Polymyalgia Rheumatica (PMR) - Clinical Trials

@johnbishop maybe title of this thread should be changed to "trials" in general - 2023 Are people interested to see these ? thank you

IF you are being treated at Yale - you be aware of Monique Hinchcliff, MD, MS-- there is an observation trial collecting blood from patients w/ PMR.

Another approach is anti IL-17 -- this trial has a US site in Spokane -
Secukinumab is a novel biologic agent specifically targeting interleukin-17 (IL-17) involved in a pathological process. It is a fully human monoclonal antibody.

ICH GCP
US Clinical Trials Registry
Clinical Trial NCT05767034
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) (REPLENISH)
April 12, 2023 updated by: Novartis Pharmaceuticals
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

@johnbishop maybe title of this thread should be changed to "trials" in general - 2023 Are people interested to see these ? thank you

IF you are being treated at Yale - you be aware of Monique Hinchcliff, MD, MS-- there is an observation trial collecting blood from patients w/ PMR.

Another approach is anti IL-17 -- this trial has a US site in Spokane -
Secukinumab is a novel biologic agent specifically targeting interleukin-17 (IL-17) involved in a pathological process. It is a fully human monoclonal antibody.

ICH GCP
US Clinical Trials Registry
Clinical Trial NCT05767034
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) (REPLENISH)
April 12, 2023 updated by: Novartis Pharmaceuticals
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

It is sad there aren't more treatment options for PMR/GCA. I was told many times that prednisone was the "only option" or the "best option." I took prednisone for more than 12 years for PMR. I asked many times if there was "any other options." The side effects of prednisone were taking a toll on me so I was willing to try anything else.

My rheumatologist had to get authorization to try Actemra (tocilizumab). An exception was made for me because Actemra isn't FDA approved for PMR but it is for GCA. My rheumatologist thought Actemra should work for PMR but didn't know if it would or not.

Actemra worked for me and I was able to taper off prednisone in a year. My rheumatologist thinks I'm better off on Actemra and I would agree.

@dadcue your story is amazing ! Are you aware that there is June 8 deadline for "patient perspective " for the upcoming ACR meeting ? rheumatology-dot- org. annual-meeting-patient-perspectives

What Is Eligible for Submission?
Submissions should meet one of the following criteria:

Address the question: “What adaptations did you and/or your healthcare team adopt to better care for your health?"
Describe how you became more engaged in healthcare.
Demonstrate an idea that was put into practice, and how the idea resulted in improved quality of life.

Thank-you but when I looked to find information I found the following:
"What Is Not Eligible for Submission?
Medication- or therapy-specific interventions will not be accepted."

The most significant thing that improved my quality of life was getting off prednisone. For 12 years, my life revolved around how much prednisone to take daily for PMR. My doctors helped me and encouraged me to keep trying to taper off prednisone yet they prescribed more prednisone than I needed. They didn't want me to ever run out. I'm grateful for the prednisone I received.

Actemra (tocilizumab) is an IL-6 receptor blocker that allowed me to get off prednisone. IL-6 is implicated in other autoimmune disorders so not just PMR/GCA. Now Kevzara is another IL-6 receptor blocker that was recently FDA approved for PMR.

I didn't think I would ever be able to get off prednisone. I tell my rheumatologist that taking prednisone was easy to do except for the long term side effects. Getting off prednisone was hard to do. I just wish that Actemra had been tried sooner because it made tapering off prednisone much easier. Actemra wasn't an option for me. Actemra was only FDA approved for GCA in 2017. I don't have GCA.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-specifically-treat-giant-cell-arteritis
It was my rheumatologist who thought Actemra should work for PMR and was willing to submit the authorization request to get it approved for me.

Thank-you but when I looked to find information I found the following:
"What Is Not Eligible for Submission?
Medication- or therapy-specific interventions will not be accepted."

The most significant thing that improved my quality of life was getting off prednisone. For 12 years, my life revolved around how much prednisone to take daily for PMR. My doctors helped me and encouraged me to keep trying to taper off prednisone yet they prescribed more prednisone than I needed. They didn't want me to ever run out. I'm grateful for the prednisone I received.

Actemra (tocilizumab) is an IL-6 receptor blocker that allowed me to get off prednisone. IL-6 is implicated in other autoimmune disorders so not just PMR/GCA. Now Kevzara is another IL-6 receptor blocker that was recently FDA approved for PMR.

I didn't think I would ever be able to get off prednisone. I tell my rheumatologist that taking prednisone was easy to do except for the long term side effects. Getting off prednisone was hard to do. I just wish that Actemra had been tried sooner because it made tapering off prednisone much easier. Actemra wasn't an option for me. Actemra was only FDA approved for GCA in 2017. I don't have GCA.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-specifically-treat-giant-cell-arteritis
It was my rheumatologist who thought Actemra should work for PMR and was willing to submit the authorization request to get it approved for me.

@johnbishop maybe title of this thread should be changed to "trials" in general - 2023 Are people interested to see these ? thank you

IF you are being treated at Yale - you be aware of Monique Hinchcliff, MD, MS-- there is an observation trial collecting blood from patients w/ PMR.

Another approach is anti IL-17 -- this trial has a US site in Spokane -
Secukinumab is a novel biologic agent specifically targeting interleukin-17 (IL-17) involved in a pathological process. It is a fully human monoclonal antibody.

ICH GCP
US Clinical Trials Registry
Clinical Trial NCT05767034
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) (REPLENISH)
April 12, 2023 updated by: Novartis Pharmaceuticals
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.