The answer to this question eluded me over the years with the wide variety of RA medicines I’ve taken. It came up this week when my wife asked it again after seeing me go through a particularly long and nasty flare. I reminded her that there is no cure, only treatments for RA. But it did raise my curiosity.
In an attempt to answer this question, I went back to the Orencia package insert[i] – those 20 page, 5 point font documents that every pharmaceutical company puts inside their medicines – to try to find some answers. Bristol Myers Squibb likes to include a copy of these inserts every time they send me something in the mail. Most people probably don’t read these lengthy, highly technical documents that include information on dosage, indications, administration, warnings, side effects, and efficacy. There are likely some regulatory guidelines from the government dictating their contents since at the bottom of the document it says, “The Instructions for Use has been approved by the U.S. Food and Drug Administration”. I dug through the insert until finding the section on clinical response – in other words, how well does it work?
Most clinical researchers use a variety of tools to gauge RA drug efficacy. The Health Assessment Questionnaire – Disability Index (HAQ-DI) which is a short version of the full HAQ is one such measure.[ii] Here’s a link to an online version of the HAQ. Many rheumatologists have their patients complete a HAQ and I remember doing this at my very first visit. Another commonly used tool to assess is the Disease Activity Score 28 or DAS28. It uses a count of the number of tender and swollen joints plus either a sedimentation rate (ESR) or c-reactive protein (CRP) blood test of inflammation. There is also an online version of DAS28 and an app for the iPhone. According to one site, “A DAS28 score higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.”[iii]
According to the online DAS28, I currently have high disease activity. One of the clinical studies on Orencia reported in the insert, “…a greater proportion of patients treated with ORENCIA plus methotrexate achieved a low level of disease activity as measured by a DAS28-CRP less than 2.6 at 12 months compared to those treated with methotrexate plus placebo.” The proportions reported were 41% of patients on Orencia/Methotrexate reached a DAS28 of less than 2.6 compared to 23% of placebo patients. That means that a larger proportion of patients, 59%, did not reach remission.
I’ve been on Orencia plus Arava for 11 months now and am not currently in that minority who reached remission. In fact, just the opposite has happened. It’s hard to tell at this point if this combination of disease modifying drugs is not working for me or it’s just a nasty flare induced by too much work in the past few months. But this will be a conversation my rheumy and I will have at our next visit in early December. I am very hesitant to try yet another treatment regimen as I’ve already been through a truck load. But my rheumy encouraged me there’s still hope and other treatments to try and her goal is remission.