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WITHDRAWING METHOTREXATE after BOTH VERSUS only SECOND DOSE of the CHADOX1 NCOV-19 VACCINE in PATIENTS with AUTOIMMUNE INFLAMMATORY ARTHRITIS: TWO INDEPENDENT RANDOMIZED CONTROLLED TRIALS (MIVAC i and II)
Annals of the Rheumatic Diseases ; 81:208-209, 2022.
Article in English | EMBASE | ID: covidwho-2009182
ABSTRACT

Background:

Pausing methotrexate (MTX) for two to four weeks, improved immunogenicity of infuenza vaccination in patients with rheumatoid arthritis (RA), albeit a risk of disease fare (1). This guided the framing of guidelines on MTX withdrawal for COVID-19 vaccination (2). However, evidence for MTX withdrawal for COVID-19 vaccination is limited to observational studies only.

Objectives:

To compare the efficacy and safety of holding MTX after each (MIVAC 1) and only after the second dose (MIVAC II) of the ChAdOx1 vaccine versus continuation of MTX in two randomized controlled trials (RCTs).

Methods:

Two single centre, investigator-blinded, RCTs were conducted in patients with RA or Psoriatic arthritis (PsA) on stable doses of MTX without prior COVID-19 (CTRI reg. no. MIVAC I CTRI/2021/07/03463 & MIVAC II CTRI/2021/07/035307). In MIVAC I, unvaccinated patients were randomised (11) to hold or continue MTX for two weeks after each dose of the vaccine. MIVAC II included patients who had continued MTX during the frst dose of ChA-dOx1 and were randomised (11) to hold or continue MTX for 2 weeks after the second vaccine dose. The primary outcome for both the trials was the anti-Receptor Binding Domain (RBD) antibody titres measured four weeks after the second vaccine dose (per protocol analysis). Secondary outcome was the fare rate, defned as an increase in disease activity scores (DAS28/cDAPSA) or physician intent to hike DMARDs.

Results:

250 patients were randomized for MIVAC 1 and 178 for MIVAC II and after due exclusions, 158 and 157 were eligible for analysis respectively (Figure 1). In MIVAC I, median anti-RBD titres were signifcantly high in the MTX hold group [2484 (1050-4388) versus 1147(433-2360), p=0.001] but the fare rate was higher in the hold group [20 (25%) versus 6(8%) p=0.005] compared to continue group. In MIVAC II median anti-RBD titres were signifcantly high for the MTX hold group [2553 (1792-4823) versus 990 (356-2252), p=0.001] when compared to continue group but there was no difference in the fare rate between the groups [9(11.8%) and 4(7.9%), p=0.15] (Table 1). Since both were parallel studies in similar population, MTX hold arms across both the trials were compared for anti-RBD titres and fare. There was no difference in the anti-RBD titres [p=0.2] between the groups. In MIVAC I, 29(36.25%) patients had reported fare (19 in either frst or second dose, 10 for both doses) when compared to MIVAC II where only 9(11.84%) patients had reported fare after the second dose (P <0.001).

Conclusion:

Holding MTX after both the doses or only after the second dose of ChAdOx1 yields higher anti-RBD antibody titres as compared to continuing MTX. Comparing across the trials, holding MTX only after the second dose appears to be non-inferior to holding MTX after both doses of the vaccine with a lesser risk of fare.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Topics: Vaccines Language: English Journal: Annals of the Rheumatic Diseases Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Topics: Vaccines Language: English Journal: Annals of the Rheumatic Diseases Year: 2022 Document Type: Article