Tuesday, August 5, 2014

Medications 2014 edition #1 BIOLOGICALS

In the 2 years since I posted the last medication blog we've had some new options appear on the radar.

In this post I'm going to focus on the biologicals and newest meds.  I see a lot of posts in the Psoriatic support groups about what these meds are and which they should choose.  I'll try to explain what each med is and does in layman's terms, but the reality is that you usually don't have a lot of choice in which you will get prescribed.  It is always your right to decline a medications, but be ready to be added to the difficult patient category unless you can find a way to justify your decision and even then many Rheumatologists I have run across have a big of an ego (not always a bad thing) and could take your declination as questioning their oh so great judgement and still get you labeled as difficult.

I am addressing the meds that are approved for Psoriatic Arthritis in the USA by the FDA.  If you are in another country there may be other prescribing guidelines for your country, but many of these are approved in multiple countries.  Some such as Stelara has been having a harder time getting approval especially in countries that have socialized medicine.

So Here we go.

Enbrel:(Entanercept)

We'll start with an oldie but goodie.  Enbrel was approved for Psoriasis and Psoriatic Arthritis in 2004.  It was the first biological agent approved for Psoriatic disease.  This is the medication that our Psoriatic celebrity golf pro Phil Mickelson has been having success with for some years now.

Enbrel is called a biological because it is genetically engineered from human protein.  This means that a biological substance is used to make the medication.  It inhibits TNF-Alpha proteins by binding to them so that they can not bind or activate TNF receptors.  This function is a normal action in the immune system, but has been seen to be an overactive response in many autoimmune patients.  The over function of the immune system causes inflammation.  Because the medication is binding a part of your immune system it can lower your immune response so that you are less able to fight disease and infection.

Enbrel is given via subcutaneous injection.  This means you are going to be shooting a needle into your thigh, arm or belly fat.  Many people cringe at this idea, but it sounds a lot worse than it is.  Your rheumatologist should schedule with a training session for your first injection so that you can see how it is done and ask any questions you may have about the injection process.  My preference has always been belly fat, but that's a personal decision as to which area you choose to target.  The loading process for Enbrel is 2 shots a week for the first 12 weeks, and then you will do 1 shot a week.  There is some variation of dose based on your response after your Rheumatologist has evaluated you on the medication over several months, but after loading 1 shot a week is the typical dose.  You may also need to continue with a DMARD while taking Enbrel.

While you are on Enbrel you will need to have regular blood work to monitor your inflammation, white blood cell counts and liver function.  You will also need to have an annual TB screening including chest x ray.

Humira:(adalimumab)

Humira is also a subcutaneous injection medication (again with the shooting your own fat).  Humira is also made with human protein, and works in a similar way to Enbrel by binding to TNF Alpha proteins.  Though several of these medications have the same premise of binding the TNF Alpha there is a difference in the molecular makeup of each other these so that when one doesn't work another may.

Humira has 1 loading dose of 2 injection pens and then 1 week later you start the normal dosing cycle which is 1 injection pen every 2 weeks. Humira and Enbrel are usually the first strike biological meds most Rheumatologists go to for patients who are not responding adequately to DMARDs and anti inflammatory medications.  They have the longest protocol history with Psoriatic Patients(and other immune diseases) so they are medications that Rheumatologists have experience with and know what to expect for most people in terms of progression of improvement and side effects.

Remicade:(infliximab)

Remicade is yet another TNF-Alpha inhibitor.  This one however is given through an infusion.  This means that an IV line will be set up and the medication will be dripped into your system through IV.  A typical infusion can take anywhere from 2-4 hours depending on the drip rate your infusion professional sets.  Mine generally took about 3 hours. Loading doses are at 0, 2 and 6 weeks.  This means day 1 you will get an infusion, 2 weeks later another one, and 4 weeks after that another one.  Once the loading dosing is done you will start a cycle of every 8 weeks.  This can be increased both in dose size and frequency up to every 4 weeks.  Because of this being a more detailed process for both patient and provider it is usually not given as an initial course of treatment until other therapies such as Enbrel and Humira have failed.

Simponi:(golimumab)
Simponi is again another TNF-Alpha inhibitor.  It is a self injectable.  It is one of the newer biologicals and was approved in the US in 2009 for Psoriatic Arthritis.After this medication we hit a dry spell on approvals until last year.  Simponi is given as a self injectable for PsA.  It is also offered as an infusion for RA.

Simponi dosing is at week 0, 2, 4 and then every 4 weeks thereafter. So first dose, then 2 weeks later another dose, then 2 weeks later another and thereafter every 4 weeks.  It's big claim to individuality is that it was the first self injectable biological that could be administered only 1 time a month (less poking your own fat!).

Cimzia:(certolizumab pegol)
Cimzia was approved for PsA in September of 2013.  It is yet another TNF-Alpha inhibitor (because if all the others don't work we should keep beating that dead horse, sorry personal soap box).  Loading doses are 2 syringes at week 0, 2 and 4 (see Simponi loading schedule above) and then will be either 1 syringe every 2 weeks or 2 syringes every 4 weeks.  It is also a self stabber.

Stelara:(ustekinumab)
Finally something a little different!  Stelara was approved in the US in September 2013.  It is also a biological that inhibits proteins, but inhibits  interleukin 12 (IL-12) and interleukin 23 (IL-23) rather than TNF-Alpha.  It is also the first biological only targeted at Psoriatic Disease.  It is given by self injection.  Loading doses are at week 0 and week 4.  After that it is given every 3 months.

Otezla:(apermilast)
Last but not least we have the new comer.  Otezla was approved earlier this year in March.  It inhibits the protein phosphodiesterase 4, or PDE4.Otezla is an ORAL medication.  The loading is done over 5 days gradually increasing the dose to the maintenance dose of 2 30mg pills per day (one am and one pm). I can't seem to find any information on if this medication is actually a biological, but my own opinion is it looks like it will probably be classified as a DMARD rather than a biological.  I'm also not finding much information on if like other DMARDs it can be taken in conjunction with biologicals or stacked with another DMARD.  Because this medication is so very new I'm having a very hard time finding much more than the advertising propaganda, but I'm sure over the next year a lot more will become available as it is prescribed more frequently.

So there you have the heavy hitters of our little corner of the psoriatic medicine cabinet.  I will try to get to DMARDs again in more detail soon and probably anti inflammatories and steroids in future posts.  Below are pics of when I was self injecting Cimzia and my Remicade infusion for anyone who wants to see how that works.

Happy Monday everyone!

~Heather

Shooting Cimzia in my belly fat roll

Pushing that Remicade into my blood.

Proteins that increase the growth and function of white blood cells, which are found in your immune system.
Proteins that increase the growth and function of white blood cells, which are found in your immune system.