ritlecitinib may have a better side effect profile compared to other JAK inhibitors. 15

Risk Summary

Ritlecitinib is generally considered safe and well-tolerated. 5 , 6

Common adverse effects include headache, nasopharyngitis, and upper respiratory tract infection. 8

Ritlecitinib may affect liver and kidney function. 6

Ritlecitinib should be avoided during pregnancy and breastfeeding. 5

Ritlecitinib is an immunosuppressant, which can increase the risk of infections. 11

The long-term safety of ritlecitinib has not yet been fully evaluated. 11

Comparison of Studies

Commonalities

The studies suggest that ritlecitinib, by selectively inhibiting JAK3 and TEC family kinases, can effectively target inflammatory signaling pathways associated with autoimmune diseases. 5

All studies demonstrate that ritlecitinib holds potential as a therapeutic option for different autoimmune diseases. 4 , 12 , 16

Differences

The studies differ in the specific autoimmune conditions they focus on and in their methodologies for evaluating ritlecitinib's efficacy and safety. 4 , 12 , 16

The study designs and sample sizes also vary across these studies. 4 , 12 , 16

Consistency and Discrepancies in Results

The studies consistently suggest that ritlecitinib might be beneficial for treating autoimmune conditions like rheumatoid arthritis, alopecia areata, and vitiligo. 4 , 12 , 16

However, direct comparisons of these studies are challenging due to differences in the specific conditions, evaluation methods, study designs, and sample sizes. 4 , 12 , 16

Additionally, these studies have not assessed the long-term efficacy and safety of ritlecitinib. 11

Considerations for Real-World Application

Ritlecitinib is not yet approved for the treatment of rheumatoid arthritis, alopecia areata, or vitiligo. 4 , 12 , 16

Ritlecitinib should be used only under the supervision of a healthcare professional. 5

Ritlecitinib should be avoided during pregnancy and breastfeeding. 5

Ritlecitinib is an immunosuppressant, which can increase the risk of infections. 11

Limitations of Current Research

The research on ritlecitinib is still limited in scope. 4 , 12 , 16

Studies on the long-term efficacy and safety of ritlecitinib are still lacking. 11

Research on the efficacy of ritlecitinib in other autoimmune conditions needs to be conducted. 5

Future Research Directions

Further research is necessary to evaluate the long-term efficacy and safety of ritlecitinib. 11

Research on the efficacy of ritlecitinib in other autoimmune diseases should be conducted. 5

Research is needed to determine the optimal dosage and duration of treatment with ritlecitinib. 6

Studies evaluating combination therapies with ritlecitinib and other medications should be conducted. 5

Conclusion

Ritlecitinib is a promising novel JAK3/TEC inhibitor with potential for treating various autoimmune diseases. 5

Ritlecitinib has shown promise in treating rheumatoid arthritis, alopecia areata, and vitiligo, but further research is needed to confirm its efficacy and safety. 4 , 12 , 16

It is important to use ritlecitinib only under the supervision of a healthcare professional and to be aware of the potential risks and benefits of the medication. 5

Literature analysis of 16 papers
Positive Content
16
Neutral Content
0
Negative Content
0
Article Type
5
0
2
6
15
1.

A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder.

Author: SimpsonGeorge M, MahmoudRamy A, LasserRobert A, KujawaMary, BossieCynthia A, TurkozIbrahim, RodriguezSteven, GharabawiGeorges M

Improved functioning
Low relapse

Long-acting risperidone was associated with low relapse and rehospitalization rates in patients with schizophrenia or schizoaffective disorder. Doses of 25 to 50 mg were appropriate for long-term treatment.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Improvements in immune/melanocyte biomarkers with JAK3/TEC family kinase inhibitor ritlecitinib in vitiligo.

Author: Guttman-YasskyEmma, Del DucaEster, Da RosaJoel Correa, BarJonathan, EzzedineKhaled, YeZhan, HeWen, HydeCraig, Hassan-ZahraeeMina, YamaguchiYuji, PeevaElena

Vitiligo treatment

This substudy of a randomized, double-blind, placebo-controlled phase 2b trial of ritlecitinib, a JAK3/TEC family kinase inhibitor, found that treatment significantly downregulated proinflammatory biomarkers and increased melanocyte products in the skin and blood of participants with nonsegmental vitiligo (NSV).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata.

Author: Ramírez-MarínHassiel Aurelio, TostiAntonella

Alopecia areata treatment
Hair regrowth
JAK3/TEC inhibition
Drug interactions
Long-term effects
Potential side effects

Ritlecitinib, a selective JAK3/TEC kinase inhibitor, is a promising treatment for alopecia areata, with a significant proportion of patients reaching SALT 20 after six months of therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate.

Author: RobinsonMichael F, DamjanovNemanja, StamenkovicBojana, RadunovicGoran, KivitzAlan, CoxLori, ManukyanZorayr, BanfieldChristopher, SaundersMichael, ChandraDeepa, VincentMichael S, MancusoJessica, PeevaElena, BeebeJean S

Rheumatoid arthritis treatment
Infections
Skin disorders

PF-06651600 (ritlecitinib), an oral JAK3/TEC inhibitor, was associated with significant improvements in rheumatoid arthritis disease activity and was generally well-tolerated in an 8-week study.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Target Occupancy and Functional Inhibition of JAK3 and TEC Family Kinases by Ritlecitinib in Healthy Adults: An Open-Label, Phase 1 Study.

