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Abstract Number: 1594

Clinical and Radiological Outcomes After One Year of Remission Steered Combination Treatment in Patients with Early Rheumatoid and Undifferentiated Arthritis

L. Heimans1, K.V.C. Wevers-de Boer1, K. Visser1, H.K. Ronday2, M. van Oosterhout3, J. H. L. M. Van Groenendael4, A.J. Peeters5, G. Steup-Beekman6, G. Collee7, P.B.J Sonnaville8, B.A. Grillet9, Tom Huizinga1 and C.F. Allaart1, 1Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Rheumatology, Haga Hospital, The Hague, Netherlands, 3Rheumatology, Groene Hart Hospital, Gouda, Netherlands, 4Franciscus Hospital, Roosendaal, Netherlands, 5Rheumatology, Reinier de Graaf Gasthuis, Delft, Netherlands, 6Rheumatology, Bronovo Hospital, Netherlands, 7MCH, The Hague, Netherlands, 8Admiraal de Ruyter Ziekenhuis, Goes, Netherlands, 9Department of Rheumatology, Zorgsaam Hospital, Terneuzen, Netherlands

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: clinical trials, remission and rheumatoid arthritis (RA)

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Session Information

Title: Plenary Session II: Discovery 2012

Session Type: Plenary Sessions

Background/Purpose:

To evaluate the 1 year clinical and radiological outcomes of remission steered therapy in early arthritis patients treated aiming at remission (DAS<1.6).

Methods:

In the IMPROVED study 610 patients were included with early rheumatoid or undifferentiated arthritis (RA or UA). All patients started with methotrexate (MTX) 25mg/wk and prednisone 60mg/day tapered to 7.5mg/day in 7 weeks. Patients in remission (DAS<1.6) after 4 months (early remission) tapered prednisone to zero and, when in remission at 8 months, tapered MTX. Patients not in early remission were randomized either to a combination of MTX 25mg/wk, hydroxychloroquine 400mg/day, sulphasalazine 2000mg/day and prednisone 7.5mg/day (arm 1) or to adalimumab (ADA) 40mg/2weeks with MTX 25mg/wk (arm 2). If not in remission after 8 months, patients in arm 1 switched to ADA+MTX and patients in arm 2 increased ADA to 40mg/week. Proportions of remission and radiological progression measured by Sharp-van der Heijde scoring method after one year follow up were compared between the different treatment strategies.

Results:

After 4 months 375 patients (61%) achieved early remission and 221 (36%) did not, of which 161 patients were randomized, 83 to arm 1 and 78 to arm 2. In 62 (10%) patients the protocol was not followed, 12 were lost to follow up after 4 months and in total 34 after 1 year. Of those in early remission 361 (96%) tapered prednisone after 4 months and 200 (53%) tapered MTX after 8 months. After 1 year, remission was achieved in 257 (69%) patients and 119 (32%, 20% of all patients) were in drug free remission.

Patients in arm 1 and 2 achieved remission in similar proportions after 8 months (30 (36%) versus 27 (35%), p=1.0), but after 1 year patients in arm 2 more often achieved remission than in arm 1 (32 (41%) vs 21 (25%), p=0.01). Patients in arm 2 who at 8 months tapered ADA+MTX combination to MTX monotherapy, more often remained in remission after one year than patients tapering poly-DMARDs+prednisone to MTX monotherapy in arm 1 (17/26 (65%) vs 11/30 (37%), p=0.02). After failing to achieve remission on poly-DMARDs+prednisone, 6/24 patients (18%) who switched to ADA achieved remission after one year, compared to 8/27 (30%) who failed on ADA+MTX and increased ADA (p=0.2). Of the total study population 53% were in remission after 1 year. Median (IQR) radiological damage progression after 1 year was 0(0-0) in patients who achieved early remission, and 0(0-0) and 0(0-0) in arms 1 and 2, respectively (p=0.2).

Conclusion:

After one year of remission steered combination treatment, 53% of the patients with early arthritis achieved remission. Patients in early remission after initial treatment with MTX and prednisone most often achieved remission after one year (69%) and 32% were in drug free remission. Patients who failed to achieve early remission benefited more from a treatment strategy with adalimumab than with multiple DMARDs+prednisone. In this treat-to-remission cohort, radiological damage progression after 1 year was negligible in all patients.


Disclosure:

L. Heimans,
None;

K. V. C. Wevers-de Boer,
None;

K. Visser,
None;

H. K. Ronday,
None;

M. van Oosterhout,
None;

J. H. L. M. Van Groenendael,
None;

A. J. Peeters,
None;

G. Steup-Beekman,
None;

G. Collee,
None;

P. B. J. Sonnaville,
None;

B. A. Grillet,
None;

T. Huizinga,
None;

C. F. Allaart,
None.

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