At the time, Actemra (tocilizumab) was FDA approved for GCA but not PMR. My rheumatologist wanted me to try Actemra for PMR since he was reading the available research from the GIACTA trial.

The way my rheumatologist asked me was, "IF he could get it approved, would I be willing to try Actemra?" He made it sound like it would be hard to get it approved but he would make the effort and submit the paperwork that was needed.

I was interested in trying any biologic but I wasn't too excited about Actemra simply because I had never heard of it. No biologic was FDA approved for PMR at the time. The request was made but it didn't seem likely to be approved. The FDA doesn't control what doctors prescribe but doctors must follow the current "standards of care" for treating patients. If a medication isn't FDA approved for a condition it is considered to be "experimental."

Insurance companies don't usually pay for experimental treatments. Hospitals also follow a medication formulary. For expensive medications doctors need to justify why they want to give the medication to the patient if it isn't FDA approved for the condition being treated. This is because the hospital won't be reimbursed for the cost of the medication. Also, if the treatment causes harm to the patient, there are liability issues.

Every hospital has their own protocols for this situation but doctors are required to give justification if their treatment doesn't follow current standards of care. I wasn't involved in the decision making but I read the documentation that was put in my medical records. That was where my rheumatologist made the assertion that all other alternatives were tried and had failed.

I personally think my rheumatologist embellished my case but technically he was correct. There was some kind of medical panel that decided to approve his request. The recommendation by the medical panel was to follow the guidelines for treating a patient who had GCA. Since Actemra was an FDA approved biologic for GCA, they concluded Actemra "might work for PMR." It was essentially a "trial of one" to give me Actemra --- that was in 2018.

Last year Kevzara was FDA approved for PMR.

“With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”

Kevzara and Actemra block the IL-6 inflammation pathway that is implicated in both PMR and GCA. The criteria for allowing doctors to prescribe these biologics to treat PMR and GCA has now loosened considerably in the US since they are FDA approved. I think "long term dependence on steroids" is no longer applicable because many people seem to get Kevzara soon after being diagnosed with PMR.

Actemra still isn't FDA approved for PMR because the research seeking approval from the FDA hasn't been submitted. However, many people are being prescribed Actemra for GCA.

I just reread your question.

Simple answer ... yes my inflammation markers (CRP and ESR) were checked routinely. I don't recall any time when these biomarkers were not elevated. Prednisone decreased my biomarkers but rarely were they within the normal range. Actemra normalized my CRP and ESR. I was so surprised that I asked by rheumatologist if my CRP and ESR were "too low." These labs aren't reliable when a person is taking Actemra but my symptoms were also nil.

I still recall the day when I was on 30 mg of Prednisone. My rheumatologist was surprised when my CRP and ESR were STILL elevated and said I should take 35 mg. On 35 mg, my ESR and CRP were "mildly elevated." Multiple NSAIDs and DMARDs in addition to prednisone were tried but mildly elevated was the best I could ever achieve unless my prednisone dose was very high.

My biomarkers were used in conjunction with my symptoms. I would tell my rheumatologist when I experienced more pain when I tried to taper Prednisone lower. I think she believed me but she would check my inflammation markers just to see if my inflammation markers correlated with my symptoms. My CRP and ESR always correlated with my symptoms so my rheumatologist would say increasing my prednisone dose was warranted.

Actemra was approved on the basis that nothing else worked well. The other criteria was that I was "unable to taper off prednisone." All other alternatives including methotrexated had failed to normalized my inflammation markers but also for other reasons like infections and/or side effects.

Sometimes the failure of a medication was because of my intolerance for the medication. For example, methotrexate was working to control my PMR symptoms. I took methotrexate for more than a year. However, methotrextate over time increased my liver enzymes and was making me sick.

Does that answer your question any better?