Targeted adalimumab treatment can optimize long-term outcomes for patients with early rheumatoid arthritis, study suggests

Results of a study of 1032 patients with early (less than one year), active RA initially assessed response to treatment after 26 weeks with ADA 40mg every other week + MTX versus MTX alone. Results show that 44% of patients treated with the combination therapy achieved the target of sustained low disease activity at week 26, versus 24% of those treated with MTX alone. Patients reaching the target on ADA+MTX were considered responders and then further randomised to continue or withdraw from treatment with ADA 40mg every other week.

Patients who continued treatment maintained good clinical, radiographic and functional responses through to week 78, including a high proportion achieving higher measures of disease control. 77% achieved ACR70*, 86% reached DAS remission (DAS28≤2.6**) and 89% had no radiographic progression***. Interestingly, the majority of patients who had treatment withdrawn also showed good outcomes: 65% and 66% achieved ACR70 response and DAS28≤2.6**, respectively, and 81% showed no radiographic progression. The results in those patients discontinuing ADA indicate that it may be possible to withdraw ADA treatment in specific patients, without impacting long term patient outcomes.

"Data from the OPTIMA study has confirmed previous studies in showing that initial and continued adalimumab treatment in early RA can ensure that higher levels of disease control can be achieved and maintained," said Professor Paul Emery, Leeds Teaching Hospital, Leeds, England, and EULAR President. "Importantly, results of this first global study assessing biologic free disease control demonstrate that it may be possible to successfully withdraw anti-TNF therapy in certain patients and maintain long term positive outcomes although further studies in this area are needed."

Safety findings over the whole study period were generally similar to the profile seen with anti-TNF treatments in the treatment of active RA. Adverse events were evaluated for 850 patients who received ADA: serious adverse events included 9 deaths (1.0 per 100 patient years (/100PY)), 39 serious infections (4.4/100PY); 11 malignancies (1.2/100PY) including 5 non-melanoma skin cancers (0.6/100PY); 8 opportunistic infections (excluding tuberculosis) (0.9/100PY); with 4 confirmed as tuberculosis (0.5/100PY).

Note:

*ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate), patient assessment, physician assessment, pain scale and disability/functional questionnaire. ACR20 refers to a 20% improvement in tender/swollen joint counts, as well as three of the five other criteria. ACR50 refers to a 50% improvement and ACR70 refers to a 70% improvement.

**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is. It assesses number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR, a blood marker of inflammation), and the patient's 'global assessment of global health'. A higher score indicates more active disease. DAS28≤2.6 has been defined as an indicator of remission

*** Increase of ≤0.5 in total sharp score (TSS), a radiographic damage scoring system, during treatment