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adalimumab

Journal Club

Is tofacitinib effective in treating psoriatic arthritis?

November 7, 2017
Is tofacitinib effective in treating psoriatic arthritis?

As you can recall, psoriatic arthritis is a type of autoimmune disease that affects people with psoriasis.  In certain cases, it can look like rheumatoid arthritis, but it is very different condition.  Rheumatologists use medications like sulfasalazine, methotrexate, Otezla, as well as multiple TNF inhibitors such as Enbrel and Humira to treat psoriatic arthritis. Other medications include Cosentyx, an interleukin 17 inhibitor, as well as Orencia.

Tofacitinib or adalimumab versus placebo for psoriatic arthritis

Recently, researchers studied whether tofacitinib, also known as Xeljanz, could also give some benefit for people with psoriatic arthritis.  A recent study published in the New England Journal of medicine reported the results of the oral psoriatic arthritis trial (OPAL) Broaden, the phase 3 trial which evaluated the efficacy and safety of tofacitinib and adalimumab, also known as Humira, compared to placebo.  Here are the results.

Methods

Design

  • The study lasted 12 months.
  • Everyone had to be on at least one conventional or non-biologic DMARD such as methotrexate, sulfasalazine, or leflunomide.
  • The trial was a randomized, placebo-controlled, double-blind phase 3 trial.
  • People were randomly assigned to receive the following regimens:
    • Tofacitinib 5 mg taken orally twice daily
    • Tofacitinib 10 mg taken orally twice daily
    • Adalimumab 40 mg subcutaneously once every two weeks
    • Placebo with a switch to 5 mg dose of two presented at month three, or placebo with a switch to 10 mg dose of two presented at month three
  • Everyone had to be on a stable background dose of either, methotrexate, sulfasalazine, or leflunomide.

The trial was sponsored by Pfizer.

Primary and secondary endpoints

  • The two primary endpoints assessed at month three were:
    • The percentage of people who achieved an American College of Rheumatology 20 (ACR20) response
    • And the change from baseline Health Assessment Questionnaire – Disability Index (HAQ-DI).

The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20

  • Secondary endpoints included the amount of people who achieved an ACR50 or more and an ACR70 or more. The researchers looked at the improvement in people’s psoriasis as well as enthesitis (i.e., inflammation of tendons, ligaments, and bursae).
  • The researchers also looked at x-rays of the hands and feet at baseline and at month 12, to see whether they had worsened on treatment.
  • They assessed safety by means of spontaneous reporting of adverse events – physical examinations, and clinical laboratory test.

Results

Efficacy

373 people completed the trial.

  • At 3 months, ACR20 response was:
    • 50 % in the 5-mg tofacitinib group
    • 61% in the 10-mg tofacitinib group
    • 52% in the adalimumab group
    • 33% in the placebo group
  • At 3 months, the ACR 50 response was:
    • 28% in the 5-mg tofacitinib group
    • 40% in the 10-mg tofacitinib group
    • 33% in the adalimumab group
    • 10% in the placebo group
  • At 3 months, the ACR70 response was:
    • 17% in the 5-mg tofacitinib group
    • 14% in the 10-mg tofacitinib group
    • 19% in the adalimumab group
    • 5% in the placebo group
  • At month 12, 90% among people who received tofacitinib or adalimumab did not show any worsening of their disease on x-ray.
  • Both tofacitinib and adalimumab performed better than placebo
  • They both performed similarly but in all fairness, the study wasn’t powered to accurately compare the two.

Safety

  • At 3 months, the percentage of people with adverse events:
    • 39% in the 5-mg tofacitinib group
    • 45% in the 10-mg tofacitinib group
    • 46% in the adalimumab group
    • 35% in the placebo group
  • At 3 months serious adverse events occurred in:
    • 3% of the 5-mg tofacitinib group
    • 1% of the 10-mg tofacitinib group
    • 1% of the adalimumab group
    • 1% of the placebo group
  • At 12 months, the percentage of people with serious adverse events
    • 7% of people in the 5-mg tofacitnib group
    • 4% of the people in the 10-mg tofacitinib group
    • 8% in the adalimumab group
  • The most common adverse events were sinusitis, upper respiratory tract infections, and headaches.
  • One cardiac arrest happened in the placebo group at month 4, i.e., 1 month after switching to tofacitinib.
  • There were 4 cases of shingles that occurred in the groups receiving tofacitinib.
  • Three cases of cancer occurred: day 1, day 11, and day 231 of the trial.

Conclusion

Tofacitinib is effective in treating psoriatic arthritis at 3 months and after one year of treatment.  The rates of adverse effects are more than placebo but comparable to current standard of care.

References

Mease P, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. 2017 Oct 19;377(16):1537-1550.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

Diseases and Conditions Self-Injection Videos

How to inject Humira, Enbrel, Simponi, and Cimzia

August 28, 2017
Video demonstrations on how to how to inject Humira, Enbrel, Simponi, and Cimzia

Humira®, Enbrel®, Simponi®, and Cimzia® are medications commonly prescribed for rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis.  All of these come in self-injectable pens or pre-filled syringes.  You will be asked to inject these yourself or by a love one, in the comfort of your home.  Today, we’re going to go over how to inject these self-injectable medications.

Preparing for your injection

  • Keep your medication stored in the refrigerator until use
    • Before injecting medication, take the autoinjector out of the refrigerator.
    • Allow it to warm up to room temperature.
  • Pick a place in your house that is clean and has room for your materials (such as the kitchen table).
  • Wash your hands thoroughly with either:
    • Soap & water
    • Hand sanitizer
  • Chose an area to inject – Thigh or Stomach.
    • Chose an area that is intact and clear.
    • It should not have any of the following:
      • Cuts
      • Scrapes
      • Bruises
      • Psoriasis patches
      • If you have extensive psoriasis, inject between patches
      • Moles
      • Scars
    • Please rotate area each time you inject (shown in picture below).

Areas to inject subcutaneous medication

By British Columbia Institute of Technology (BCIT). Download this book for free at http://open.bccampus.ca [CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)], via Wikimedia Commons

  • Cleanse chosen area
    • Cleanse chosen area with either of the following:
      • Alcohol swab
      • Alcohol and a cotton ball
    • Use the chosen alcohol material to “swipe” area
      • Can either use a circular motion or wipe in “strips”
      • Allow the area to dry

The injection

  • Take off the white cap, observe the medication in the window to be sure that it is clear (no cloudiness or crystals.)
    • You will see a small air bubble within the window, this is normal and will not cause harm when injecting
  • Press down firmly on the clean area of skin, so that the pen is flush with the skin (90-degree angle).
    • The pen needle will not eject unless pressed firmly to skin

For Cimzia® and other medications that come in prefilled syringes

  • Pinch the skin around the injection site and insert the needle at a 45-degree angle
  • Press in the plunger slowly

You may notice the plunger is hard to press this is due to the size of the medication, be sure to continue to inject slowly to administer all medication

  • Press button to inject the medication.
    • You may feel a slight pinch as the needle enters your skin, and tingling as the medication is administered
    • If you have trouble pressing the button try lifting the pen off your skin, and repressing the pen firmly to the area
  • Hold for 15 seconds.
    • Window will become colored (yellow) but continue to hold dose for at least 15 seconds to ensure that all medication is administered

What to do after the injection

  • Lift the pen up from skin and place the whole pen into the sharps container.
    • If you do not have a sharps container available, contact your pharmacy/doctor’s office about obtaining one
      • In the meantime, you may use an old coffee container with a lid
    • Some hospitals take full Sharps Containers for disposal. Here at the office we do not. Contact your pharmacy for more information about the disposing of your Sharps Container.
  • Discard remaining materials in the trash (cap, alcohol swabs, etc.)

If you have any concerns about your medication (e.g., excessive pain, swelling, redness bruising, bleeding, fever, breathing problems), please contact your rheumatologist.

For more information

Humira® – Abbvie

Enbrel® – Amgen

Simponi® – Janssen

Cimzia® – UCB

Jessica Farrell, PharmD.  Clinical Pharmacist, The Center for Rheumatology/Associate Professor, Albany College of Pharmacy and Health Sciences

With the help of Autumn Koniowka. Doctor of Pharmacy Candidate Class of 2018, Albany College of Pharmacy and Health Sciences, and Megan Phillips. Doctor of Pharmacy Candidate Class of 2018, Albany College of Pharmacy and Health Sciences.

A special thanks to Tammy Garren, PhD. Instructional Designer, Center for Innovative Learning, Albany College of Pharmacy and Health Sciences.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

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