What side effects are associated with this type of intervention?

The most common treatments for Polymyalgia Rheumatica (PMR) include glucocorticoids and IL-17A inhibitors like Secukinumab. Glucocorticoids can cause side effects such as weight gain, osteoporosis, hypertension, diabetes, and increased risk of infections. IL-17A inhibitors, such as Secukinumab, may lead to side effects including upper respiratory infections, headache, and injection site reactions. Both treatment types require careful monitoring to manage and mitigate these potential adverse effects.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved IL-17A inhibitors like Secukinumab for the treatment of Polymyalgia Rheumatica (PMR). The standard treatment for PMR typically involves corticosteroids such as prednisone to reduce inflammation and manage symptoms. Other biologic agents, including those targeting different inflammatory pathways, are being studied for their potential use in PMR, but IL-17A inhibitors have not yet been approved for this condition.

What other types of research exist?

Promising novel alternatives to Secukinumab for Polymyalgia Rheumatica patients include Janus kinase (JAK) inhibitors such as tofacitinib, baricitinib, and upadacitinib. These agents have shown efficacy in various inflammatory conditions and are being explored for PMR treatment. Additionally, IL-6 inhibitors like tocilizumab may also be considered, given their role in managing inflammatory diseases.

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Monoclonal Antibodies

Secukinumab for Polymyalgia Rheumatica (REPLENISH Trial)

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant, non-lactating female participants at least 50 years of age

Participants must have a history of being treated for at least 8 consecutive weeks with prednisone (≥ 10 mg/day or equivalent) at any time prior to screening

Must not have

Evidence of GCA as indicated by typical (cranial) symptoms

Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests secukinumab injections for adults with relapsed Polymyalgia Rheumatica (PMR). The treatment aims to reduce inflammation by calming the immune system. Researchers will compare the effectiveness and safety of secukinumab over a period of time. Secukinumab has been shown to improve signs and symptoms in various inflammatory conditions such as ankylosing spondylitis and psoriatic arthritis in multiple clinical trials.

Who is the study for?

Adults over 50 with Polymyalgia Rheumatica (PMR) who've relapsed after trying to reduce their prednisone dosage can join. They must have been on prednisone for at least 8 weeks before and had a PMR flare-up while tapering off the drug within the last 12 weeks.

What is being tested?

The trial is testing Secukinumab, given as an injection under the skin, in two different doses (300 mg and 150 mg), compared to a placebo. All treatments are combined with a decreasing dose of prednisone over half a year.

What are the potential side effects?

Secukinumab may cause infections, allergic reactions at the injection site, headache, high blood pressure, fungal infections in mouth or throat, diarrhea, runny nose or sore throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man or a woman not pregnant or breastfeeding, and I am 50 years old or older.

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I have been treated with prednisone or a similar medication for at least 8 weeks before.

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I had a PMR flare-up while reducing my prednisone dose to 5 mg/day or more in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms typical of Giant Cell Arteritis.

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I have a condition like rheumatoid arthritis or lupus.

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I have or had a nerve or muscle disease.

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My underactive thyroid is not properly managed.

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I have been treated with drugs targeting IL-17 for my condition.

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I haven't taken tocilizumab or similar drugs recently or they didn't work for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving sustained remission

Secondary study objectives

Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up

Change in FACIT-Fatigue Score

Change in HAQ-DI score

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Secukinumab 300 mgExperimental Treatment1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group II: Secukinumab 150 mgExperimental Treatment1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group III: Placebo to secukinumabPlacebo Group1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Secukinumab 300 mg

2016

Completed Phase 4

~480

Secukinumab 150 mg

2016

Completed Phase 4

~260

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Polymyalgia Rheumatica (PMR) is commonly treated with glucocorticoids, which reduce inflammation by suppressing the immune system. However, long-term use of glucocorticoids can lead to significant side effects. Secukinumab, an IL-17A inhibitor, is being studied as an alternative treatment. IL-17A plays a role in the inflammatory process, and inhibiting it can reduce inflammation and potentially decrease the need for glucocorticoids. This is important for PMR patients as it offers a targeted approach to managing inflammation with potentially fewer side effects compared to long-term glucocorticoid use.

Reviewing the Pathophysiology Behind the Advances in the Management of Giant Cell Arteritis.Tocilizumab (Actemra).Macrophage Activation Syndrome.