Biologic therapy for Rheumatoid arthritis Paul Etau Ekwom Physician and Rheumatologist
Objectives Case presentation of patient with rheumatoid arthritis on a biologic therapy. Discuss biologic therapy Way forward.
Outline Case presentation Definition/Introduction Classes In the horizon Kenya? Summary
Case presentation K.N.M 49 yr old business lady who retired from KNH on medical grounds Known to have (seropositive) Rheumatoid arthritis for past 13 yrs (since 1998). She also has Hypertension and is on treatment. Synthetic DMARDS use for the past 7 years.
Synthetic Dmards: Methotrexate at 25 mg/ wk Hydroxychloroquine 200 mg twice daily Sulfasalazine 1 g TDS Leflunomide 20 mg daily NSAIDs, Meloxicam 7.5 mg daily Prednisone 10 mg daily Received I.M methylprednisolone with flares (which had become frequent)
case presentation 10/11/11: persistent high disease activity Simplified Disease Activity Index :39 tender joint count: 12 Swollen joint count:12 Patient global 8 Physician global 7.8 cm HAQ (Health assessment questionnaire) score:1.4 pain 9.3 cm fatigue 9.5 cm on VAS morning stiffness for 30 minutes CRP positive and ESR 20 mm/hr.
case presentation Patient informed about biologic therapy D/w Chief pharmacist Tociluzimab available on compassionate ground. Patient educated about Tociluzimab (benefits, and adverse effects ) She had no h/o diverticulitis Baseline tests were conducted X ray chest HIV HB and HCV screening Mantoux Baseline Lipid profile Blood count Liver function test.
Tociluzumab administration Tociluzimab 640 mg administered over 1 hour on the 19/03/11. Other meds MTX 10 mg weekly. Anti-Hypertensive medication and artovastatin.
Follow up Monthly tociluzimab infusion and weekly 10 mg methotrexate. DATE SDAI HAQ FATIGUE PAIN EMS CRP ESR 19/11/11 39 1.4 9.5 8 30 MINS POSITIVE 20 17/12/11 8.5 0.1 2.4 2.5 0ccasional positive 11 14/1/12 0 0 0 0 0 negative 9 11/2/12 0 0 0 0 0 Negative 0 17/3/12 0.5 0 0.2 0 0 Negative 5
Biologic DMARDS DMARDS that target cytokines or cellular targets. First approved in 1998 (Etanercept). Effective and have revolutionized outcome of rheumatoid arthritis. Their use is cost effective. Nine approved (FDA/EMEA)
Biologic in common use Woodrick, R. S. & Ruderman, E. M. Nat. Rev. Rheumatol. 7, 639 652 (2011);
Newer biologics Kinase inhibitors: oral biologics Effective and safe in Ph II trials. Spleen tyrosine kinas inhibitor: Fostamatinib Janus kinase inhibitors: Tofacitinib
Rational biologic use Screening of patients prior for HIV,HBV,HCV and Tuberculosis. Vaccination for pneumonia, influenza and herpes zoster prior to use. Treatment regimens: Initial treatment in Early rheumatoid arthritis. After unsuccessful initial synthetic DMARD use (after 6/12) of treatment. In patients with poor prognostic factors. After failure of another biologic agent. Assess efficacy of agent after 12-16 weeks of treatment. If target not achieved, switch.
Which biologic? National guideline Biologic naïve vs experienced. Local availability, supply Rheumatoid factor positivity. Cost Special circumstances : Pregnancy, HIV, HBV and presence of malignancy.
Adverse effects Anaphylaxis Infections Malignancies: non-melanoma skin cancers. Cardiovascular adverse effects Withdrawals from treatment
Way forward for Kenya Registry for patients on biologics with regular returns. Advocacy to improve access, availability through public health providers, concessions and subsidies. Need to recognize persistent high or moderate activity and it s impact in patients quality of life, disability and socioeconomic decline.
Summary Biologics are part of treatment for rheumatoid arthritis in patients with poor prognostic factors and in patients with high or moderate disease activity after at least six months of synthetic DMARD treatment at maximal or tolerated dose. Adverse effects occur Need to assess effect a.fter 12-16 weeks of treatment. Kenya guideline for use of biologic and development of a registry is necessary.
Ejok!