A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

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• Arthritis, Psoriatic 579

Arthritis, Psoriatic

579 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's enrollment of 250 is above the median of 135 across 322 interventional studies indexed under Arthritis, Psoriatic.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Ixekizumab - PsO With no Active PsA

  Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received: * Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20

  Drug: Ixekizumab

• Experimental
  Ixekizumab - Active PsA

  Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20 Participants with active PsA without moderate to severe PsO received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by * Ixekizumab 80 mg SC injection Q4W at Week 4, 8, 12, 16, and 20.

  Drug: Ixekizumab

Interventions

• DrugIxekizumab

  Administered SC

  Also known as: LY2439821

Primary outcomes

1. Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24

   * An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect. * TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period.

   Time frame: Week 0 to Week 24

Secondary outcomes

1. PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12

   Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.

   Time frame: Week 12

2. PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal)

   The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here.

   Time frame: Week 12

3. Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24

   The ACR 20 is defined as: * 20% improvement from baseline in both tender joint count (68 counts) and swollen joint count (66 counts) * 20% improvements improvement in at least three of the following five items: Patient's global assessment of arthritis pain (measured on a 100-mm visual analog scale \[VAS\]); Patient's global assessment of disease activity (measured on a 100-mm VAS); Physician's global assessment of disease activity (measured on a 100-mm VAS); Patient's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI); Acute-phase reactant as measured by high-sensitivity C-reactive protein (hs-CRP) assay.

   Time frame: Week 24

Baseline characteristics

Study documents

• Study protocol · Feb 14, 2023
• Statistical analysis plan · Nov 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr