Inflammation and Immunology Areas of Interest

Atopic Dermatitis (AD)

Research areas to be considered for Pfizer support include:

• Basic and clinical research to further characterize the various endotypes and phenotypes of patients with AD and their response to AD treatments
• Non-interventional studies (including epidemiological studies) related to disease burden, costs, comorbidities, and unmet need for new AD
• Translational research regarding the role of JAK/STAT pathway in AD and other skin diseases
• Clinical research into the use of JAK-1-inhibitors in AD and other inflammatory and non-inflammatory conditions (e.g. dermatologic diseases, including, but not limited to, eczematous disorders, connective tissue diseases, autoimmune blistering disorders, lichenoid eruptions, granulomatous dermatoses, neutrophilic dermatoses, cutaneous vasculitides, alopecia, scarring alopecias, prurigo nodularis, and chronic prurigo of unknown origin.)
• Optimization of healthcare delivery for patients with moderate-severe AD
• Studies evaluating abrocitinib in patients with skin of color

Out of Scope:

• Use in non-dermatologic conditions

Atopic Dermatitis (AD)

Research areas to be considered for Pfizer support include:

• Basic and clinical research to further characterize the various endotypes and phenotypes of Atopic Dermatitis (AD) and their response to AD treatments
• Translational research regarding the role of PDE-4 and/or JAK/STAT pathways in AD and other skin diseases
• Inflammatory and non-inflammatory diseases and conditions with potential benefit from topical application of a PDE-4-inhibitor
• Clinical research of PDE-4-inhibition in inflammatory skin diseases and conditions
• Real-world applications of crisaborole in AD management
• Non-interventional studies (including epidemiological studies) to examine comorbidities associated with AD, treatment patterns, disease burden, costs and unmet need for new treatments
• Studies evaluating crisaborole in patients with skin of color

Out of Scope:

• Use in non-dermatologic conditions

Gastroenterology

• Explore the role of S1P receptor modulation in the pathophysiology of UC, Crohn’s disease (CD), Eosinophilic esophagitis (EoE) and other gastrointestinal conditions
• Understand etrasimod’s mechanism of action in patients with gastrointestinal conditions including the role of S1P4 modulation and identification of therapeutic effects beyond lymphocyte egress
• Assess mechanistic association of S1P receptor modulation with adverse events of special interest
  • Effect on GIRK channels and impact on heart rate and AV conduction
  • Effect on lymphocyte subsets and relationship with immune surveillance/risk of infection and response to infection or vaccine response
  • Effects on endothelium and connection with hypertension, vascular permeability, macular oedema
• For patients treated with S1P receptor modulators, exploration for optimal markers (including clinical, endoscopic, histologic, genetics, and other measured markers) for patient stratification specific to disease activity, disease extent, and to monitor disease activity changes
• Characterize the role of the S1P-S1PR1 axis as the link between chronic intestinal inflammation and colitis-associated cancer
• Role of ultrasound in monitoring the response to treatment with S1P receptor modulators 
• S1P receptor modulator impact on the microbiome
• Evaluate efficacy and safety of S1P receptor modulators in IBD populations of special interest - elderly, patients with a history of malignancy, lines of therapy/previous drug exposure.
• Evaluate efficacy and safety of S1P receptor modulators in other gastrointestinal (GI) conditions such as pouchitis, proctitis, pancolitis, microscopic colitis, and checkpoint inhibitor induced colitis
• Evaluation of S1P receptor modulators in IBD as combination or sequenced treatment with immunosuppressants/advanced therapies
• Elucidate the role of S1P receptor modulators in extra-intestinal manifestations of IBD

Out of Scope:

• Studies that overlap with completed, ongoing and planned research
• Use in non-gastrointestinal conditions

Alopecia Areata (AA)

Research areas to be considered for Pfizer support include:

• Basic and clinical research to further characterize the various endotypes and phenotypes of patients with alopecia areata (AA) and vitiligo and their response to AA and vitiligo treatments
• Non-interventional studies (including epidemiological studies) related to disease burden, costs, comorbidities and unmet needs for AA and vitiligo.
• Translational research regarding the role of JAK3 and TEC inhibition pathways in AA, vitiligo, and other skin diseases
• Clinical research into the use of JAK3 and TEC inhibition in other skin diseases
• Studies evaluating ritlecitinib in patients with skin of color

Out of Scope:

• Use in non-dermatologic conditions

Rheumatoid Arthritis (RA):

