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AB0417 Efficacy and safety of methotrexate and leflunomide as a combination therapy in rheumatoid arthritis patients with high disease activity presenting at a tertiary care setting in pakistan
  1. B Salim,
  2. S Samreen,
  3. A Nasim,
  4. H Gul,
  5. A Masood
  1. Rheumatology, Rawalpindi, Pakistan


Background In the management of rheumatoid arthritis (RA), the goal is remission. However it is not easy to attain this goal in all patients. Its not only the high disease activity, but rather other factors like availability and cost of biologics in developing countries. Therefore various combination therapies of conventional DMARDs are in vogue in such scenarios. Methotrexate (MTX) and Leflunomide (LEF) in combination is an effective option which can be fairly utilized in resource constraint settings to induce remission.

Objectives To study the efficacy and safety profile of MTX+LEF combination in patients with active RA at 24 weeks.

Methods This is a quasi-experimental study conducted at Rheumatology department, Fauji Foundation Hospital, Rawalpindi. 95 patients with active RA despite optimal dose (20–25 mg/week) of MTX. Leflunomide 20mg/day was added. Patients underwent clinical and laboratory review at 0, 4, 12 and 24 weeks to note down primary efficacy end points and adverse effects.

Results Ninety five patients were enrolled with a mean age (years) ± SD of 51.7±8.9 and a mean duration of disease (years) of 8.6±7.1.Patients had active disease at baseline with a mean disease activity score (DAS28) of 5.99±0.6. At 24 weeks the mean change in tender joint count (TJ), swollen joint count (SJ), patients pain score on visual analogue scale (VAS) and DAS 28 were all statistically significant (p-value 0.000).The mean change in m HAQ was also statistically significant (p-value 0.000).

At 6 months the most frequent side effects (though mostly mild); were abdominal pain and nausea. 78 patients (79.1%) continued with the combination therapy. Only 3 patients stopped the treatment temporarily (due to raised ALT and vomiting).14 patients discontinued treatment mainly due to diarrhea, severe oral ulcers and markedly raised ALT.

Table 1.

Baseline clinical and demographic feature of patients enrolled for MTX+LEF combination therapy

Table 2.

Outcome/efficacy measure of MTX+LEF (n=95)

Conclusions MTX+LEF combination is an effective and safe option in RA patients failing MTX monotherapy provided regular clinical and laboratory monitoring is done.

Disclosure of Interest None declared

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