Psoriatic Arthritis

• CLINICAL_TRIALS trial_result · 2022-11-14
  Clinical Trial Update: Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis [Phase 3]

  Phase 3 trial investigating how tapering immunosuppressants affects maintaining minimal disease activity in adults with psoriatic arthritis.

• CLINICAL_TRIALS trial_result · 2022-07-26
  Clinical Trial Update: Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement [Phase 2]

  Phase 2 trial evaluating tofacitinib for reducing spinal inflammation in psoriatic arthritis with axial involvement.

• FDA approval · 2022-07-18
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz's supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ. The approval covers multiple inflammatory …

• FDA approval · 2022-06-17
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) from Immunex Corporation, resulting in labeling changes for the product.…

• CLINICAL_TRIALS trial_result · 2022-05-16
  Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy [Phase 3]

  Phase 3 trial evaluating filgotinib in biologic DMARD-naive active psoriatic arthritis was terminated with results posted.

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• CLINICAL_TRIALS trial_result · 2022-03-18
  Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy [Phase 3]

  Phase 3 trial evaluating filgotinib in active psoriatic arthritis patients intolerant or inadequate response to biologic DMARD therapy was t…

• CLINICAL_TRIALS trial_result · 2022-03-11
  Clinical Trial Update: MYL-1401A Efficacy and Safety Comparability Study to Humira® [Phase 3]

  Phase 3 trial comparing MYL-1401A to Humira for psoriasis, arthritis, and psoriatic arthritis has completed.

• CLINICAL_TRIALS trial_result · 2022-03-04
  Clinical Trial Update: A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis [Phase 3]

  Phase 3 trial evaluating the efficacy and safety of Bimekizumab in adults with moderate to severe chronic plaque psoriasis, using an initial…

• CLINICAL_TRIALS trial_result · 2022-03-02
  Clinical Trial Update: A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) [Phase 3]

  Phase 3 trial comparing risankizumab to placebo in active psoriatic arthritis, including participants with prior inadequate response or into…

• CLINICAL_TRIALS trial_result · 2022-03-02
  Clinical Trial Update: A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) [Phase 3]

  A Phase 3 trial comparing risankizumab to placebo in active psoriatic arthritis, including patients with prior inadequate response or intole…

• CLINICAL_TRIALS trial_result · 2022-03-02
  Clinical Trial Update: Impact of Concomitant MTX on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active PsA [Phase 3]

  Phase 3 clinical trial update examining how concomitant methotrexate affects the efficacy, safety, and adherence of ustekinumab in active ps…

• CLINICAL_TRIALS trial_result · 2022-02-24
  Clinical Trial Update: A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy [Phase 3]

  Phase 3 trial comparing risankizumab to placebo in adults with active psoriatic arthritis who had inadequate response or intolerance to at l…

• CLINICAL_TRIALS trial_result · 2022-02-03
  Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis [Phase 3]

  Phase 3 study evaluating the efficacy and safety of bimekizumab versus placebo and an active comparator in adults with moderate-to-severe ch…

• CLINICAL_TRIALS trial_result · 2022-01-28
  Clinical Trial Update: EBIO - Enthesitis Biopsy Study [Phase 4]

  Phase 4 clinical trial update for EBIO focusing on enthesitis biopsy in psoriatic arthritis patients.

• CLINICAL_TRIALS trial_result · 2022-01-25
  Clinical Trial Update: A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) [Phase 3]

  Phase 3 clinical trial comparing Upadacitinib to placebo and to Adalimumab in psoriatic arthritis patients with inadequate response to non-b…

• CLINICAL_TRIALS trial_result · 2022-01-25
  Clinical Trial Update: A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug [Phase 3]

  A Phase 3 trial comparing upadacitinib to placebo in patients with active psoriatic arthritis who had an inadequate response to at least one…

• CLINICAL_TRIALS trial_result · 2022-01-06
  Clinical Trial Update: Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging [Phase 4]

  A Phase 4 clinical trial evaluating etanercept therapy for nails psoriasis monitoring using noninvasive imaging.

• FDA approval · 2021-12-17
  FDA Approved: YUSIMRY — Original Application (Coherus BioSciences Inc)

  FDA approved YUSIMRY (adalimumab-aqvh) from Coherus BioSciences in an original biologics license application, likely as a biosimilar to adal…

• FDA approval · 2021-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc. The submission status …

• FDA approval · 2021-12-14
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in updated …

• CLINICAL_TRIALS trial_result · 2021-12-07
  Clinical Trial Update: Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA) [Phase 3]

  Phase 3 trial update evaluating Power Doppler Ultrasound to measure response to secukinumab in active psoriatic arthritis; results posted.

• FDA approval · 2021-12-02
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) from Pfizer Laboratories Div Pfizer Inc. The approval authorizes the ex…

• CLINICAL_TRIALS trial_result · 2021-11-23
  Clinical Trial Update: Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) [Phase 2]

  Phase 2 trial assessing safety and effectiveness of the Live Zoster Vaccine in patients using anti-TNF therapy for inflammatory diseases, wi…

• CLINICAL_TRIALS trial_result · 2021-11-05
  Clinical Trial Update: Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy [Phase 2]

  Phase 2 dose-ranging trial of BMS-945429 in psoriatic arthritis patients not responding to NSAIDs or non-biologic DMARDs has completed with …

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.