• Mechanistic research into the role of JAK and TNF inhibition in relation to the occurrence of adverse events such as venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy
• Evaluate safety and efficacy in patients with comorbidities and special/sub-populations
• Treatment optimization: concomitant medication dose reduction or increase, dose optimization (including tapering after remission/ low disease activity, stop and retreat), switching (to/from biologic disease-modifying antirheumatic drugs (bDMARDs) / targeted synthetic disease-modifying antirheumatic drugs tsDMARDs)
• Evaluation of treat-to-target approach to achieve disease remission
• Effect on onset, sustainability, effectiveness, and health-related quality of life (especially pain and fatigue)
• Efficacy and safety in extra-articular manifestations
• Investigate efficacy and safety as monotherapy
• Evaluation of approaches for the management of viral infections or vaccinations in RA patients and treatment outcomes
• Explore imaging studies to further help characterize the response to treatment or to help predict long-term outcomes
• Evaluation of adherence to risk management interventions for comorbidities such hyperlipidemia, anticoagulants etc.

Out of Scope:

• Underpowered studies, or those that overlap with currently planned Phase 3b or Phase 4 or ongoing non-interventional studies (NIS)
• Combination with biologics/immunosuppressants

Ankylosing Spondylitis:

• Efficacy and safety of JAKi across axial spondyloarthritis spectrum of disease, different populations and across lines of therapy
• Evaluate clinical, biomarker and imaging predictors of response and non-response to treatment and adverse events
• Evaluate long-term safety and efficacy of the use of JAKi
• Assess treatment adherence and persistence of JAKi
• Characterize JAKi relative to other advanced treatments across clinical outcomes
• Understand efficacy/safety across patient populations including in patients with common comorbidities and different cardiovascular risk profiles
• Explore improvement in extra-musculoskeletal manifestations (uveitis, psoriasis, inflammatory bowel disease (IBD)) and peripheral disease
• Assess treatment scenarios such as non-steroidal anti-inflammatory drug (NSAID) sparing, treatment interruption/recapture or treatment switch (to/from NSAIDs/ bDMARDs / tsDMARDs)

Out of Scope:

• Underpowered studies, or those that overlap with completed, ongoing and planned research
• Combination with biologics/immunosuppressants

Psoriatic Arthritis (PsA):

• Efficacy and safety of JAKi across domains of disease, different populations and lines of therapy
• Characterize JAKi efficacy/safety relative to other advanced treatments across clinical outcomes referring to capturing efficacy /safety across the domains of PsA (peripheral arthritis, skin/nails, enthesitis, dactylitis and axial domain)
• Understand efficacy/safety across patient populations including in patients with common comorbidities and different cardiovascular risk profiles
• Study treatment adherence and persistence of JAKi
• Investigate the safety and efficacy of JAKi in the treatment of axial PsA
• Understand clinical, biomarker and imaging predictors of response and non-response to treatment and adverse events
• Assess treatment scenarios such as steroid sparing, treatment interruption/recapture or treatment switch (to/from conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/ bDMARDs / tsDMARDs)
• Explore improvement in extra-musculoskeletal manifestations (uveitis, IBD)

Out of Scope:

• Underpowered studies, or those that overlap with completed, ongoing and planned research
• Combination with biologics/immunosuppressants

Ulcerative Colitis:

• Disease management in ulcerative colitis (UC) using tofacitinib and new measures of efficacy (e.g., treat to target, measures of efficacy, development of new tools for patient reported outcomes (PRO) measurement using wearables/apps)
• Use of tofacitinib in:
  • Other inflammatory gastrointestinal conditions such as eosinophilic gastroenteritis and microscopic colitis
  • UC patients with history of cancer (efficacy and safety)
• Evaluation of the ability to restart tofacitinib therapy after interruption in patients with UC
• Tofacitinib monotherapy (without concomitant 5 aminosalicylic acids (ASA) or steroids)
• Strategies to improve adherence to therapies in UC and predictors of adherence
• Contextualization of VTE/ major adverse cardiovascular event (MACE)/Malignancies risk of Tofacitinib/JAKi in patients with UC
• Predictors of Adverse events (e.g., lipids elevation, MACE, non-melanoma skin cancer (NMSC), herpes zoster (HZ), serious infections, VTE)
• Predictors of disease severity
• Predictors of early response to tofacitinib using combination of biomarkers, patient-related outcomes and clinical assessments
• Mechanistic association of JAK inhibition with safety events of special interest
• Effects of vaccination on tofacitinib treatment
• Evaluation of onset of action across measures of effectiveness including PROs
• Effect of tofacitinib on extra intestinal manifestations (EIM)
• Tofacitinib safety in the context of
• Tofacitinib and steroid free remission, long term remission and maintenance of response
• Use of tofacitinib in checkpoint inhibitor/immunotherapy-induced colitis

Out of Scope:

• Underpowered studies, or those that overlap with completed, ongoing and planned research
• Combination with biologics/immunosuppressants