Author: MartinDavid A, TelliezJean-Baptiste, Pleasic-WilliamsSusan, ZhangYing, TierneyBrendan, BlatnikMatthew, GaleJeremy D, BanfieldChris, ZhouYifan, LejeuneAlexandre, ZwillichSamuel H, StevensErin, TiwariNeeraj, KierasElizabeth, KaranamAshwin

JAK3 inhibition
TEC kinase inhibition

This phase 1 clinical trial investigates the effects of ritlecitinib, a new drug in development, on JAK3 and TEC family kinases. The study found that ritlecitinib effectively inhibited both JAK3 and TEC kinases, suggesting potential benefits for treating inflammatory and autoimmune diseases.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics.

Author: PurohitVivek, HuhYeamin, WojciechowskiJessica, PlotkaAnna, SaltsStephanie, AntinewJeremias, DimitrovaAngela, NicholasTimothy

Ritlecitinib is a JAK3 inhibitor with a favorable safety profile. Two phase I studies investigated its pharmacokinetics and safety in individuals with hepatic and renal impairment. The results suggest that dose adjustments are not necessary for patients with renal impairment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors.

Author: GuptaAditya K, WangTong, Polla RaviShruthi, BamimoreMary A, PiguetVincent, TostiAntonella

Alopecia areata treatment
Conventional systemic agent side effects
Systemic steroids side effects

This systematic review evaluated the efficacy and safety of newer agents for the treatment of alopecia areata (AA), including JAK inhibitors, biologics, and PDE-4 inhibitors. Oral JAK inhibitors showed promising results, while PDE-4 inhibitors and biologics appeared to have limited efficacy.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Ritlecitinib: an investigational drug for the treatment of moderate to severe alopecia areata.

Author: EismanSamantha, SinclairRodney

Potential therapy

Alopecia areata (AA) is a challenging autoimmune disease with limited treatment options and no cure. Ritlecitinib, a novel oral JAK3-selective inhibitor, is being investigated as a potential treatment for AA, offering hope for a safe and effective therapy.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

10.

JAK inhibitors in dermatology: the road travelled and path ahead, a narrative review.

Author: MuddebihalAishwarya, KhuranaAnanta, SardanaKabir

Dermatoses treatment

Many skin diseases mediated by cytokines rely on the JAK STAT pathway for signaling. JAK inhibitors have shown promise in treating these conditions, including alopecia areata, vitiligo, atopic dermatitis, and psoriasis.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib.

Author: WinnetteR, BanerjeeA, SikiricaV, PeevaE, WyrwichK

Alopecia areata treatment

This phase 2a trial investigated the safety and efficacy of ritlecitinib and brepocitinib in adults with alopecia areata, highlighting the need for further research on correlations between clinician-assessed hair loss and patient-reported outcomes.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

A plain language summary on ritlecitinib treatment for adults and adolescents with alopecia areata.

Author: KingBrett, ZhangXingqi, HarchaWalter Gubelin, SzepietowskiJacek C, ShapiroJerry, LyndeCharles, MesinkovskaNatasha A, ZwillichSamuel H, NapatalungLynne, WajsbrotDalia, FayyadRana, FreymanAmy, MitraDebanjali, PurohitVivek, SinclairRodney, WolkRobert

Alopecia areata treatment

The ALLEGRO phase 2b/3 clinical trial showed that ritlecitinib, a medicine taken as a pill every day, by mouth, is effective and safe for treating people with severe alopecia areata (AA). Ritlecitinib blocks processes that are known to play a role in causing hair loss in patients with AA.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway.

Author: SardanaKabir, BathulaSavitha, KhuranaAnanta

Alopecia areata treatment

Alopecia areata (AA) is an immune-mediated condition that causes hair loss. Janus kinase (JAK) inhibitors are emerging as a promising treatment for AA, but the ideal JAK inhibitor is not yet established. This review discusses the role of the JAK/STAT pathway in AA and the potential benefits and risks of various JAK inhibitors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.

Author: EzzedineKhaled, PeevaElena, YamaguchiYuji, CoxLori Ann, BanerjeeAnindita, HanGeorge, HamzaviIltefat, GanesanAnand K, PicardoMauro, ThaçiDiamant, HarrisJohn E, BaeJung Min, TsukamotoKatsuhiko, SinclairRodney, PandyaAmit G, SloanAbigail, YuDahong, GandhiKavita, VincentMichael S, KingBrett

Improved vitiligo
Well tolerated

This phase 2b trial evaluated the efficacy and safety of ritlecitinib, an oral JAK3/TEC inhibitor, in patients with active nonsegmental vitiligo. Ritlecitinib was effective in reducing vitiligo severity, with significant differences observed compared to placebo for the 50 mg dose groups, both with and without a loading dose, and the 30 mg group. The drug was well tolerated, with no dose-dependent trends in adverse events.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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